A Study of the Co-administration of Sitagliptin and Atorvastatin in Inadequately Controlled Type 2 Diabetes Mellitus (MK-0431E-211)
Type 2 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- has type 2 diabetes mellitus
- is a male, or a female who is highly unlikely to conceive
- is currently on monotherapy with metformin (at least 1500 mg/day) for at least 8 weeks
- is not on statin therapy or other lipid-lowering agents for at least 6 weeks
Exclusion Criteria:
- has a history of type 1 diabetes mellitus, ketoacidosis or possibly has type 1 diabetes
- has ever taken a dipeptidyl peptidase IV inhibitor (such as sitagliptin, vildagliptin, alogliptin, or saxagliptin) or a glucagon-like peptide-1 mimetic (such as exenatide or liraglutide), or has required insulin therapy within 12 weeks prior to signing informed consent
- has been on a peroxisome proliferator-activated receptor gamma agonist within the prior 12 weeks
- has been treated with a statin or other lipid-lowering agents, including over the counter supplements of fish oils within 6 weeks
- intends to consume at least 1.2 liters of grapefruit juice per day during the course of the study
- is on or is likely to require treatment with 14 consecutive days or more, or repeated courses of corticosteroids
- is on a weight loss program and not in the maintenance phase or has started a weight loss medication (such as orlistat or sibutramine) within the prior 8 weeks
- has undergone a surgical procedure within the prior 4 weeks
- has a history of myopathy or rhabdomyolysis with any statin.
- has cardiovascular disease
- has New York Heart Association (NYHA) Class III or IV congestive heart failure, inadequately controlled hypertension, a medical history of active liver disease, chronic progressive neuromuscular disorder, is human immunodeficiency virus (HIV) positive, has a clinically significant hematological disorder, uncontrolled endocrine or metabolic disease known to influence glycemic control or serum lipids/lipoproteins, untreated hyperthyroidism or is currently under treatment for hyperthyroidism
- has a history of malignancy within 5 years, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- is pregnant or breastfeeding, or is intending to become pregnant or donate eggs within the projected duration of the study and post-study follow-up period
- uses recreational or illicit drugs or has had a recent history (within the last year) of drug abuse or increased alcohol consumption
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Experimental
Sitagliptin/Sitagliptin + Atorvastatin
Atorvastatin/Atorvastatin + Glimepiride
Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin
In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.