Clinical trial NCT00086502: Pioglitazone Add-on Study in Patients With Type 2 Diabetes Mellitus
Official title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Pioglitazone Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-07-05
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Patient has type 2 diabetes mellitus (T2DM)
* Patient is 18 years of age (or older)
* Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and poststudy follow-up period

Exclusion Criteria:

* Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
* Patient required insulin within the prior 8 weeks
* Patient is on a weight loss program and is not in the maintenance phase
* Patient started on a weight loss medication (e.g., orlistat or sibutramine) within the prior 8 weeks
* Patient is on or likely to require treatment with treatment with immunosuppressive agents (e.g., cyclosporin, methotrexate)
* Patient has cirrhosis, active liver disease (other than fatty liver) or symptomatic gallbladder disease
* Patient has chronic myopathy, or a progressive neurological or neuromuscular disorder (e.g., multiple sclerosis or polymyositis)
* Patient has any of the following disorders within the past 6 months:

Acute coronary syndrome (e.g., MI or unstable angina), Coronary artery intervention, Stroke or transient ischemic neurological disorder.

* Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months
* Patient has severe peripheral vascular disease
* Patient has congestive heart failure
* Patient is HIV positive
* Patient has a clinically important hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
* Patient has a history of neoplastic disease
* Patient has a history of alcohol or drug abuse within the past 3 years
* Patient has viral hepatitis (hepatitis B or C)

Primary outcomes:
measure: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24
timeFrame: Baseline and week 24
Secondary outcomes:
measure: Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24
timeFrame: Baseline and week 24
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Rosenstock J, Brazg R, Andryuk PJ, Lu K, Stein P; Sitagliptin Study 019 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing pioglitazone therapy in patients with type 2 diabetes: a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2006 Oct;28(10):1556-68. doi: 10.1016/j.clinthera.2006.10.007.