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A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 Diabetes (0431-068)(COMPLETED)

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: Comparator: sitagliptin phosphate (sitagliptin) (Drug); sitagliptin phosphate (+) metformin hydrochloride (Drug); Comparator: pioglitazone (Drug); Matching placebo to pioglitazone (Drug); Matching placebo to sitagliptin (Drug); Matching Placebo to Sita/Met FDC (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

The purpose of this study is to evaluate the efficacy and safety of sitagliptin and MK0431A in comparison to a commonly used medication in patients with type 2 diabetes.

Clinical Details

Official title: A Phase III Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to Study the Efficacy and Safety of Sitagliptin and MK0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Patients With Type 2 Diabetes Mellitus

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Change in Hemoglobin A1c (A1C) in the Sita/Met Fixed-Dose Combination (FDC) or Pioglitazone Groups at 40 Weeks

Change in Hemoglobin A1c (A1C) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks

Secondary outcome:

Change in 2-hour Postprandial Glucose (PMG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks

Change in 2-hour Postprandial Glucose (PMG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks

Change in Fasting Plasma Glucose (FPG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks

Change in Fasting Plasma Glucose (FPG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks

Eligibility

Minimum age: 18 Years. Maximum age: 78 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients between the ages of 18 and 78 with type 2 diabetes mellitus

- Patient has not been on any antihyperglycemic agent (Insulin or oral) in the last 3

months Exclusion Criteria:

- Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis

- Patient has previously been treated with sitagliptin or has previously been in a

study using a DPP-4 inhibitor

Locations and Contacts

Additional Information

MedWatch - FDA maintained medical product safety Information

Merck: Patient & Caregiver U.S. Product Web Site

Starting date: January 2008
Last updated: May 4, 2015

Page last updated: August 23, 2015

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