Fortamet

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

Treatment

22 FDA approvals

20 Active Studies for Fortamet

What is Fortamet

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 has been prescribed to over 120 million people around the world. Metformin works by reducing blood sugar levels without causing low blood sugar, and it also helps to reduce insulin resistance and insulin levels. Additionally, metformin can lead to weight loss in obese type 2 diabetes patients. It was first approved for use in Canada in 1972 and in the US in 1995, and it is available in regular and extended-release forms.

Metformin Hydrochloride

is the brand name

image of different drug pills on a surface

Fortamet 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 Kidney Failure .

Heart Failure

Used to treat Heart Failure in combination with Dapagliflozin

Kidney Failure

Used to treat End Stage Renal Disease (ESRD) 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

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 Fortamet Affects Patients

Insulin is a hormone that helps keep your blood sugar levels in check. People with type 2 diabetes don't respond as well to insulin, causing their blood sugar levels to become too high. Metformin counteracts this by reducing the amount of sugar made by the liver and stopping sugar from being absorbed by the intestines. It also helps the body use insulin more effectively. In a clinical trial, people taking metformin saw their fasting plasma glucose levels decrease by an average of 59mg/dL, while those taking a placebo saw an average increase of 6.3mg/dL. The Glycosylated hemoglobin (Hb

How Fortamet works in the body

Metformin works differently than other diabetes medications. It lowers blood glucose levels by reducing how much glucose is made in the liver, stopping glucose from being absorbed in the intestines, and increasing the body’s sensitivity to insulin. It does this by entering cells and mitochondria and inhibiting the production of mitochondrial ATP, leading to an increase in AMP:ATP ratios. This activates AMPK, an enzyme that helps regulate glucose metabolism, and stops fructose-1,6-bisphosphatase from producing glucose, which helps reduce gluconeogenesis. It also decreases the production of cAMP, a derivative of ATP.

When to interrupt dosage

The prescribed dosage of Fortamet is contingent upon the identified illness, such as Diet, inadequate reaction to metformin and Diabetic Ketoacidosis. The measure of dosage is based on the system of delivery (e.g. Oral or Tablet - Oral) specified in the table beneath.

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

Warnings

Fortamet 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 Fortamet.

Common Fortamet 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.

Fortamet Toxicity & Overdose Risk

Metformin has an oral LD50 in rats of 1g/kg, an intraperitoneal LD50 of 500mg/kg in rats, and a subcutaneous LD50 of 300mg/kg in rats. The oral LD50 in mice is 1450mg/kg, the intraperitoneal LD50 is 420mg/kg, and the subcutaneous LD50 is 225mg/kg. Those taking metformin may be at risk for lactic acidosis, which is characterized by high blood lactate levels, anion gap acidosis, and increased lactate:pyruvate ratio. Risk

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

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

Currently, there are 346 active clinical trials assessing the potential of Fortamet to provide a remedy for Type 2 Diabetes, Type 1 Diabetes and inadequate responses to metformin.

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

180 Actively Recruiting

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

Type 1 Diabetes

194 Actively Recruiting

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

Cardiovascular Disease

26 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

Fortamet Reviews: What are patients saying about Fortamet?

5

Patient Review

11/22/2008

Fortamet for Type 2 Diabetes Mellitus

I just started taking this last night and was confused after reading the reviews. It seems that people have had success with Fortamet, so I'm hopeful that it will help me too.

5

Patient Review

9/23/2009

Fortamet for Type 2 Diabetes Mellitus

The medication was effective in keeping my blood sugar down, but I experienced some very unpleasant side effects like headaches, dizziness, and nausea.

5

Patient Review

2/27/2011

Fortamet for Type 2 Diabetes Mellitus

I've been using this medication for a while now, and it seems to be working. My most recent bloodwork showed that my levels have decreased, so I must be doing something right.

5

Patient Review

11/12/2010

Fortamet for Type 2 Diabetes Mellitus

I experienced hair loss and terrible acid indigestion; however, the benefits of this drug outweighed the negatives for me.

