Invokamet

Diabetic Ketoacidosis, Congestive Heart Failure, Type 1 Diabetes + 16 more

Treatment

22 FDA approvals

20 Active Studies for Invokamet

What is Invokamet

Metformin

The Generic name of this drug

Treatment Summary

Metformin is a medication used to treat type 2 diabetes. It is the most commonly prescribed drug for this condition and is used by more than 120 million people around the world. Metformin works by lowering blood sugar levels without causing hypoglycemia. It also helps reduce insulin resistance and fasting insulin levels, resulting in modest weight loss for some patients. Metformin was approved for use in Canada in 1972 and in the United States in 1995. It is available in both regular and extended-release forms.

Metformin Hydrochloride

is the brand name

image of different drug pills on a surface

Invokamet Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Metformin Hydrochloride

Metformin

2002

1263

Approved as Treatment by the FDA

Metformin, otherwise known as Metformin Hydrochloride, is approved by the FDA for 22 uses which include Heart Failure and Heart Failure .

Heart Failure

Used to treat Heart Failure in combination with Dapagliflozin

Heart Failure

Used to treat NYHA Functional Class II-IV Heart Failure in combination with Dapagliflozin

Kidney Failure

Used to treat End Stage Renal Disease (ESRD) in combination with Dapagliflozin

Type 2 Diabetes

Used to treat Type 2 Diabetes Mellitus in combination with Dapagliflozin

Chronic Kidney Disease

Used to treat Chronic Kidney Disease (CKD) in combination with Dapagliflozin

Renal Insufficiency

Used to treat decreased estimated glomerular filtration rate in combination with Dapagliflozin

Ejection fraction decreased

Used to treat Ejection fraction decreased in combination with Dapagliflozin

Type 2 Diabetes Mellitus

Used to treat Type 2 Diabetes Mellitus in combination with Dapagliflozin

Ketosis

Used to treat Diabetic Ketoacidosis in combination with Saxagliptin

Diet

Used to treat Diet in combination with Dapagliflozin

Hospitalizations

Used to treat Hospitalizations in combination with Dapagliflozin

Congestive Heart Failure

Used to treat Heart Failure in combination with Dapagliflozin

Physical Activity

Used to treat Exercise in combination with Dapagliflozin

Chronic Kidney Disease (CKD)

Used to treat Chronic Kidney Disease (CKD) in combination with Dapagliflozin

Type 1 Diabetes Mellitus

Used to treat Type 1 Diabetes Mellitus in combination with Sitagliptin

Diabetic Ketoacidosis

Used to treat Diabetic Ketoacidosis in combination with Saxagliptin

Cardiovascular Mortality

Used to treat Cardiovascular Mortality in combination with Dapagliflozin

Diabetes Mellitus

Used to treat uncontrolled diabetes in combination with Rosiglitazone

Cardiovascular Disease

Used to treat Cardiovascular Risk in combination with Dapagliflozin

Cardiovascular Diseases

Used to treat established cardiovascular disease in combination with Dapagliflozin

Heart failure

Used to treat Heart Failure in combination with Dapagliflozin

Type 1 Diabetes

Used to treat Type 1 Diabetes Mellitus in combination with Sitagliptin

Effectiveness

How Invokamet Affects Patients

Insulin is a hormone that helps control blood sugar levels, but in people with Type 2 diabetes this hormone is not working as it should. Metformin helps improve insulin's effectiveness by decreasing the amount of glucose made by the liver and reducing the amount of glucose that is absorbed by the intestines. It also helps the body use insulin better. In a study, people taking metformin had lower fasting plasma glucose levels (down 59 mg/dL) and lower glycosylated hemoglobin (HbA1c) levels (down 1.4%) than those taking a placebo.

