Actoplus Met Xr

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

Treatment

22 FDA approvals

20 Active Studies for Actoplus Met Xr

What is Actoplus Met Xr

Metformin

The Generic name of this drug

Treatment Summary

Pioglitazone is a medication used to treat type 2 diabetes. It is often taken in combination with diet, exercise, and other diabetes medications. This drug works by increasing the body's sensitivity to insulin and helping to lower blood sugar levels. It is part of a class of drugs called thiazolidinediones, which also includes rosiglitazone and troglitazone. Although pioglitazone can be effective, it has been linked to side effects such as congestive heart failure and bladder cancer, so it is not as widely used as other treatments for type 2 diabetes.

Metformin Hydrochloride

is the brand name

image of different drug pills on a surface

Actoplus Met Xr 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 Type 2 Diabetes Mellitus .

Heart Failure

Used to treat Heart Failure in combination with Dapagliflozin

Type 2 Diabetes Mellitus

Used to treat Type 2 Diabetes Mellitus 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

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

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 Actoplus Met Xr Affects Patients

Pioglitazone helps your body respond better to insulin, allowing it to better manage glucose. This can help lower your blood glucose, insulin, and HbA1c levels. However, taking this medication can cause fluid retention and make existing heart failure worse, so it should not be used in those with heart failure or those at risk of developing heart failure. Additionally, there is evidence that pioglitazone may increase the risk of bladder cancer, so it should not be used in those with active bladder cancer and should be used with caution in those with a history of bladder cancer.

How Actoplus Met Xr works in the body

Pioglitazone helps make the body more sensitive to insulin, which helps lower blood sugar levels. It does this by activating PPAR-gamma, a protein in the body that helps control glucose and lipid production. This increases the body's response to insulin and decreases the amount of glucose produced by the liver. This helps with insulin resistance, a condition associated with type 2 diabetes.

When to interrupt dosage

The recommended measure of Actoplus Met Xr is contingent upon the identified condition, such as Diet, Physical Activity and Type 2 Diabetes. The quantity of dosage is contingent upon the mode of delivery (e.g. Tablet, film coated or Tablet, film coated - Oral) featured in the table underneath.

Condition

Dosage

Administration

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

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

Warnings

Actoplus Met Xr 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 Actoplus Met Xr.

Common Actoplus Met Xr 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.

Actoplus Met Xr Toxicity & Overdose Risk

In mice, the lowest toxic dose of pioglitazone is 24mg/kg over a period of 4 days and in rats 3mg/kg over 6 days. In one instance of overdose, a patient ingested 120mg for 4 days and 180mg for 7 days without any reported adverse symptoms. In case of overdose, medical professionals should provide supportive care according to the patient's condition.

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

Actoplus Met Xr Novel Uses: Which Conditions Have a Clinical Trial Featuring Actoplus Met Xr?

300 active clinical trials are being conducted to assess the utility of Actoplus Met XR in managing Type 2 Diabetes, Type 2 Diabetes Mellitus and Physical Activity.

Condition

Clinical Trials

Trial Phases

Chronic Kidney Disease

97 Actively Recruiting

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

Cardiovascular Diseases

0 Actively Recruiting

Congestive Heart Failure

178 Actively Recruiting

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

Type 1 Diabetes

112 Actively Recruiting

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

Cardiovascular Disease

25 Actively Recruiting

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

Type 2 Diabetes

162 Actively Recruiting

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

Kidney Failure

39 Actively Recruiting

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

Physical Activity

25 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

Actoplus Met Xr Reviews: What are patients saying about Actoplus Met Xr?

4.7

Patient Review

10/20/2010

Actoplus Met Xr for Type 2 Diabetes Mellitus

4

Patient Review

3/8/2012

Actoplus Met Xr for Type 2 Diabetes Mellitus

The price is unfortunately quite high.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about actoplus met xr

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

What type of drug is Actoplus Met?

"Actoplus MET is a prescription drug used to treat the symptoms of type 2 diabetes mellitus. It may be used alone or with other medications. It belongs to a class of drugs called antidiabetics and biguanides/thiazolidinediones. It is not known if it is safe and effective in children."

Answered by AI

What is the generic name for Actoplus Met?

"The drug Actos is available in both brand-name and generic form, with the latter being called pioglitazone. A generic drug is an exact replica of the active ingredient in a brand-name medication."

Answered by AI

What is Actoplus Met used for?

"Actoplus Met is a combination of two oral diabetes medicines, metformin and pioglitazone, that help control blood sugar levels. It is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus who do not use daily insulin injections."

Answered by AI

Is Actoplus Met XR discontinued?

"The ActoPlus Met XR brand will no longer be available in the United States. If the Food and Drug Administration has approved generic versions of this product, there may be generic equivalents available."

Answered by AI

Clinical Trials for Actoplus Met Xr

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. Our previous studies 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. Our preliminary studies 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. We 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
New This Month

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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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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Image of Seaway Valley Community Health Centre (Cardiac Rehab Program) in Cornwall, Canada.

FRAME for Heart Failure

18+
All Sexes
Cornwall, Canada

Heart failure is a high-risk, chronic condition that impacts patients' mental health. Approximately 50% of heart failure patients experience comorbid mental health conditions, such as stress, depression and anxiety, which affect their day-to-day lives. Despite this interconnection, the integration of mental health awareness and support into cardiac care remains limited. To address this gap, the FRAME (Foundation, Recognition, Awareness, Management, Engagement) intervention was co-designed by researchers, healthcare providers, health system decisionmakers, and patient partners. This pilot study evaluates the feasibility of implementing the FRAME intervention in pilot clinical sites within two health regions in Ontario, Canada, including team-based family medicine clinics, cardiac rehabilitation/specialist clinics, and emergency departments. Utilizing a pretest-posttest hybrid 1 model intervention design, this study evaluates process indicators and patient-focused outcomes through surveys and semi-structured qualitative interviews. Findings from this study will inform a future large scale cohort study and scalable integration of the FRAME tool into existing cardiac care pathways to enhance mental health awareness and support among heart failure patients.

Recruiting
Has No Placebo

Seaway Valley Community Health Centre (Cardiac Rehab Program) (+8 Sites)

Image of Kaiser Permanente Northern California (KPNC) in Pleasanton, United States.

Deprescribing Beta-Blockers for Diastolic Heart Failure

18+
All Sexes
Pleasanton, CA

The goal of this study is to learn whether stopping beta-blockers can help older adults with heart failure with preserved ejection fraction (HFpEF) feel better and function better. This study will test whether "deprescribing" or stopping these medications in a careful, guided way can improve symptoms and quality of life. Participants will be randomly assigned to one of two groups: Deprescribing group: Beta-blockers are gradually reduced using capsules that contain decreasing doses. Usual care group: Beta-blockers are continued at the usual dose in look-alike capsules. All participants will: * Take study medicine for about 4 months * Have their blood pressure and heart rate monitored * Complete regular phone calls and questionnaires about how they are feeling This study does not involve any experimental medication. Participants active involvement in the study will last approximately 4 months. During these 4 months they will have 8 scheduled telephone visits.

Phase 4
Waitlist Available

Kaiser Permanente Northern California (KPNC)

Parag Goyal, MD, MSc

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