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

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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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

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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

Resource links provided by the National Library of Medicine


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.




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095056


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Publications:
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00095056     History of Changes
Other Study ID Numbers: 0431-028
2004_054
First Posted: November 1, 2004    Key Record Dates
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:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Renal Insufficiency, Chronic
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