Predictive Parameters for Efficacy of Sitagliptin and Metformin Combination (COSMETIC)

Seoul National University

Status and phase

Completed

Phase 4

Conditions

Diabetes

Treatments

Drug: sitagliptin, metformin

Study type

Interventional

Funder types

Other

Identifiers

NCT00969566

SNUBH_ENDO1

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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