How Invokamet works in the body

Metformin works by decreasing the amount of glucose produced in your liver, decreasing how much glucose is absorbed from food, and increasing how sensitive your body is to insulin. It does this by blocking a specific protein in your liver which helps produce energy, triggering a chain reaction that ends with increased glucose metabolism in your intestines and decreased glucose production in your liver. Metformin also increases a hormone in your gut called glucagon-like peptide 1, which helps your body use glucose more efficiently. All these pathways combined work to lower blood glucose levels and control type II diabetes.

When to interrupt dosage

The advisable dose of Invokamet is contingent upon the diagnosed condition, such as Diet, inadequate response to metformin and Diabetic Ketoacidosis. The degree of dosage fluctuates as per the delivery approach (e.g. Oral or Tablet - Oral) featured in the table underneath.

Condition

Dosage

Administration

inadequate response to metformin

500.0 mg, , 1000.0 mg, 750.0 mg, 850.0 mg, 250.0 mg, 500.0 mg/mL, 660.0 mg, 780.0 mg

Tablet, film coated, extended release, Oral, Tablet, film coated, extended release - Oral, , Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Kit, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, For suspension, extended release - Oral, For suspension, extended release, Kit - Oral

Cardiovascular Diseases

500.0 mg, , 1000.0 mg, 750.0 mg, 850.0 mg, 250.0 mg, 500.0 mg/mL, 660.0 mg, 780.0 mg

Tablet, film coated, extended release, Oral, Tablet, film coated, extended release - Oral, , Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Kit, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, For suspension, extended release - Oral, For suspension, extended release, Kit - Oral

Insulin Resistance

500.0 mg, , 1000.0 mg, 750.0 mg, 850.0 mg, 250.0 mg, 500.0 mg/mL, 660.0 mg, 780.0 mg

Tablet, film coated, extended release, Oral, Tablet, film coated, extended release - Oral, , Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Kit, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, For suspension, extended release - Oral, For suspension, extended release, Kit - Oral

Renal Insufficiency

500.0 mg, , 1000.0 mg, 750.0 mg, 850.0 mg, 250.0 mg, 500.0 mg/mL, 660.0 mg, 780.0 mg

Tablet, film coated, extended release, Oral, Tablet, film coated, extended release - Oral, , Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Kit, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, For suspension, extended release - Oral, For suspension, extended release, Kit - Oral

Diabetes Mellitus

500.0 mg, , 1000.0 mg, 750.0 mg, 850.0 mg, 250.0 mg, 500.0 mg/mL, 660.0 mg, 780.0 mg

Tablet, film coated, extended release, Oral, Tablet, film coated, extended release - Oral, , Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Kit, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, For suspension, extended release - Oral, For suspension, extended release, Kit - Oral

Congestive Heart Failure

500.0 mg, , 1000.0 mg, 750.0 mg, 850.0 mg, 250.0 mg, 500.0 mg/mL, 660.0 mg, 780.0 mg

Tablet, film coated, extended release, Oral, Tablet, film coated, extended release - Oral, , Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Kit, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, For suspension, extended release - Oral, For suspension, extended release, Kit - Oral

Type 2 Diabetes

500.0 mg, , 1000.0 mg, 750.0 mg, 850.0 mg, 250.0 mg, 500.0 mg/mL, 660.0 mg, 780.0 mg

Tablet, film coated, extended release, Oral, Tablet, film coated, extended release - Oral, , Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Kit, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, For suspension, extended release - Oral, For suspension, extended release, Kit - Oral

Chronic Kidney Disease

500.0 mg, , 1000.0 mg, 750.0 mg, 850.0 mg, 250.0 mg, 500.0 mg/mL, 660.0 mg, 780.0 mg

Tablet, film coated, extended release, Oral, Tablet, film coated, extended release - Oral, , Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Kit, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, For suspension, extended release - Oral, For suspension, extended release, Kit - Oral

Diabetic Ketoacidosis

500.0 mg, , 1000.0 mg, 750.0 mg, 850.0 mg, 250.0 mg, 500.0 mg/mL, 660.0 mg, 780.0 mg

Tablet, film coated, extended release, Oral, Tablet, film coated, extended release - Oral, , Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Kit, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, For suspension, extended release - Oral, For suspension, extended release, Kit - Oral

