MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00103857
First received: February 15, 2005
Last updated: November 12, 2013
Last verified: November 2013

February 15, 2005
November 12, 2013
March 2005
July 2006   (final data collection date for primary outcome measure)
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.
Not Provided
Complete list of historical versions of study NCT00103857 on ClinicalTrials.gov Archive Site
  • Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Change from baseline at Week 24 is defined as Week 24 minus Week 0.
  • Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Change from baseline at Week 24 is defined as Week 24 minus Week 0.
  • Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]
    HbA1c is measured as a percent. This change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.
  • Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]
    Change from baseline at Week 54 is defined as Week 54 minus Week 0.
  • Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]
    Change from baseline at Week 54 is defined as Week 54 minus Week 0.
  • Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104 [ Time Frame: Week 104 ] [ Designated as safety issue: No ]
    HbA1c is measured as a percent. This change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.
  • Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104 [ Time Frame: Week 104 ] [ Designated as safety issue: No ]
    Change from baseline at Week 104 is defined as Week 104 minus Week 0.
  • Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104 [ Time Frame: Week 104 ] [ Designated as safety issue: No ]
    Change from baseline at Week 104 is defined as Week 104 minus Week 0.
Not Provided
Not Provided
Not Provided
 
MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036)(COMPLETED)
A Multicenter, Randomized, Double-Blind Factorial Study of the Co-Administration of MK0431 and Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus (T2DM) (a specific type of diabetes).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily)
    MK0431 oral tablets will be started on Day 1 at 50 mg q.d. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take MK0431 50 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
    Other Name: MK0431
  • Drug: Comparator: MK0431 100 mg q.d. (q.d. = once daily)
    MK0431 oral tablets will be started on Day 1 as two 50 mg tablets (100 mg q.d.) (q.d. = once daily) and continued at this dose throughout the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
  • Drug: Comparator: Placebo (Phase A)/Metformin (Phase B)
    During the placebo-controlled period (Day 1 through Week 24/Phase A), metformin and MK0431 matching placebos will be dispensed as oral tablets. At the beginning of the 30-week active-controlled period (Phase B), metformin will be started as 500 mg q.d. (q.d. = once daily) and up-titrated in 500 mg weekly increments to a stable dose of 1000 mg b.i.d. Patients who complete the 54-week base study and who enter the 50-week extension study will continue to take metformin 1000 mg b.i.d. (b.i.d. = twice daily) for a total placebo/metformin treatment duration of up to 104 weeks.
  • Drug: Comparator: Metformin 500 mg b.i.d.
    Metformin oral tablets will be started on Day 1 at 500 mg q.d. (q.d. = once daily) and increased after 1 week to a stable dose of 500 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take metformin 500 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
  • Drug: Comparator: Open-Label MK0431/Metformin 50/1000 mg b.i.d.
    MK0431 oral tablets will be started on Day 1 at 50 mg q.d. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) Metformin oral tablets will be started on Day 1 at 500 mg q.d. and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. The open-label treatment period is 24 weeks.
  • Drug: Comparator: Metformin 1000 mg b.i.d.
    Metformin oral tablets will be started on Day 1 at 500 mg q.d. (q.d. = once daily) and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take metformin 1000 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
  • Experimental: 1
    MK0431 100 mg q.d.
    Intervention: Drug: Comparator: MK0431 100 mg q.d. (q.d. = once daily)
  • Active Comparator: 2
    Metformin 500 mg b.i.d.
    Intervention: Drug: Comparator: Metformin 500 mg b.i.d.
  • Active Comparator: 3
    Metformin 1000 mg b.i.d.
    Intervention: Drug: Comparator: Metformin 1000 mg b.i.d.
  • Experimental: 4
    Coadministration of MK0431 and Metformin 50/500 mg b.i.d.
    Interventions:
    • Drug: Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily)
    • Drug: Comparator: Metformin 500 mg b.i.d.
  • Experimental: 5
    Coadministration of MK0431 and Metformin 50/1000 mg b.i.d.
    Interventions:
    • Drug: Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily)
    • Drug: Comparator: Metformin 1000 mg b.i.d.
  • Placebo Comparator: 6
    Placebo/Metformin 1000 mg b.i.d.
    Intervention: Drug: Comparator: Placebo (Phase A)/Metformin (Phase B)
  • Experimental: 7
    Non-Randomized, Open-Label: Coadministration MK0431 and Metformin 50/1000 mg b.i.d.
    Intervention: Drug: Comparator: Open-Label MK0431/Metformin 50/1000 mg b.i.d.
Goldstein BJ, Feinglos MN, Lunceford JK, Johnson J, Williams-Herman DE. Effect of Initial Combination Therapy with Sitagliptin, a Dipeptidyl Peptidase-4 Inhibitor, and Metformin on Glycemic Control in Patients with Type 2 Diabetes. Diabetes Care. 2007 May 7; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1208
February 2008
July 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

54-Week Base Study:

  • Patients between the ages of 18 and 78 with Type 2 Diabetes Mellitus (a specific type of diabetes)

    50-Week Extension Study:

  • Patients who complete the 54-week base study are eligible to enter the 50-week extension study

Exclusion Criteria:

  • Patients who do not have Type 2 Diabetes Mellitus (a specific type of diabetes)
Both
18 Years to 78 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00103857
0431-036, MK0431-036, 2005_003
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2013

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