An Investigational Drug in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (0431-028)(COMPLETED)

• ClinicalTrials.gov Identifier: NCT00095056
• Recruitment Status: Completed
• First Posted: November 1, 2004
• Results First Posted: July 23, 2010
• Last Update Posted: April 2, 2015
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Study Description

Brief Summary:

The purpose of this study is to determine the safety and tolerability of an investigational drug in patients with Type 2 Diabetes Mellitus (a specific type of diabetes) and Chronic Renal Insufficiency (inadequate kidney function).

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2; Chronic Renal Insufficiency	Drug: sitagliptin; Drug: Placebo to Sitagliptin; Drug: glipizide; Drug: Placebo to glipizide	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 91 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Sitagliptin Study in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency
• Study Start Date: October 2004
• Actual Primary Completion Date: July 2006
• Actual Study Completion Date: July 2006

Arms and Interventions

Arm	Intervention/treatment
Experimental: Sitagliptin; Participants in the Sitagliptin treatment sequence will receive sitagliptin in Phase A and placebo to glipizide in Phase B.	Drug: sitagliptin; One (participants with visit 1 estimated creatinine clearance <30 mL/min or undergo regular dialysis) or Two (participants with visit 1 creatinine clearance of =30 to <50 mL/min; not on dialysis) tablets of 25 mg Sitagliptin daily.; Other Name: MK0431; Drug: glipizide; One 5 mg glipizide tablet per day. The dose of glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations.; Drug: Placebo to glipizide; One placebo to glipizide 5 mg tablet per day. The dose of placebo to glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations.
Placebo Comparator: Placebo; Participants in the Placebo treatment sequence will receive placebo to sitagliptin in Phase A and glipizide in Phase B.	Drug: Placebo to Sitagliptin; One (participants with visit 1 estimated creatinine clearance <30 mL/min or undergo regular dialysis) or Two (participants with visit 1 creatinine clearance of =30 to <50 mL/min and not on dialysis) tablets of placebo to sitagliptin 25 mg daily.; Drug: glipizide; One 5 mg glipizide tablet per day. The dose of glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations.

Outcome Measures

Primary Outcome Measures :

1. Safety and Tolerability of Sitagliptin After 12 Weeks of Treatment [ Time Frame: Week 0 through Week 12 ]
   Safety and tolerability were measured in terms of the number of patients with clinical adverse experiences (CAEs), serious CAEs, drug-related CAEs, laboratory adverse experiences (LAEs), serious LAEs, and drug-related LAEs. Drug-relationship was assessed by the study investigator according to his/her best clinical judgment.

Secondary Outcome Measures :

1. Safety and Tolerability of Sitagliptin Over 54 Weeks [ Time Frame: Week 0 through Week 54 ]
   Safety and tolerability were measured in terms of the number of patients with clinical adverse experiences (CAEs), serious CAEs, drug-related CAEs, laboratory adverse experiences (LAEs), serious LAEs, and drug-related LAEs. Drug-relationship was assessed by the study investigator according to his/her best clinical judgment.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients who are at least 18 years of age diagnosed with type 2 diabetes mellitus (T2DM) (a specific type of diabetes).
• Patient has renal (kidney) insufficiency (inadequate kidney function)

Exclusion Criteria:

• Patient has had heart problems (such as a heart attack or chest pain) or stroke within the past 6 months or any condition or therapy which, in the opinion of the investigator, may not be in the patient's best interest to participate.
• Pregnant or breast feeding

Contacts and Locations

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme Corp.

More Information

Publications:

Chan JC, Scott R, Arjona Ferreira JC, Sheng D, Gonzalez E, Davies MJ, Stein PP, Kaufman KD, Amatruda JM, Williams-Herman D. Safety and efficacy of sitagliptin in patients with type 2 diabetes and chronic renal insufficiency. Diabetes Obes Metab. 2008 Jul;10(7):545-55. doi: 10.1111/j.1463-1326.2008.00914.x. Epub 2008 Jun 1.

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT00095056
• Other Study ID Numbers: 0431-028; 2004_054
• First Posted: November 1, 2004
• Results First Posted: July 23, 2010
• Last Update Posted: April 2, 2015
• Last Verified: March 2015

Keywords provided by Merck Sharp & Dohme Corp.:

Type 2 Diabetes Mellitus and Chronic Renal Insufficiency

Additional relevant MeSH terms:

Renal Insufficiency; Renal Insufficiency, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Sitagliptin Phosphate; Glipizide; Hypoglycemic Agents; Physiological Effects of Drugs; Incretins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dipeptidyl-Peptidase IV Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action