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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)

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ClinicalTrials.gov Identifier: NCT00701090
Recruitment Status : Completed
First Posted : June 19, 2008
Results First Posted : October 5, 2010
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 1035 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30 [ Time Frame: Week 0 to Week 30 ]
  3. 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.

  4. Percent of Patients With A1C <7.0% at Week 30 [ Time Frame: Week 30 ]
  5. Percent of Patients With A1C <6.5% at Week 30 [ Time Frame: Week 30 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00701090


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

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00701090     History of Changes
Other Study ID Numbers: 0431-803
2008_503
First Posted: June 19, 2008    Key Record Dates
Results First Posted: October 5, 2010
Last Update Posted: March 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
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


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
Metformin
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors