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
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: 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
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
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 August 21, 2014