Physical Activity

500.0 mg, , 1000.0 mg, 750.0 mg, 850.0 mg, 250.0 mg, 500.0 mg/mL, 660.0 mg, 780.0 mg

Tablet, film coated, extended release, Oral, Tablet, film coated, extended release - Oral, , Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Kit, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, For suspension, extended release - Oral, For suspension, extended release, Kit - Oral

Kidney Failure

500.0 mg, , 1000.0 mg, 750.0 mg, 850.0 mg, 250.0 mg, 500.0 mg/mL, 660.0 mg, 780.0 mg

Tablet, film coated, extended release, Oral, Tablet, film coated, extended release - Oral, , Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Kit, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, For suspension, extended release - Oral, For suspension, extended release, Kit - Oral

Diet

500.0 mg, , 1000.0 mg, 750.0 mg, 850.0 mg, 250.0 mg, 500.0 mg/mL, 660.0 mg, 780.0 mg

Tablet, film coated, extended release, Oral, Tablet, film coated, extended release - Oral, , Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Kit, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, For suspension, extended release - Oral, For suspension, extended release, Kit - Oral

Hospitalizations

500.0 mg, , 1000.0 mg, 750.0 mg, 850.0 mg, 250.0 mg, 500.0 mg/mL, 660.0 mg, 780.0 mg

Tablet, film coated, extended release, Oral, Tablet, film coated, extended release - Oral, , Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Kit, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, For suspension, extended release - Oral, For suspension, extended release, Kit - Oral

Heart Failure

500.0 mg, , 1000.0 mg, 750.0 mg, 850.0 mg, 250.0 mg, 500.0 mg/mL, 660.0 mg, 780.0 mg

Tablet, film coated, extended release, Oral, Tablet, film coated, extended release - Oral, , Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Kit, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, For suspension, extended release - Oral, For suspension, extended release, Kit - Oral

Type 1 Diabetes

500.0 mg, , 1000.0 mg, 750.0 mg, 850.0 mg, 250.0 mg, 500.0 mg/mL, 660.0 mg, 780.0 mg

Tablet, film coated, extended release, Oral, Tablet, film coated, extended release - Oral, , Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Kit, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, For suspension, extended release - Oral, For suspension, extended release, Kit - Oral

Polycystic Ovarian Syndrome

500.0 mg, , 1000.0 mg, 750.0 mg, 850.0 mg, 250.0 mg, 500.0 mg/mL, 660.0 mg, 780.0 mg

Tablet, film coated, extended release, Oral, Tablet, film coated, extended release - Oral, , Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Kit, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, For suspension, extended release - Oral, For suspension, extended release, Kit - Oral

Cardiovascular Disease

500.0 mg, , 1000.0 mg, 750.0 mg, 850.0 mg, 250.0 mg, 500.0 mg/mL, 660.0 mg, 780.0 mg

Tablet, film coated, extended release, Oral, Tablet, film coated, extended release - Oral, , Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Kit, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, For suspension, extended release - Oral, For suspension, extended release, Kit - Oral

Cardiovascular Mortality

500.0 mg, , 1000.0 mg, 750.0 mg, 850.0 mg, 250.0 mg, 500.0 mg/mL, 660.0 mg, 780.0 mg

Tablet, film coated, extended release, Oral, Tablet, film coated, extended release - Oral, , Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Kit, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, For suspension, extended release - Oral, For suspension, extended release, Kit - Oral

Ejection fraction decreased

500.0 mg, , 1000.0 mg, 750.0 mg, 850.0 mg, 250.0 mg, 500.0 mg/mL, 660.0 mg, 780.0 mg

Tablet, film coated, extended release, Oral, Tablet, film coated, extended release - Oral, , Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Kit, Solution, Solution - Oral, Tablet, coated, Tablet, coated - Oral, For suspension, extended release - Oral, For suspension, extended release, Kit - Oral

