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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 16, 2011

Interventions

  • 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
  • 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)
  • 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
  • Drug: Placebo for Glipizide
    • Participants will receive 1/2 tablet of placebo for glipizide orally once daily up to 2 tablets orally twice daily

Arms, Groups and Cohorts

  • Experimental: Sitagliptin
    • Sitagliptin + Placebo for Glipizide
  • Active Comparator: Glipizide
    • Glipizide + Placebo for Sitagliptin

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54
    • Time Frame: Baseline to Week 54
    • 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
    • Percentage of participants with at least one symptomatic hypoglycemic adverse event, excluding data after initiation of glycemic rescue therapy.

Secondary Measures

  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54
    • Time Frame: Baseline to Week 54
  • Change From Baseline in Body Weight at Week 54
    • Time Frame: Baseline to Week 54

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme Corp.
  • Provider of Information About this Clinical Study
    • Sponsor

Citations Reporting on Results

Arjona Ferreira JC, Marre M, Barzilai N, Guo H, Golm GT, Sisk CM, Kaufman KD, Goldstein BJ. Efficacy and safety of sitagliptin versus glipizide in patients with type 2 diabetes and moderate-to-severe chronic renal insufficiency. Diabetes Care. 2013 May;36(5):1067-73. doi: 10.2337/dc12-1365. Epub 2012 Dec 17.

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