A Study to Assess the Safety and Tolerability of Sitagliptin/Simvastatin Fixed-dose Combination (FDC) in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-312)

NCT01702298 | Completed Phase 3 Results

• 1 other identifier: 0431D-312
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to examine the safety and tolerability of sitagliptin 100 mg/simvastatin 40 mg FDC (MK-0431D) in Vietnamese participants with type 2 diabetes mellitus with inadequate glycemic control on metformin.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Fasting Plasma Glucose (FPG)

  Change from baseline in FPG at Week 6 based on longitudinal data analysis (LDA) model including both baseline and post-baseline measurements as response variable and term time.

  Baseline and Week 6

• Percentage of Participants Who Experienced at Least One Adverse Event

  An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.

  Up to 8 weeks (including 14 days after final dose of study drug)

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

  Participants who were discontinued from study drug due to an adverse event during the 6 weeks of treatment.

  Up to 6 weeks

Secondary Outcomes (5)

• Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)

  Baseline and Week 6

• Change From Baseline in Total Cholesterol (TC)

  Baseline and Week 6

• Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C)

  Baseline and Week 6

• Change From Baseline in Triglycerides (TG)

  Baseline and Week 6

• Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)

  Baseline and Week 6

Study Arms (1)

Sitagliptin 100 mg/simvastatin 40 mg FDC

EXPERIMENTAL

Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants will continue pre-study dose of metformin \>=1000 mg per day.

Drug: Sitagliptin 100 mg/simvastatin 40 mg FDC; Drug: Metformin

Interventions

Sitagliptin 100 mg/simvastatin 40 mg FDC DRUG

Sitagliptin 100 mg/simvastatin 40 mg FDC tablet administered once daily in the evening for 6 weeks

Also known as: MK-0431D

Sitagliptin 100 mg/simvastatin 40 mg FDC

Metformin DRUG

Participants will continue pre-study dose of metformin tablet(s) \>=1000 per day

Also known as: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®

Sitagliptin 100 mg/simvastatin 40 mg FDC

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has type 2 diabetes mellitus
• Male, or female who is not of reproductive potential or if of reproductive potential agrees to abstain or use (or have their partner use) two acceptable methods of birth control during the study and for 14 days after the last dose of study drug
• Currently on metformin monotherapy (\>=1000 mg per day) for at least 4 weeks prior to study participation
• Not on statin therapy or other lipid-lowering agent for at least 6 weeks prior to study participation

You may not qualify if:

• History of type 1 diabetes mellitus or a history of ketoacidosis
• History of 2 or more episodes of hypoglycemia resulting in seizure, coma or loss of consciousness over the past 3 months
• On a thiazolidinedione (TZD) within the past 12 weeks
• Has been treated with a statin or other lipid-lowering agent within 6 weeks prior to study participation
• Is on or likely to require treatment with a prohibited medication (itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, gemfibrozil, cyclosporine, danazol, amiodarone, verapamil, diltiazem, amlodipine, ranolazine, niacin)
• Intends to consume \>1.2 liters of grapefruit juice per day during the study
• Is on or likely to require treatment for \>=2 consecutive weeks or repeated courses of corticosteroids (inhaled, nasal and topical corticosteroids are permitted)
• Is on a weight loss program and not in the maintenance phase or has started a weight loss medication or has undergone bariatric surgery within 12 months prior to study participation
• Has undergone a surgical procedure within 4 weeks of study participation or has planned major surgery during the study
• History of myopathy or rhabdomyolysis with any statin
• History of myocardial infarction, unstable or stable angina, angioplasty, bypass surgery, myocardial ischemia, peripheral artery disease, abdominal aortic aneurysm, transient ischemic attacks, stroke of carotid origin or \>50% obstruction of a carotid artery
• Diagnosis of congestive heart failure with New York Heart Association (NYHA) Class III or IV cardiac status
• History of active liver disease (other than non-alcoholic steatosis) including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
• Chronic progressive neuromuscular disorder
• Human immunodeficiency virus (HIV)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; Simvastatin; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Biguanides; Guanidines; Amidines

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2012
• First Posted: October 8, 2012
• Study Start: December 7, 2012
• Primary Completion: May 29, 2013
• Study Completion: May 29, 2013
• Last Updated: August 24, 2018
• Results First Posted: May 30, 2014

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share