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An Investigational Drug in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00095056
First received: October 29, 2004
Last updated: June 22, 2010
Last verified: June 2010
History of Changes

October 29, 2004
June 22, 2010
December 2004
July 2006   (final data collection date for primary outcome measure)
Safety and Tolerability of Sitagliptin After 12 Weeks of Treatment [ Time Frame: Week 0 through Week 12 ] [ Designated as safety issue: Yes ]
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.
Not Provided
Complete list of historical versions of study NCT00095056 on ClinicalTrials.gov Archive Site
Safety and Tolerability of Sitagliptin Over 54 Weeks [ Time Frame: Week 0 through Week 54 ] [ Designated as safety issue: Yes ]
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.
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An Investigational Drug in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency
Sitagliptin Study in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency

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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 2
  • Chronic Renal Insufficiency
  • 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: 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.
    Other Name: glipizide
  • 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.
  • Experimental: Sitagliptin
    Participants in the Sitagliptin treatment sequence will receive sitagliptin in Phase A and placebo to glipizide in Phase B.
    Interventions:
    • Drug: sitagliptin
    • Drug: glipizide
    • Drug: Placebo to glipizide
  • Placebo Comparator: Placebo
    Participants in the Placebo treatment sequence will receive placebo to sitagliptin in Phase A and glipizide in Phase B.
    Interventions:
    • Drug: Placebo to Sitagliptin
    • Drug: glipizide
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. Epub 2008 Jun 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
91
July 2006
July 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00095056
2004_054, MK0431-028
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP