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
  Purpose

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).


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily)
Drug: Comparator: MK0431 100 mg q.d. (q.d. = once daily)
Drug: Comparator: Placebo (Phase A)/Metformin (Phase B)
Drug: Comparator: Metformin 500 mg b.i.d.
Drug: Comparator: Open-Label MK0431/Metformin 50/1000 mg b.i.d.
Drug: Comparator: Metformin 1000 mg b.i.d.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 1208
Study Start Date: March 2005
Study Completion Date: February 2008
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MK0431 100 mg q.d.
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.
Active Comparator: 2
Metformin 500 mg b.i.d.
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.
Active Comparator: 3
Metformin 1000 mg b.i.d.
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: 4
Coadministration of MK0431 and Metformin 50/500 mg b.i.d.
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: 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.
Experimental: 5
Coadministration of MK0431 and Metformin 50/1000 mg b.i.d.
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: 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.
Placebo Comparator: 6
Placebo/Metformin 1000 mg b.i.d.
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.
Experimental: 7
Non-Randomized, Open-Label: Coadministration MK0431 and Metformin 50/1000 mg b.i.d.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103857

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: NCT00103857     History of Changes
Other Study ID Numbers: 0431-036, MK0431-036, 2005_003
Study First Received: February 15, 2005
Results First Received: February 19, 2009
Last Updated: November 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014