A Phase III, Randomized, Double-Blind, Clinical Trial to Studythe Efficacy and Safety of MK-0431D (a fixed-dose combination[FDC] of sitagliptin and simvastatin) for the Treatment of PatientsWith Type 2 Diabetes Mellitus (T2DM) with Inadequate GlycemicControl on Metformin Monotherapy

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites750 target enrollmentOctober 18, 2012

ConditionsType 2 diabetes mellitus MedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

DrugsJANUVIA ZOCOR

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 2 diabetes mellitus
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Enrollment: 750
Status: Active, not recruiting
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 18, 2012

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Eligibility Criteria

Inclusion Criteria

•At Visit 1/Screening Visit
•1\. Patient has T2DM and must be \=18 and \=79 years of age on the day of signing informed consent.
•2\. Patient is a male, or a female who is highly unlikely to conceive as indicated by meeting at least one of the following criteria:
•a) Patient is not of reproductive potential. A female patient who is not of reproductive potential is defined as one who has either (1\) reached natural menopause (defined as \=12 months of spontaneous amenorrhea in women \>45 years of age, or \=6 months of spontaneous amenorrhea with serum FSH levels in the postmenopausal range as determined by the laboratory), or (2\) had bilateral oophorectomy and/or hysterectomy, or had bilateral tubal ligation at least 6 weeks prior to screening.
•b) Patient is of reproductive potential and agrees to remain abstinent or use (or have their partner use) two acceptable method of birth control within the projected duration of the study and for 14 days after the last dose of study medication.
•Acceptable methods of birth control are: hormonal contraception, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy.
•3\. Patient understands the study procedures, alternative treatments available and risks involved with the study, and voluntarily agrees to participate by giving informed
•written consent.
•4\. Provide written informed consent/assent for the trial. The subject may also provide consent/assent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
•Metabolic Entry Criteria

Exclusion Criteria

•At Visit 1/Screening Visit
•Glucose Metabolism and Therapy Criteria
•1\. Patient has a history of type 1 diabetes mellitus, or a history of ketoacidosis or patient is assessed by the investigator as possibly having type 1 diabetes confirmed with a C\-peptide \<0\.7 ng/mL (0\.23 nmol/L).
•Patients Requiring Specific Treatments
•2\. Patient has been on a thiazolidinedione (TZD) within the prior 16 weeks.
•3\. Patient has been treated with a statin or other lipid\-lowering agents, including over the counter (OTC) supplements of fish oils containing \>100 mg/day of EPA\+DHA, red yeast rice extract, Cholestin, fibrates, niacin (\>100 mg/day), or other lipidmodifying
•agents not listed above within 6 weeks prior to Visit 1/Screening Visit (see Appendix 6\.1 for the list of excluded medications).
•4\. Patient is currently participating in or has participated in another study in which the patient received an investigational compound or used an investigational device within the prior 12 weeks of signing the informed consent or is not willing to refrain from participating in any other study.
•5\. Patient is currently on or likely to require treatment with a prohibited medication (see Appendix 6\.1 for a list of excluded medications).
•6\. Patient intends to consume \>1\.2 liters of grapefruit juice per day during the course of the study.