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

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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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 1 patient group

Metformin+Sitagliptin
Experimental group
Description:
Initial combination of metformin and sitagliptin
Treatment:
Drug: sitagliptin, metformin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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