Predictive Parameters for Efficacy of Sitagliptin and Metformin Combination

NCT ID: NCT00969566

Last Updated: 2012-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-07-31

Brief 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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metformin+Sitagliptin

Initial combination of metformin and sitagliptin

Group Type: EXPERIMENTAL

sitagliptin, metformin

Intervention Type: DRUG

sitagliptin 100mg once daily and metformin 500mg twice daily, orally, for 24 weeks.

Interventions

sitagliptin, metformin

sitagliptin 100mg once daily and metformin 500mg twice daily, orally, for 24 weeks.

Intervention Type: DRUG

Other Intervention Names

Januvia

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Soo Lim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Soo Lim, MD, MPH, PHD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

SNUBH_ENDO1

Identifier Type: -

Identifier Source: org_study_id