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

March 12, 2015 updated by: Merck Sharp & Dohme LLC

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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: 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 0 through Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 0 through Week 54

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (ACTUAL)

July 1, 2006

Study Completion (ACTUAL)

July 1, 2006

Study Registration Dates

First Submitted

October 29, 2004

First Submitted That Met QC Criteria

October 29, 2004

First Posted (ESTIMATE)

November 1, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

April 2, 2015

Last Update Submitted That Met QC Criteria

March 12, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0431-028
  • 2004_054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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