A Study of the Co-administration of Sitagliptin and Atorvastatin in Inadequately Controlled Type 2 Diabetes Mellitus (MK-0431E-211)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: Sitagliptin (Drug); Atorvastatin (Drug); Placebo to sitagliptin (Other); Placebo to atorvastatin (Other); Metformin (Drug); Glimepiride (Drug); Placebo to glimepiride (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Merck Sharp & Dohme Corp.
Summary
This 2 phase study will examine if 16 weeks of treatment with sitagliptin in combination
with atorvastatin reduces hemoglobin A1C (A1C) and low density lipoprotein cholesterol
(LDL-C) from baseline more than atorvastatin alone and sitagliptin alone, respectively.
Following a single-blind placebo run-in period, participants were randomized to one of three
treatment arms (sitagliptin monotherapy with placebo to atorvastatin, atorvastatin
monotherapy with placebo to sitagliptin, or sitagliptin plus atorvastatin) for 16 weeks
(Phase A). During Phase B of the study (Weeks 16 through 54), participants received either
sitagliptin plus atorvastatin with placebo to glimepiride or glimepiride plus atorvastatin
with placebo to sitagliptin.
Clinical Details
Official title: A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Co-administration of Sitagliptin and Atorvastatin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change from baseline in hemoglobin A1C (A1C) at Week 16Percent change from baseline in low density lipoprotein cholesterol (LDL-C) at Week 16
Secondary outcome: Change from baseline in fasting plasma glucose (FPG) at Week 16Percent change from baseline in total cholesterol at Week 16 Percent change from baseline in apolipoprotein B (Apo B) at Week 16 Percent change from baseline in non-high density lipoprotein cholesterol (non-HDL-C) at Week 16 Percent change from baseline in triglycerides at Week 16 Percent change from baseline in very low-density lipoprotein cholesterol (VLDL-C) at Week 16 Percent change from baseline in high density lipoprotein cholesterol (HDL-C) at Week 16
Eligibility
Minimum age: 18 Years.
Maximum age: 79 Years.
Gender(s): Both.
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 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
Locations and Contacts
Additional Information
Starting date: October 2011
Last updated: November 7, 2014
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