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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Sitagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014