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

NCT00509262 | Completed Phase 3 Results DMC

• 2 other identifiers: 0431-0632007_549
• Study Type: interventional
• Target: 426
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54

  A1C represents percentage of glycosylated hemoglobin.

  Baseline to Week 54

• 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

Secondary Outcomes (2)

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54

  Baseline to Week 54

• Change From Baseline in Body Weight at Week 54

  Baseline to Week 54

Study Arms (2)

Sitagliptin

EXPERIMENTAL

Sitagliptin + Placebo for Glipizide

Drug: Sitagliptin; Drug: Placebo for Glipizide

Glipizide

ACTIVE COMPARATOR

Glipizide + Placebo for Sitagliptin

Drug: Glipizide; Drug: Placebo for Sitagliptin

Interventions

Sitagliptin DRUG

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

Also known as: MK-0431, Januvia

Sitagliptin

Glipizide DRUG

Participants will receive glipizide 2.5 mg (1/2 tablet) orally once daily up to 20 mg orally daily (10 mg twice daily)

Also known as: Glucotrol

Glipizide

Placebo for Sitagliptin DRUG

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

Glipizide

Placebo for Glipizide DRUG

Participants will receive 1/2 tablet of placebo for glipizide orally once daily up to 2 tablets orally twice daily

Sitagliptin

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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(5):1067-73. doi: 10.2337/dc12-1365. Epub 2012 Dec 17.

  PMID: 23248197 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Interventions

Sitagliptin Phosphate; Glipizide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Sulfonylurea Compounds; Sulfones; Sulfur Compounds; Organic Chemicals

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2007
• First Posted: July 31, 2007
• Study Start: October 9, 2007
• Primary Completion: March 16, 2011
• Study Completion: March 16, 2011
• Last Updated: May 12, 2017
• Results First Posted: March 28, 2012

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share