4.7

Patient Review

5/11/2009

Fortamet for Disease of Ovaries with Cysts

I've been taking Fortamet for just over a week now. I have had some diarrhea off and on, but the worst side effect has been the nasty taste it's left in my mouth. It makes food taste like old cigarette ashes.

4.7

Patient Review

10/2/2010

Fortamet for Disease of Ovaries with Cysts

I've been taking this medication for a while now to treat my PCOS. It's helped some, but I still have intermittent diarrhea. On the plus side, it doesn't interfere with my daily activities; however, I have noticed that it suppresses my appetite.

4.3

Patient Review

7/3/2011

Fortamet for Type 2 Diabetes Mellitus

So far, I'm really liking this medication better than the generic metformin. No diarrhea and it's working well for me. Fingers crossed that I'll see some weight loss and improvements in my a1c numbers.

4

Patient Review

7/7/2009

Fortamet for Disease of Ovaries with Cysts

I found that taking the entire 2000 mg dose right before bed helps me avoid nausea and diarrhea altogether.

4

Patient Review

3/2/2010

Fortamet for Type 2 Diabetes Mellitus

The first time I tried to take this pill, it nearly killed me. I had to have an IV in the ambulance on the way to the emergency room. The company said they would reimburse me, but it's been seven weeks and all they've done is give me excuses.

4

Patient Review

7/27/2010

Fortamet for Type 2 Diabetes Mellitus

I've only been taking this medication for two weeks, and the headaches have been the only side effect so far. I'm managing, but it's not ideal.

4

Patient Review

4/2/2009

Fortamet for Type 2 Diabetes Mellitus

I unfortunately got severe diarrhea from this treatment, to the point where I had to take anti-diarrhea medication. However, it did help with my ____ issue.

4

Patient Review

3/12/2010

Fortamet for Type 2 Diabetes Mellitus

Fortamet has been successful in regulating my blood sugar levels. I can't take the large 1000mg pill, so I have to split it into two 500mg doses, which is a bit of a hassle. The smell of this medication is really unpleasant-- it smells like old fish.

3.7

Patient Review

7/22/2009

Fortamet for Type 2 Diabetes Mellitus

Though large, the 1000mg pill is much easier to swallow than two 500mg metformin pills. I experienced fewer side effects with this treatment as well.

2.7

Patient Review

8/4/2010

Fortamet for Type 2 Diabetes Mellitus

I've been taking this medication for two years now, and I take it along with Byetta every day.

2.3

Patient Review

3/8/2009

Fortamet for Type 2 Diabetes Mellitus

My sugar levels have lowered since I started taking this medication, which is great. My cycles are more regular now and ovulation has improved, which is also fantastic.

1

Patient Review

11/14/2008

Fortamet for Type 2 Diabetes Mellitus

1

Patient Review

1/4/2010

Fortamet for Type 2 Diabetes Mellitus

It's the best metformin, but I can't afford it.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about fortamet

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

What is Fortamet used for?

"Metformin is a medication used to control high blood sugar. It is often used in combination with diet and exercise to control blood sugar in patients with type 2 diabetes. Controlling high blood sugar helps prevent a variety of issues including kidney damage, blindness, nerve problems, and loss of limbs."

Answered by AI

Is metformin er the same as Fortamet?

"There are a few different ER products for metformin, including Glumetza and Fortamet. They work differently by slowly releasing metformin over time. Since they don't work in the same way, Glumetza and Fortamet can't be used interchangeably."

Answered by AI

What kind of drug is Fortamet?

"Fortamet is a diabetes medication taken orally by people with type 2 diabetes. It is sometimes used in combination with insulin or other medications, but not for those with type 1 diabetes. Fortamet is available in generic form."

Answered by AI

What is the generic for Fortamet?

"Mylan has introduced metformin hydrochloride expanded-discharge tablets, the nonexclusive adaptation of Watson's Fortamet, in 500 mg and 1000 mg portions. This nonexclusive item is implied for use as an embellishment to eating routine and activity to improve glycemic control in grown-ups with type 2 diabetes mellitus."

Answered by AI

Clinical Trials for Fortamet

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
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 Fortamet, we think they might fit your search criteria.
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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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