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OpenTrials
Completed

NCT Number: NCT00969566

Predictive Parameters for Efficacy of Sitagliptin and Metformin Combination

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sitagliptin, metformin

Drug

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

Other names: Januvia

Primary outcomes

  1. The change of HbA1c

    Time frame: 52 weeks

Secondary outcomes

  1. Fasting Plasma Glucose (FPG)

    Time frame: 52 weeks

  2. Postprandial Plasma Glucose (PPG)

    Time frame: 52 weeks

  3. C-peptide

    Time frame: 52 weeks

  4. Glucagon

    Time frame: 52 weeks

  5. Homeostatic model assessment of insulin resistance (HOMA-IR)

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Predictive Parameters for Therapeutic Efficacy of Initial Combination Therapy With Sitagliptin and Metformin in Type 2 Diabetic Patients

Acronym: COSMETIC

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Sep 1, 2009
Registry last updated
Jan 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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