Status:
COMPLETED
Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-78 years
Phase:
PHASE3
Brief 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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 15 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2010
Estimated Enrollment :
313 Patients enrolled
Trial Details
Trial ID
NCT00885352
Start Date
April 15 2009
End Date
November 10 2010
Last Update
May 23 2017
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