Warnings

Invokamet Contraindications

Condition

Risk Level

Notes

Liver Failure

Do Not Combine

Renal Insufficiency

Do Not Combine

Heart Arrest

Do Not Combine

Diabetic Ketoacidosis

Do Not Combine

Operative Surgery

Do Not Combine

Metabolic acidosis

Do Not Combine

Heart Failure

Do Not Combine

Renal Insufficiency

Do Not Combine

kidney function unknown

Do Not Combine

Hypovolemic Shock

Do Not Combine

serum creatinine above upper limit for age range

Do Not Combine

ethanol

Do Not Combine

Acute Coryza

Do Not Combine

Hypoxemia

Do Not Combine

Liver Failure

Do Not Combine

Acidosis, Lactic

Do Not Combine

Diabetic Ketoacidosis

Do Not Combine

Renal Insufficiency

Do Not Combine

Renal Insufficiency, Chronic

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Metformin may interact with Pulse Frequency

There are 20 known major drug interactions with Invokamet.

Common Invokamet Drug Interactions

Drug Name

Risk Level

Description

Abemaciclib

Major

The excretion of Abemaciclib can be decreased when combined with Metformin.

Procainamide

Major

The excretion of Procainamide can be decreased when combined with Metformin.

Topotecan

Major

The excretion of Topotecan can be decreased when combined with Metformin.

Abacavir

Minor

Metformin may decrease the excretion rate of Abacavir which could result in a higher serum level.

Aclidinium

Minor

Metformin may decrease the excretion rate of Aclidinium which could result in a higher serum level.

Invokamet Toxicity & Overdose Risk

The toxic dose of metformin in rats is 1g/kg when taken orally, and 500mg/kg when given intraperitoneally. In mice, the toxic dose is 1450mg/kg when taken orally and 420mg/kg when given intraperitoneally. Metformin can decrease the body's ability to absorb lactate, which can lead to a dangerous build-up of lactic acid in the bloodstream (lactic acidosis). Symptoms of lactic acidosis include fatigue, muscle pain, abdominal pain, difficulty breathing, and drowsiness. Risk factors for lactic acidosis include kidney damage, use

image of a doctor in a lab doing drug, clinical research

Invokamet Novel Uses: Which Conditions Have a Clinical Trial Featuring Invokamet?

There are currently 346 active clinical trials analyzing the potential of Invokamet to target Type 2 Diabetes, Type 1 Diabetes and inadequate response to metformin therapies.

Condition

Clinical Trials

Trial Phases

Chronic Kidney Disease

96 Actively Recruiting

Not Applicable, Phase 1, Phase 2, Phase 4, Phase 3, Early Phase 1

Cardiovascular Diseases

0 Actively Recruiting

Congestive Heart Failure

174 Actively Recruiting

Not Applicable, Phase 1, Early Phase 1, Phase 2, Phase 3, Phase 4

Type 1 Diabetes

110 Actively Recruiting

Phase 3, Not Applicable, Phase 2, Early Phase 1, Phase 1, Phase 4

Cardiovascular Disease

22 Actively Recruiting

Not Applicable, Phase 3, Phase 2

Type 2 Diabetes

157 Actively Recruiting

Not Applicable, Phase 1, Phase 2, Phase 3, Phase 4, Early Phase 1

Kidney Failure

36 Actively Recruiting

Phase 4, Phase 2, Phase 3, Not Applicable, Phase 1, Early Phase 1

Physical Activity

24 Actively Recruiting

Not Applicable, Phase 1, Phase 2

Insulin Resistance

0 Actively Recruiting

Renal Insufficiency

0 Actively Recruiting

Cardiovascular Mortality

0 Actively Recruiting

Ejection fraction decreased

0 Actively Recruiting

Hospitalizations

1 Actively Recruiting

Not Applicable

Diabetic Ketoacidosis

2 Actively Recruiting

Not Applicable, Phase 1, Phase 2

Polycystic Ovarian Syndrome

7 Actively Recruiting

Not Applicable, Phase 1

inadequate response to metformin

0 Actively Recruiting

Heart Failure

0 Actively Recruiting

Diet

4 Actively Recruiting

Not Applicable, Phase 1

Diabetes Mellitus

0 Actively Recruiting

Invokamet Reviews: What are patients saying about Invokamet?

