Overview

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

Status:
Completed
Trial end date:
2010-11-10
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Glipizide
Metformin
Pioglitazone
Sitagliptin Phosphate
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