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

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites825 target enrollmentJune 21, 2012

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

DrugsJANUVIA LIPITOR Glimepiride

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Type 2 diabetes mellitus
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Enrollment: 825
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 21, 2012

End Date

December 4, 2012

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

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 is \=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 at least one yes” answer to the following questions:
•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 \=6 months of spontaneous amenorrhea with serum FSH levels in the postmenopausal range as determined by the laboratory, or \=12 months of spontaneous amenorrhea in women \>45 years of age), (2\) undergone a bilateral oophorectomy and/or hysterectomy, or bilateral tubal ligation.
•b) Patient is of reproductive potential and agrees to remain abstinent or use (or have their partner use) two acceptable methods 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 contraceptives, 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.
•Metabolic Entry Criteria
•4\. Patient is currently on monotherapy with metformin at a dose of \=1500 mg/day for at least 8 weeks and has a Visit 1/Screening Visit A1C \=7% and \=10%.
•5\. Patient is not on statin therapy or other lipid\-lowering agents for at least 6 weeks and has a Visit 1/Screening Visit LDL\-C \=70 mg/dL (1\.81 mmol/L) and \=130 mg/dL (3\.37 mmol/L).
•At Visit 3/Day 1/Randomization

Exclusion Criteria

•1\.Patient has a history of type 1 diabetes mellitus, 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).
•2\.Patient has ever taken a DPP\-4 inhibitor (such as sitagliptin, vildagliptin, alogliptin, or saxagliptin) or a GLP\-1 mimetic (such as exenatide or liraglutide), or the patient has required insulin therapy within 12 weeks prior to signing informed consent.
•3\.Patient has been on a PPAR? agonist (TZD) within the prior 12 weeks.
•4\.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, bile\-acid sequestrants, fibrates, niacin (\>100 mg/day), or other lipid\-modifying agents not listed above within 6 weeks prior to Visit 1/Screening Visit.
•5\.Patient is currently participating in or has participated in another study with an investigational compound or device within the prior 12 weeks of signing the informed consent and does not agree to refrain from participating in any other study while participating in this study.
•6\.Patient is currently taking, or intends to take during the course of the study, any excluded medications as listed in Appendix 6\.1\. This includes, but is not limited to any potent inhibitor of CYP3A4 (e.g., itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, protease inhibitors, or nefazodone), or medications that could increase the risk of myopathy (e.g., cyclosporine).
•7\.Patient intends to consume \>1\.2 liters of grapefruit juice per day during the course of the study.
•8\.Patient is on or is likely to require treatment with \=14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.
•9\.Patient has a history of hypersensitivity or any contraindication to sitagliptin, atorvastatin, metformin or glimepiride based upon the labels of the country of the investigational site.
•10\.Patient 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.