A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00701090
First received: June 17, 2008
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

A study to see if better control of type 2 diabetes can occur in patients taking a stable dose of metformin when they are also provided either sitagliptin or glimepiride. This study will also see if this treatment is safe and tolerable.


Condition Intervention Phase
Type 2 Diabetes Mellitus, Non Insulin Dependent.
Diabetes Mellitus, Non-Insulin-Dependent
Drug: sitagliptin
Drug: Comparator: glimepiride
Drug: open-label metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin Compared With the Addition of Glimepiride in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change From Baseline in HbA1c at Week 30 [ Time Frame: Week 0 to Week 30 ] [ Designated as safety issue: No ]
    Patient-level HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the Week 0 HbA1c percent.


Secondary Outcome Measures:
  • Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30 [ Time Frame: Week 0 to Week 30 ] [ Designated as safety issue: No ]
    Change from baseline at Week 30 was defined as Week 30 minus Week 0.

  • Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30 [ Time Frame: Week 0 to Week 30 ] [ Designated as safety issue: No ]
  • Change From Baseline in Body Weight at Week 30 [ Time Frame: Week 0 to Week 30 ] [ Designated as safety issue: No ]
    Change from baseline at Week 30 was defined as Week 30 minus Week 0.

  • Percent of Patients With A1C <7.0% at Week 30 [ Time Frame: Week 30 ] [ Designated as safety issue: No ]
  • Percent of Patients With A1C <6.5% at Week 30 [ Time Frame: Week 30 ] [ Designated as safety issue: No ]

Enrollment: 1035
Study Start Date: May 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
sitagliptin
Drug: sitagliptin
Sitagliptin 100 mg q.d. (q.d. = once daily); Duration of Treatment: 30 weeks
Other Name: Januvia
Drug: open-label metformin
open-label metformin oral tablets (≥1500 mg/day) in addition to Glimepiride or Sitagliptin treatment.
Other Name: metformin
Active Comparator: 2
glimepiride
Drug: Comparator: glimepiride
glimepiride 1 mg per day to be up-titrated (up to week 18 of the double-blind treatment period) as considered appropriate by the investigator, based upon the results of patient's self blood glucose monitoring (SBGM). The maximum dose of glimepiride must not be higher than 6 mg/day.
Drug: open-label metformin
open-label metformin oral tablets (≥1500 mg/day) in addition to Glimepiride or Sitagliptin treatment.
Other Name: metformin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Diagnosed with type 2 diabetes
  • On a stable dose of metformin of at least 1500 mg per day

Exclusion Criteria:

  • History of type 1 diabetes
  • Pregnant
  • HIV positive
  • On a weight loss program or medication
  • Has a history of blood disorder, certain cancers, heart, liver or kidney disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701090

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00701090     History of Changes
Other Study ID Numbers: 0431-803, 2008_503
Study First Received: June 17, 2008
Results First Received: September 13, 2010
Last Updated: March 13, 2014
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Merck Sharp & Dohme Corp.:
Type 2 Diabetes Mellitus
Non Insulin Dependent

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Sitagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014