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A Study of the Efficacy and Safety of MK-0431D (a Fixed-dose Combination of Sitagliptin and Simvastatin) for the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-266)

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/Simvastatin FDC (Drug); Sitagliptin (Drug); Simvastatin (Drug); Placebo to sitagliptin (Drug); Placebo to simvastatin (Drug); Placebo to Sitagliptin/Simvastatin FDC (Drug); Metformin (Drug); Glimepiride (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

The purpose of this study is to assess the efficacy and safety of sitagliptin/simvastatin fixed-dose combination (FDC) in participants with T2DM who have inadequate glycemic control while on metformin monotherapy. The primary hypothesis of this study is that after 16 weeks of therapy, the mean change from baseline in hemoglobin A1C (A1C) in participants treated with sitagliptin/simvastatin FDC is non-inferior compared to sitagliptin alone.

Clinical Details

Official title: A Phase III, Randomized, Double-blind, Clinical Trial to Study the Efficacy and Safety of MK-0431D (a Fixed-dose Combination [FDC] of Sitagliptin and Simvastatin) for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy

Study design: Allocation: Randomized, Endpoint Classification: Safety/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 (Sitagliptin/Simvastatin FDC vs. Sitagliptin)

Number of Participants Who Experienced at Least One Adverse Event (AE)

Number of Participants Who Discontinued Study Drug Due to an Adverse Event

Secondary outcome:

Change From Baseline in A1C at Week 16 (Sitagliptin/Simvastatin FDC vs. Simvastatin)

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 16

Percent Change From Baseline in Total Cholesterol (TC) 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 (TG) at Week 16

Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 16

Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16

Percentage of Participants With A1C Level <7% at Week 16

Eligibility

Minimum age: 18 Years. Maximum age: 79 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- has T2DM

- (1) Male; (2) female not of reproductive potential; or (3) female of reproductive

potential who agrees to remain abstinent or use alone or in conjunction with their partner 2 methods of contraception to prevent pregnancy during the study and for 14 days after the last dose of study drug

- is currently on metformin monotherapy at a daily dose of at least 1500 mg for at

least 10 weeks

- is not on a lipid-lowering agent for at least 6 weeks prior to entering the study

Exclusion Criteria:

- has history of type 1 diabetes mellitus (T1DM), or a history of ketoacidosis or

possibly has T1DM

- has been on a thiazolidinedione (TZD) within the previous 16 weeks

- has been treated with a statin or other lipid-lowering agent (including

over-the-counter [OTC] supplements) within the previous 6 weeks

- currently participating in or has participated in another clinical study within the

past 12 weeks

- intends to consume >1. 2 liters of grapefruit juice daily during the study

- is on or likely to require treatment for at least 2 consecutive weeks or repeated

courses of corticosteroids (inhaled, nasal and topical corticosteroids are permitted)

- intolerance or hypersensitivity to sitagliptin, simvastatin, metformin or glimepiride

- is on a weight loss program and not in the maintenance phase or has started a weight

loss medication or has undergone bariatric surgery in the previous 12 months

- has undergone a surgical procedure in the past 4 weeks or planned major surgery

during the study

- has symptomatic hyperglycemia that requires immediate initiation, adjustment, or

addition of antihyperglycemic therapy

- has a history of myopathy or rhabdomyolysis with any statin

- has cardiovascular disease, a diagnosis of congestive heart failure, or uncontrolled

high blood pressure

- has a history of active liver disease

- has chronic progressive neuromuscular disorder, human immunodeficiency virus (HIV),

hematological disorder, or uncontrolled endocrine or metabolic disease

- is currently being treated for hyperthyroidism or is on thyroid hormone therapy and

has not been on a stable dose for at least 6 weeks

- has a history of malignancy in the previous 5 years (excluding adequately treated

basal cell or squamous cell skin cancer or in situ cervical cancer)

- is pregnant or breast feeding, or is expecting to conceive or donate eggs during the

course of the study, including 14 days after the last dose of study drug

- is a user of recreational or illicit drugs or has had a recent history of drug abuse

- consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in

binge drinking

Locations and Contacts

Additional Information

Starting date: October 2012
Last updated: October 16, 2014

Page last updated: August 23, 2015

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