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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00509262
• Other study ID #: 0431-063
• Secondary ID: 2007_549
• Status: Completed
• Phase: Phase 3
• First received: July 27, 2007
• Last updated: April 27, 2015
• Start date: October 2007
• Est. completion date: March 2011

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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
• Glipizide
Participants will receive glipizide 2.5 mg (1/2 tablet) orally once daily up to 20 mg orally daily (10 mg twice daily)
• 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
• Placebo for Glipizide
Participants will receive 1/2 tablet of placebo for glipizide orally once daily up to 2 tablets orally twice daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54	A1C represents percentage of glycosylated hemoglobin.	Baseline to Week 54	No
Primary	Percentage of Participants With Hypoglycemic Events	Percentage of participants with at least one symptomatic hypoglycemic adverse event, excluding data after initiation of glycemic rescue therapy.	Baseline up to 28 days following the last dose of study therapy	Yes
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54		Baseline to Week 54	No
Secondary	Change From Baseline in Body Weight at Week 54		Baseline to Week 54	Yes