Overview

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