5

Patient Review

6/20/2016

Invokamet for Type 2 Diabetes Mellitus

This drug is excellent at controlling blood sugar. However, a side effect is weight loss. I went from 210 Lbs to 176 Lbs in two months.

4.7

Patient Review

4/24/2018

Invokamet for Type 2 Diabetes Mellitus

I've lost 46 pounds since starting this treatment, and my A1C dropped from 12 to 8. I feel a lot better overall; the only problem is that my toes and fingers stay cold, but when rubbed they have good blood flow and will warm up.

4.7

Patient Review

9/27/2015

Invokamet for Type 2 Diabetes Mellitus

4.3

Patient Review

1/26/2017

Invokamet for Type 2 Diabetes Mellitus

My doctor put me on this medication, and after six months my A1C had risen from a 7 to almost a 10. In addition to making me very thirsty, I also had to urinate more frequently--particularly in the evening hours. Invokamet was not for me; the only good thing that came of it was that I lost about 15 pounds. Thankfully, I've since switched to Trajenta under my doctor's care and things are going much better.

4.3

Patient Review

3/18/2016

Invokamet for Type 2 Diabetes Mellitus

3.7

Patient Review

12/4/2014

Invokamet for Type 2 Diabetes Mellitus

1.7

Patient Review

8/1/2016

Invokamet for Type 2 Diabetes Mellitus

I lost 20 pounds in the first four months, and I haven't experienced any negative side effects so far.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about invokamet

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the difference between Invokana and Invokamet?

"The medicine works to remove sugar from the body by causing the sugar to be passed through urine. The medicine is called Invokana when it is taken as a single medicine. When the medicine is combined with the diabetes drug metformin, it is called Invokamet."

Answered by AI

What is Invokamet used for?

"INVOKAMET and INVOKAMET XR can be used to lower blood sugar (glucose), reduce the risk of major cardiovascular events, and improve glycemic control in adults with type 2 diabetes."

Answered by AI

What type of drug is Invokamet?

"Invokamet is a combination medication containing canagliflozin and metformin. Both of these medications work together to lower blood sugar levels in adults with type 2 diabetes."

Answered by AI

Is Invokamet the same as metformin?

"Invokana is not the same as metformin. They are both medicines that lower blood sugar levels, but they work in different ways."

Answered by AI

Clinical Trials for Invokamet

Image of Centre EPIC in Montreal, Canada.

Maple Syrup for Endurance Cycling Performance

18 - 45
Male
Montreal, Canada

The goal of this clinical trial is to learn whether maple syrup can be used as a natural carbohydrate source to help trained male cyclists perform better during long-duration cycling. The study also aims to learn how different amounts of maple syrup affect energy use in the body, stomach comfort, and feelings of effort and fatigue. The main questions the study aims to answer are: * Does consuming more carbohydrate from maple syrup help participants finish a 20-kilometer cycling time trial faster? * How do different amounts of maple syrup change how the body uses carbohydrates and fats during long exercise? * Are higher amounts of maple syrup easy for participants to tolerate without stomach problems? Researchers will compare four drinks: 1. A placebo drink (a look-alike drink with no calories), 2. A drink that provides 60 grams of carbohydrate per hour, 3. A drink that provides 90 grams per hour, and 4. A drink that provides 120 grams per hour. They will compare these drinks to see whether higher carbohydrate amounts lead to better cycling performance and how each dose affects comfort and metabolism. Participants will: * Attend a screening visit that includes a health check and a glucose tolerance test. * Complete a fitness test to measure their aerobic capacity and practice the cycling tests used in the study. * Take part in four separate exercise sessions in random order. Each session includes: * Drinking one of the four study beverages during 2 hours of steady cycling, * Completing two short, all-out 6-second sprints during the ride, * Completing a 20-kilometer cycling time trial as fast as possible, * Reporting stomach symptoms and perceptions of effort, * Providing breath, blood, urine, and sweat samples so researchers can measure how their body uses fuel. All drinks will look, taste, and smell similar so participants cannot tell which one they are receiving. Meals before each session will be provided to keep conditions the same across visits. This study may help athletes and active people choose natural carbohydrate sources that support both performance and comfort during long endurance exercise. The findings may also guide future research on the use of maple syrup as a sports nutrition option.

