Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00509262
First received: July 27, 2007
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in participants with moderate or severe renal insufficiency.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Renal Insufficiency, Chronic
Drug: Sitagliptin
Drug: Glipizide
Drug: Placebo for Sitagliptin
Drug: Placebo for Glipizide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency 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 Hemoglobin A1c (A1C) Levels at Week 54 [ Time Frame: Baseline to Week 54 ] [ Designated as safety issue: No ]
    A1C represents percentage of glycosylated hemoglobin.

  • Percentage of Participants With Hypoglycemic Events [ Time Frame: Baseline up to 28 days following the last dose of study therapy ] [ Designated as safety issue: Yes ]
    Percentage of participants with at least one symptomatic hypoglycemic adverse event, excluding data after initiation of glycemic rescue therapy.


Secondary Outcome Measures:
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54 [ Time Frame: Baseline to Week 54 ] [ Designated as safety issue: No ]
  • Change From Baseline in Body Weight at Week 54 [ Time Frame: Baseline to Week 54 ] [ Designated as safety issue: Yes ]

Enrollment: 426
Study Start Date: October 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin
Sitagliptin + Placebo for Glipizide
Drug: Sitagliptin
Participants with moderate renal insufficiency will receive two sitagliptin 25 mg tablets orally daily; participants with severe renal insufficiency will receive one sitagliptin 25 mg tablet orally daily
Other Names:
  • MK-0431
  • Januvia
Drug: Placebo for Glipizide
Participants will receive 1/2 tablet of placebo for glipizide orally once daily up to 2 tablets orally twice daily
Active Comparator: Glipizide
Glipizide + Placebo for Sitagliptin
Drug: Glipizide
Participants will receive glipizide 2.5 mg (1/2 tablet) orally once daily up to 20 mg orally daily (10 mg twice daily)
Other Name: Glucotrol
Drug: Placebo for Sitagliptin
Participants with moderate renal insufficiency will receive 2 placebo for sitagliptin tablets orally daily; participants with severe renal insufficiency will receive 1 placebo for sitagliptin tablet orally daily

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has type 2 diabetes mellitus
  • Has moderate or severe renal insufficiency

Exclusion Criteria:

  • Has type 1 diabetes mellitus or a history of ketoacidosis
  • Is on a new weight loss program
  • Has active liver disease
  • Is on dialysis or is likely to need dialysis during the study
  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.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00509262     History of Changes
Other Study ID Numbers: 0431-063, 2007_549
Study First Received: July 27, 2007
Results First Received: February 28, 2012
Last Updated: March 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Sitagliptin
Glipizide
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 18, 2014