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Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128)

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 (Drug); Comparator: Placebo (Drug); Pioglitazone (Drug); Metformin (Drug); Glipizide (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

This study will examine the safety and efficacy of the addition of sitagliptin (MK-0431) compared to placebo in patients with type 2 diabetes mellitus with inadequate glycemic control who are taking pioglitazone and metformin.

Clinical Details

Official title: A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Sitagliptin (MK-0431) in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Metformin and Pioglitazone

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 Hemoglobin A1c (A1C) at Week 26

Secondary outcome:

Change From Baseline in 2-Hour Post-Meal Glucose (PMG) at Week 26

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

Eligibility

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

Criteria:

Inclusion Criteria:

- has type 2 diabetes and is at least 18 years of age and no older than 78 years of age

- is male or is a female who is unlikely to conceive children

- is on stable doses of a peroxisome proliferator-activated receptor gamma agonist and

metformin OR metformin and a sulfonylurea agent Exclusion Criteria:

- has type 1 diabetes

- has taken a dipeptidyl peptidase (DPP-4) inhibitor or a glucagon-like peptide-1

(GLP-1) analogue

- is on a weight loss program that is not in the maintenance phase or has started a

weight loss medication within 8 weeks of screening

- has had surgery within 30 days of screening or has major surgery planned during the

study

- is on or is likely to require treatment with corticosteroids for more than 2 weeks

- has a history of active liver disease, including hepatitis B or C, cirrhosis, or

gallbladder disease

- is human immunodeficiency virus (HIV) positive

- has congestive heart failure, or has had new or worsening symptoms of coronary heart

disease within 3 months prior to screening

- has had acute coronary syndrome, coronary artery intervention, or stroke within 3

months of screening

- has severe active peripheral vascular disease

- has a history of cancer or blood disorder

- is pregnant or breast feeding

Locations and Contacts

Additional Information

Starting date: April 2009
Last updated: July 27, 2015

Page last updated: August 23, 2015

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