Waitlist Available
Paid Trial

Centre EPIC

Jonathan Tremblay, PhD

Mitacs

Image of National Association of Pasifika Organizations in Fayetteville, United States.

PILI Pasifika Program for Cardiometabolic Conditions

18+
All Sexes
Fayetteville, AR

In this study, the investigators are testing the effectiveness and implementation of the Community Health Workers (CHW)-delivered PILI Pasifika Program (PPP) Standard Facilitation or Enhanced Facilitation across 3 regions, the U.S. Affiliated Pacific Islands (USAPI), the continental U.S., and Hawai'i, among 600 Native Hawaiian and Pacific Islander (NHPI) participants in two settings, (clinical and non-clinical) over a 3-year period. The PPP is a 3-month lifestyle intervention that includes a Social Determinants of Health (SDOH) component and was NHPI-adapted from the Diabetes Prevention Program's Lifestyle Program, renamed to the PILI Lifestyle Program (PLP), which demonstrated effectiveness in improving weight, blood pressure, physical activity, and diet among NHPIs. The PPP consists of 8 lifestyle lessons and 4 SDOH activities delivered over a 3-month period. The investigators will conduct an effectiveness-implementation hybrid type 2 trial using a 3 (Region) x 2 (Setting) x 2 (Delivery Mode) factorial design. The long-term objective of this study is threefold: 1. To conduct an effectiveness-implementation hybrid 2 trial to test the effects of the PPP implementation strategies across different settings and modes of delivery among 600 NHPIs at risk for cardiometabolic-related conditions using an NHPI-approved and adapted evaluation framework. The investigators will also assess and compare the cost-effectiveness of the CHW-delivered PPP-Standard Facilitation and PPP-Enhanced Facilitation to support long-term sustainability. 2. To conduct a longitudinal Social Determinants of Health (SDOH) survey embedded within the trial to examine the reliability and validity of indices from 5 adapted SDOH instruments and to assess the associations between SDOH variables and chronic disease risk among NHPIs. 3. To implement and evaluate the contextually-based CHW training program on PPP delivery.

Waitlist Available
Has No Placebo

National Association of Pasifika Organizations (+1 Sites)

Joseph K Kaholokula, PhD

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We made a collection of clinical trials featuring Invokamet, we think they might fit your search criteria.
Go to Trials
Image of Vancouver General Hospital in Vancouver, Canada.

Natriuresis-Guided Diuretic Therapy for Heart Failure

18+
All Sexes
Vancouver, Canada

Heart failure is a chronic condition that causes congestion and frequent hospitalizations. Diuretic doses are usually adjusted based on clinical judgment without an objective measure of response. This study will test the feasibility of using point-of-care urine sodium measurements to guide up-titration or down-titration of loop diuretics in ambulatory patients with heart failure. Participants will be assigned to one of three groups based on congestion status. Groups 1 and 2 will be randomized 1:1 to natriuresis-guided therapy or standard care. Group 3 will be observational. The 90-day pilot trial will evaluate feasibility, clinical outcomes, and usability of a urine sodium-guided titration strategy.

Recruiting
Has No Placebo

Vancouver General Hospital

Image of Faculty of Health Sciences in Winnipeg, Canada.

