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

June 17, 2008
March 13, 2014
May 2008
October 2009   (final data collection date for primary outcome measure)
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.
to assess the change from baseline in HbA1c glucose levels. [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00701090 on ClinicalTrials.gov Archive Site
  • 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 ]
to assess the change from baseline fasting plasma glucose and number of hypoglycemic episodes. [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus, Non Insulin Dependent.
  • Diabetes Mellitus, Non-Insulin-Dependent
  • Drug: sitagliptin
    Sitagliptin 100 mg q.d. (q.d. = once daily); Duration of Treatment: 30 weeks
    Other Name: Januvia
  • 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
  • Experimental: 1
    sitagliptin
    Interventions:
    • Drug: sitagliptin
    • Drug: open-label metformin
  • Active Comparator: 2
    glimepiride
    Interventions:
    • Drug: Comparator: glimepiride
    • Drug: open-label metformin
Arechavaleta R, Seck T, Chen Y, Krobot KJ, O'Neill EA, Duran L, Kaufman KD, Williams-Herman D, Goldstein BJ. Efficacy and safety of treatment with sitagliptin or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2011 Feb;13(2):160-8. doi: 10.1111/j.1463-1326.2010.01334.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1035
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00701090
0431-803, 2008_503
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP