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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01702298
First received: October 4, 2012
Last updated: November 7, 2014
Last verified: November 2014

October 4, 2012
November 7, 2014
December 2012
May 2013   (final data collection date for primary outcome measure)
  • Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Participants Who Experienced at Least One Adverse Event [ Time Frame: Up to 8 weeks (including 14 days after final dose of study drug) ] [ Designated as safety issue: Yes ]
    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.
  • Number of Participants Who Discontinued Study Drug Due to an Adverse Event [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: Yes ]
    Participants who were discontinued from study drug due to an adverse event during the 6 weeks of treatment.
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Number of participants who experienced at least one adverse event [ Time Frame: Up to 8 weeks (including 14 days after final dose of study drug) ] [ Designated as safety issue: Yes ]
  • Number of participants who discontinued study drug due to an adverse event [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01702298 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Change from baseline in LDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.
  • Change From Baseline in Total Cholesterol (TC) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Change from baseline in TC was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.
  • Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Change from baseline in non-HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.
  • Change From Baseline in Triglycerides (TG) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Change from baseline in TG was measured as a percent change from baseline at Week 6 (median and distribution free 95% confidence interval).
  • Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    Change from baseline in HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.
  • Change from baseline in low-density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Change from baseline in total cholesterol (TC) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Change from baseline in non-high density lipoprotein cholesterol (non-HDL-C) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Change from baseline in triglycerides (TG) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Change from baseline in high-density lipoprotein cholesterol (HDL-C) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)
An Open-label Study to Assess the Safety and Tolerability of MK-0431D for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Sitagliptin 100 mg/simvastatin 40 mg FDC
    Sitagliptin 100 mg/simvastatin 40 mg FDC tablet administered once daily in the evening for 6 weeks
    Other Name: MK-0431D
  • Drug: Metformin
    Participants will continue pre-study dose of metformin tablet(s) >=1000 per day
    Other Names:
    • Fortamet®
    • Glucophage®
    • Glucophage® XR
    • Glumetza®
    • Riomet®
    • Metgluco®
    • Glycoran®
Experimental: Sitagliptin 100 mg/simvastatin 40 mg FDC
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.
Interventions:
  • Drug: Sitagliptin 100 mg/simvastatin 40 mg FDC
  • Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
  • Currently being treated for hyperthyroidism or is on thyroid hormone replacement therapy and has not been on a stable dose for at least 6 weeks
  • History of malignancy <=5 years prior to study participation, except for basal cell or squamous cell skin cancer or in situ cervical cancer
  • Positive urine pregnancy test
  • Pregnant or breastfeeding, or is expecting to conceive or donate eggs during the study, including 14 days following the last dose of study drug
  • User of recreational or illicit drugs or has had a recent history of drug abuse
  • Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01702298
0431D-312
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP