Sitagliptin Metformin/PPARg Agonist Combination Therapy Add-on (0431-052)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00350779
First received: July 7, 2006
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin/peroxisome proliferator-activated receptor gamma (PPARg) agonist combination therapy.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: sitagliptin
Drug: Comparator: Placebo
Drug: rosiglitazone
Drug: metformin
Drug: glipizide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Sitagliptin (MK0431) in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Metformin and a PPARg Agonist

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 18 [ Time Frame: Baseline and 18 Weeks ] [ Designated as safety issue: No ]
    HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent.


Secondary Outcome Measures:
  • Change From Baseline in FPG (Fasting Plasma Glucose) at Week 18 [ Time Frame: Baseline and 18 Weeks ] [ Designated as safety issue: No ]
    Change from baseline at Week 18 is defined as Week 18 minus Week 0

  • Change From Baseline in 2-hour PMG (Post-meal Glucose) at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
    Change from baseline at Week 18 is defined as Week 18 minus Week 0

  • Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
    HbA1c is measured as a percent. Thus, 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: Baseline and 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: Baseline and Week 54 ] [ Designated as safety issue: No ]
    Change from baseline at Week 54 is defined as Week 54 minus Week 0.


Enrollment: 262
Study Start Date: June 2006
Study Completion Date: June 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Sitagliptin
Drug: sitagliptin
Sitagliptin 100mg tablet each day for 54 weeks. All subjects will be given placebo to sitagliptin for a 2 week period.
Other Name: Januvia
Drug: rosiglitazone
Subjects taking 4mg or greater rosiglitazone at screening will enter a 6 week stable dose period followed by a 54 week treatment period. Subjects who are taking less than 4mg/day or no rosiglitazone at screening will be titrated to a stable dose of at least 4mg over a a maximum of 8 weeks followed by a dose stable period of up to 12 weeks then a 54 week treatment period. Total treatment will be up to 77 weeks.
Other Name: Avandia
Drug: metformin
Subjects taking 1500mg or greater metformin at screening will enter a 6 week stable dose period followed by a 54 week treatment period. Subjects who are taking less than 1500mg/day or no metformin at screening will be titrated to a stable dose of at least 1500mg over a a maximum of 8 weeks followed by a dose stable period of up to 12 weeks then a 54 week treatment period. Total treatment will be up to 77 weeks.
Drug: glipizide
Subjects not meeting specific glycemic controls during the 54-week treatment period will use glipizide as rescue therapy. Glipizide will be titrated in 5mg doses up to a maximum 40mg each day. (In Canada, the rescue therapy will be a sulfonylurea agent marketed in that country.)
Other Name: Glucotrol
Placebo Comparator: 2
Placebo
Drug: Comparator: Placebo
Placebo to sitagliptin 100mg tablet each day for 54 weeks.
Drug: rosiglitazone
Subjects taking 4mg or greater rosiglitazone at screening will enter a 6 week stable dose period followed by a 54 week treatment period. Subjects who are taking less than 4mg/day or no rosiglitazone at screening will be titrated to a stable dose of at least 4mg over a a maximum of 8 weeks followed by a dose stable period of up to 12 weeks then a 54 week treatment period. Total treatment will be up to 77 weeks.
Other Name: Avandia
Drug: metformin
Subjects taking 1500mg or greater metformin at screening will enter a 6 week stable dose period followed by a 54 week treatment period. Subjects who are taking less than 1500mg/day or no metformin at screening will be titrated to a stable dose of at least 1500mg over a a maximum of 8 weeks followed by a dose stable period of up to 12 weeks then a 54 week treatment period. Total treatment will be up to 77 weeks.
Drug: glipizide
Subjects not meeting specific glycemic controls during the 54-week treatment period will use glipizide as rescue therapy. Glipizide will be titrated in 5mg doses up to a maximum 40mg each day. (In Canada, the rescue therapy will be a sulfonylurea agent marketed in that country.)
Other Name: Glucotrol

  Eligibility

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

Inclusion Criteria:

  • Patient has type 2 diabetes mellitus
  • Patient is inadequately controlled while taking two oral antidiabetic medications

Exclusion Criteria:

  • Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
  • Patient required insulin therapy within the prior 3 months
  • Patient has been taking Byetta (R) (exenatide) within the prior 3 months
  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: NCT00350779

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

Additional Information:
No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00350779     History of Changes
Other Study ID Numbers: 0431-052, MK0431-052, 2006_507
Study First Received: July 7, 2006
Results First Received: May 13, 2009
Last Updated: May 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Sitagliptin
Glipizide
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 August 21, 2014