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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:
ClinicalTrials.gov Identifier:
NCT00701090
First Posted: June 19, 2008
Last Update Posted: March 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
June 17, 2008
June 19, 2008
September 13, 2010
October 5, 2010
March 10, 2017
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 ]
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 ]
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 ]
    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 ]
  • Change From Baseline in Body Weight at Week 30 [ Time Frame: Week 0 to Week 30 ]
    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 ]
  • Percent of Patients With A1C <6.5% at Week 30 [ Time Frame: Week 30 ]
to assess the change from baseline fasting plasma glucose and number of hypoglycemic episodes. [ Time Frame: 30 weeks ]
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

*   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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Austria,   Brazil,   Chile,   Colombia,   Costa Rica,   Denmark,   Ecuador,   France,   Germany,   Guatemala,   India,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   New Zealand,   Panama,   Peru,   Poland,   Spain,   Switzerland,   United Kingdom
 
NCT00701090
0431-803
2008_503
Not Provided
Not Provided
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
January 2017

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