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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00969566
Recruitment Status : Completed
First Posted : September 1, 2009
Last Update Posted : January 6, 2012
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetes Drug: sitagliptin, metformin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Predictive Parameters for Therapeutic Efficacy of Initial Combination Therapy With Sitagliptin and Metformin in Type 2 Diabetic Patients
Study Start Date : January 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics

Arm Intervention/treatment
Experimental: Metformin+Sitagliptin
Initial combination of metformin and sitagliptin
Drug: sitagliptin, metformin
sitagliptin 100mg once daily and metformin 500mg twice daily, orally, for 24 weeks.
Other Name: Januvia

Primary Outcome Measures :
  1. The change of HbA1c [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00969566

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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
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Principal Investigator: Soo Lim, MD, MPH, PHD Seoul National University Bundang Hospital

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Responsible Party: Soo Lim, Professor, Seoul National University Bundang Hospital Identifier: NCT00969566     History of Changes
Other Study ID Numbers: SNUBH_ENDO1
First Posted: September 1, 2009    Key Record Dates
Last Update Posted: January 6, 2012
Last Verified: January 2012
Keywords provided by Soo Lim, Seoul National University Bundang Hospital:
Additional relevant MeSH terms:
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Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action