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

NCT00095056 | Completed Phase 3 Results

• 2 other identifiers: 0431-0282004_054
• Study Type: interventional
• Target: 91
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Diabetes Mellitus, Type 2; Chronic Renal Insufficiency

Keywords

Type 2 Diabetes Mellitus and Chronic Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of Sitagliptin After 12 Weeks of Treatment

  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.

  Week 0 through Week 12

Secondary Outcomes (1)

• Safety and Tolerability of Sitagliptin Over 54 Weeks

  Week 0 through Week 54

Study Arms (2)

Sitagliptin

EXPERIMENTAL

Participants in the Sitagliptin treatment sequence will receive sitagliptin in Phase A and placebo to glipizide in Phase B.

Drug: sitagliptin; Drug: glipizide; Drug: Placebo to glipizide

Placebo

PLACEBO COMPARATOR

Participants in the Placebo treatment sequence will receive placebo to sitagliptin in Phase A and glipizide in Phase B.

Drug: Placebo to Sitagliptin; Drug: glipizide

Interventions

sitagliptin DRUG

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.

Also known as: MK0431

Sitagliptin

Placebo to Sitagliptin DRUG

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.

Placebo

glipizide DRUG

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.

Placebo; Sitagliptin

Placebo to glipizide DRUG

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.

Sitagliptin

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 18518892 BACKGROUND

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: Executive Vice President, Clinical and Quantitative Sciences
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: October 29, 2004
• First Posted: November 1, 2004
• Study Start: October 1, 2004
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: April 2, 2015
• Results First Posted: July 23, 2010

Record last verified: 2015-03