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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 24

Change 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

Page last updated: August 23, 2015

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