Predictive Parameters for Efficacy of Sitagliptin and Metformin Combination

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

It is well established that inhibition of dipeptidyl peptidase (DPP)-IV reduces glucose levels in both fasting and postprandial states and preserves pancreatic beta cell function in patients with type 2 diabetes. Their mechanism of action is derived from increased incretin (GLP-1) levels, which stimulate insulin secretion as well as insulin biosynthesis and inhibit glucagon secretion from pancreas. Recent studies reported that combination therapy with DPP-IV inhibitors and metformin have additive or synergistic effects in lowering glycose level, preserving beta-cell mass and function as well as enhancing insulin sensitivity. However, there have been few studies about the difference of glucose lowering effect of combination therapy of DPP-IV inhibitors and metformin according to the secretory capacity of pancreas.

The researchers hypothesized that combination therapy with DPP-IV inhibitor and metformin may have more favorable glucose lowering effect in type 2 diabetic patients who have preserved pancreatic secretory function. The researchers plan to investigate the difference of glucose lowering effect of 24 weeks treatment with sitagliptin (DPP-IV inhibitor) in combination with metformin according to basal c-peptide and glucagon level in type 2 diabetic patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Bundang Hospital
• Treatments: Metformin; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• Type 2 diabetes

• HbA1c ≥ 7%

• Age ≥ 18

Exclusion Criteria:

• Contraindication to sitagliptin or metformin

• Pregnant or breast feeding women

• Reproductive-age women who refuse contraception

• Type 1 diabetes, gestational diabetes, or diabetes with secondary cause

• Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT > 3-fold the upper limit of normal)

• Renal failure (Cr > 2.0)

• Cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment)

• Not appropriate for oral antidiabetic agent

• Medication which affect glycemic control

• Disease which affect efficacy and safety of drugs

• Other clinical trial within 30 days