Saskatoon Berries for Type 2 Diabetes

18 - 74
All Sexes
Winnipeg, Canada

Diabetes becomes epidemic in worldwide countries. Diabetes Canada indicated that 30% of adults in Manitoba are diabetes or prediabetes. Nine out of ten diabetic patients are type 2 diabetes (T2D). T2D is characterized by insulin resistance and obesity. Uncontrolled diabetes leads to serious consequences including heart attack, stroke, chronic renal failure, liver failure, blindness and low limb amputation. Most of hypoglycemic medications have certain side effects. Natural foods or nutraceuticals with hypoglycemic potential are expected to provide a safer management for diabetic patients. Saskatoon berry is a popular fruit in Canadian Prairie and Northern states in USA. Previous studies in the investigator's group demonstrated Saskatoon berry (SB) powder attenuated hyperglycemia, hyperlipidemia, insulin resistance, inflammation, liver steatosis and gut dysbiosis in diet-induced insulin resistant mice, a model for T2D. The findings of the glucose and lipid lowering or liver protective effects of SB powder have been supported by another group in Australia in high fat fed rats. Preliminary studies by the investigators in 20 healthy subjects demonstrated that dried whole SB (40 g/day for 10 weeks) significantly reduced fasting plasma glucose, total and LDL-cholesterol, systolic blood pressure, and increased plasma glucagon-like peptide compared to baseline, which was associated with increased intake of total fiber and decreased intake of saturated fat. The changes in metabolic and vascular variables significantly correlated with the alterations in gut microbiota The combination of findings suggest that SB is good candidate of prebiotic functional food as a supplemental remedy for reducing the risk for metabolic syndrome and preventing or managing T2D. The effect of Saskatoon berry and its products on metabolic disorders have not been studied in diabetic subjects. The investigators propose to examine the effects of oral administration of freeze-dried whole SB on glucose metabolism, insulin resistance and gut microbiota in untreated prediabetes and new type 2 diabetic patients compared to a control dried fruit in a randomized controlled trial.

Waitlist Available
Dietary Supplement

Faculty of Health Sciences

Image of Columbia University in New York, United States.

MediBeacon Transdermal GFR System for Heart Failure

18+
All Sexes
New York, NY

The goal of this clinical trial is to evaluate the accuracy and feasibility of transdermal glomerular filtration rate (tGFR) assessment using relmapirazin (Lumitrace) and the MediBeacon tGFR system compared to plasma clearance measurement of GFR in adults with heart failure. The main question it aims to answer is the comparison of the transdermal-derived GFR for each participant using the MediBeacon tGFR to their nGFRBSA measurement. Participants will participate in a Screening visit that will take place within 15 days of the scheduled administration of Lumitrace and iohexol. On dosing day, participants will have the tGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon Transdermal GFR System initiated to collect background fluorescence. Following an injection of Lumitrace and iohexol and the initiation of GFR assessments, participants will be followed at the study center for 10-24 hours. All participants will participate in a follow-up phone call approximately 7 days after the last exposure to Lumitrace and iohexol. Researchers will analyze the results to compare the tGFR values to the nGFRBSA measurements for each participant.

Waitlist Available
Has No Placebo

Columbia University

Richard B Dorshow, PhD

MediBeacon

Image of ProSciento, Inc. in Chula Vista, United States.

Portal Insulin U-500 for Type 1 Diabetes

18 - 60
All Sexes
Chula Vista, CA

The goal of this clinical trial is to assess the safety of a new U500 insulin formulation and to determine how rapidly it is absorbed and how long it takes to act when administered intraperitoneally. The trial will be conducted in people with Type 1 Diabetes. The main questions it aims to answer are: Is the drug safe and tolerable when administered intraperitoneally? How fast is it absorbed, and how long does it take to act? Researchers will compare the investigational product (PI-U500) with Humulin R U500 administered intraperitoneally and Lyumjev U100 administered subcutaneously. Participants will undergo a 12-hour clamp procedure in which their blood glucose will be maintained stable via glucose infusion at variable rates after a single intraperitoneal injection of the insulin formulation.

