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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014