Sitagliptin Added-on to Insulin Study (0431-051)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: sitagliptin phosphate (Drug); Comparator : placebo (unspecified) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2
Diabetes Mellitus who have inadequate glycemic control on insulin or insulin/metformin
combination therapy.
Clinical Details
Official title: A Phase III, Multicenter, Randomized, Double-Blind Clinical Trial to Study the Safety and Efficacy of the Addition of Sitagliptin (MK0431) to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Insulin Therapy (Alone or In Combination With Metformin)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change From Baseline in A1C at Week 24
Secondary outcome: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24 Percent Change From Baseline in Index of Static Beta-Cell Sensitivity to Glucose at Week 24 Percent of Patients With A1C < 7.0% at Week 24 Percent of Patients With A1C < 6.5% at Week 24
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient has type 2 diabetes mellitus
- Patient is poorly controlled while on insulin or insulin and metformin
Exclusion Criteria:
- Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
- Patient is taking oral antidiabetic agents other than metformin during the past 3
months
- Patient is currently on treatment with daily use of pre-prandial short-acting or
rapid-acting insulin
Locations and Contacts
Additional Information
(MedWatch - FDA maintained medical product safety Information) (Merck: Patient & Caregiver U.S. Product Web Site)
Starting date: December 2006
Last updated: April 24, 2015
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