Phase 1
Recruiting

ProSciento, Inc.

Portal Diabetes, Inc.

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We made a collection of clinical trials featuring Invokamet, we think they might fit your search criteria.
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Image of Central Research Associates - Flourish - PPDS in Birmingham, United States.

CX11 for Type 2 Diabetes

18 - 75
All Sexes
Birmingham, AL

This study is testing whether a new medication called CX11 works and is safe for participants with type 2 diabetes who have not reached good blood sugar control while taking a steady dose of metformin, with or without a steady dose of an SGLT2 inhibitor, for at least 90 days. The study is being done at multiple medical centers. Participants are assigned by chance (randomized) to different groups, and neither the participants nor the study staff know which group they're in (double-blind). The groups are compared side by side (parallel), and some participants will receive inactive pills (placebo) to help measure the true effect of the study drug. After screening, participants will be randomly placed into one of six groups, with equal chances of being in any group. Each group will receive a different dose of CX11 or a placebo. Treatment will last 24 weeks. After that, all participants will have a 2-week follow-up period to check on safety.

Phase 2
Waitlist Available

Central Research Associates - Flourish - PPDS (+29 Sites)

Corxel Pharmaceuticals

Image of Mass General Brigham in Boston, United States.

Clinical Decision Support Tool for Heart Failure

18 - 85
All Sexes
Boston, MA

This study is an investigator-initiated, cluster-randomized implementation trial evaluating a large language model (LLM)-based clinical decision support (CDS) tool designed to improve guideline-directed medical therapy (GDMT) for adult patients with heart failure seen in outpatient cardiology clinics at Mass General Brigham. For eligible heart failure encounters, the CDS tool reviews existing electronic health record (EHR) data, including diagnoses, medications, vital signs, laboratory results, and recent notes, and generates brief, clinician-facing messages suggesting opportunities to initiate or optimize GDMT and highlighting relevant safety considerations. Messages are delivered to cardiology providers via Epic InBasket and/or institutional email prior to scheduled visits. The tool is advisory only and cannot place orders or change medications automatically; all treatment decisions remain at the discretion of the treating clinician and patient. Cardiology providers are assigned at the provider/clinic level to early implementation of the CDS tool versus usual care (no messages) during the initial phase. The primary outcome is GDMT optimization within 30 days of an index visit. Secondary outcomes include feasibility of CDS generation and delivery and a 30-day safety composite (e.g., heart failure hospitalization, acute kidney injury, hyperkalemia, hypotension or bradyarrhythmia plausibly related to GDMT).

Waitlist Available
Has No Placebo

Mass General Brigham

Image of International Diabetes Center in Minneapolis, United States.

Sotagliflozin for Type 1 Diabetes

18 - 75
All Sexes
Minneapolis, MN

The goal of this clinical trial is to develop and evaluate a novel diabetes ketoacidosis risk mitigation strategy to support the safe use of sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy in participants with type 1 diabetes (T1D) and mild to moderate chronic kidney disease (CKD). The main objectives of this study are to: 1. Evaluate how ketone metrics differ between participants with mild to moderate chronic kidney disease and those with normal renal function in three time periods. 2. Identify potentially modifiable ketosis risk factors. 3. Use continuous glucose monitoring (CGM) and continuous ketone monitoring (CKM) data prior to and following treatment to determine ketosis risk factors and gain knowledge to further refine reporting of risk factors. 4. Gather information on how participants and clinicians like and use the CGM/CKM reports. Participants will be asked to: * Meet with study investigators to determine if they are eligible * Sign written informed consent * Take a pregnancy test, if applicable * Have blood taken to assess kidney function and hemoglobin A1c * Take the study medication, following the study team instructions * Wear the study provided sensor throughout participation. * Complete 5 in person visits, and 11 phone check ins over a nine-month period * Provide feedback on the usefulness of CGM/CKM reports

Phase 2
Waitlist Available

International Diabetes Center

Richard Bergenstal, MD

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