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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT00969566
First received: August 31, 2009
Last updated: January 5, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention Phase
Diabetes
 Drug: sitagliptin, metformin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • The change of HbA1c [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Fasting Plasma Glucose (FPG) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Postprandial Plasma Glucose (PPG) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • C-peptide [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Glucagon [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Homeostatic model assessment of insulin resistance (HOMA-IR) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: January 2009
Study Completion Date: July 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969566

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

No publications provided

Responsible Party: Soo Lim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT00969566     History of Changes
Other Study ID Numbers: SNUBH_ENDO1
Study First Received: August 31, 2009
Last Updated: January 5, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Bundang Hospital:
Diabetes
Sitagliptin
C-peptide
Glucagon

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Metformin
Hypoglycemic Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013