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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 16

Percent 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 16

Percent 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

Page last updated: August 23, 2015

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