Clinical trial NCT00885352: Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-04-21
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 pioglitazone and metformin.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (A1C) at Week 26
timeFrame: Baseline and Week 26
Secondary outcomes:
measure: Change From Baseline in 2-Hour Post-Meal Glucose (PMG) at Week 26
timeFrame: Baseline and Week 26
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
timeFrame: Baseline and Week 26
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Fonseca V, Staels B, Morgan JD 2nd, Shentu Y, Golm GT, Johnson-Levonas AO, Kaufman KD, Goldstein BJ, Steinberg H. Efficacy and safety of sitagliptin added to ongoing metformin and pioglitazone combination therapy in a randomized, placebo-controlled, 26-week trial in patients with type 2 diabetes. J Diabetes Complications. 2013 Mar-Apr;27(2):177-83. doi: 10.1016/j.jdiacomp.2012.09.007. Epub 2012 Oct 30.