Last reviewed · How we verify
Glimepiride/metformin fixed combination
This combination reduces blood glucose by stimulating insulin secretion from pancreatic beta cells (glimepiride) and decreasing hepatic glucose production while improving insulin sensitivity (metformin).
This combination reduces blood glucose by stimulating insulin secretion from pancreatic beta cells (glimepiride) and decreasing hepatic glucose production while improving insulin sensitivity (metformin). Used for Type 2 diabetes mellitus.
At a glance
| Generic name | Glimepiride/metformin fixed combination |
|---|---|
| Also known as | Amaryl M |
| Sponsor | Handok Inc. |
| Drug class | Sulfonylurea/biguanide combination |
| Target | ATP-sensitive potassium channel (glimepiride); mitochondrial complex I / AMPK pathway (metformin) |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | FDA-approved |
Mechanism of action
Glimepiride is a meglitinide that binds to ATP-sensitive potassium channels on beta cells, triggering insulin release in response to glucose. Metformin is a biguanide that reduces hepatic gluconeogenesis and improves peripheral insulin sensitivity without stimulating insulin secretion. Together, they provide complementary glucose-lowering effects through different mechanisms.
Approved indications
- Type 2 diabetes mellitus
Common side effects
- Hypoglycemia
- Gastrointestinal disturbance (nausea, diarrhea, abdominal discomfort)
- Headache
- Dizziness
- Weight gain
Key clinical trials
- Glimepiride, Empagliflozin, and Sitagliptin With Metformin for Type 2 Diabetes (PHASE4)
- COMPOUND (INN): HOE490O - GLIMEPIRIDE / METFORMIN HCl (Amaryl® M)0 (Glimepiride/Metformin Hydrochloride Immediate Release Combination Tablet) in Fed Conditions in Healthy Male and/or Female Subjects. (PHASE1)
- A Study of the Efficacy and Safety of MK-0431D (a Fixed-dose Combination of Sitagliptin and Simvastatin) for the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-266) (PHASE3)
- Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (FDC) Compared to Glimepiride in Participants With Type 2 Diabetes Mellitus (MK-0431A-202) (PHASE4)
- Evaluation of Food Effect on the Pharmacokinetics of Sustained Release Metformin in Healthy Indian Volunteers (NA)
- Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Extended Release Metformin and Extended Release Glimepiride in Health Volunteers (PHASE1)
- Efficacy and Safety of the Fixed Dose Combination of Glimepiride+Metformin in Type 2 Diabetic Patients Inadequately Controlled (PHASE3)
- Evaluation of Fixed Dose Combination of Glimepiride and Metformin in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Glimepiride/metformin fixed combination CI brief — competitive landscape report
- Glimepiride/metformin fixed combination updates RSS · CI watch RSS
- Handok Inc. portfolio CI