A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess Cardiovascular Outcomes Following Treatment with MK-3102 in Subjects with Type 2 Diabetes Mellitus

Phase 1

Active, not recruiting

• Conditions: Type 2 Diabetes Mellitus; MedDRA version: 14.1Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-002414-39-IT
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-19
• Study Completion: 2017-03-22
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 4202

Inclusion Criteria

1. Having T2DM and is =40 years of age. 2. Receiving one of the following diabetes treatment regimens and has A1C of =7.0% and =10.0%: (a) treated by diet and exercise alone (not on AHA for =12 weeks) (b) on metformin, a sulfonylurea, a meglitinide, pioglitazone, or an alpha-glucosidase inhibitor as mono- or dual combination therapy continuously for at least 12 weeks (except for pioglitazone for at least 16 weeks) without dose alterations. (c) on a stable insulin regimen with one of the following insulins, alone or in combination with metformin: intermediate-acting insulin (e.g., NPH); pre-mixed insulin (e.g., Novolog 70/30, Novolin 70/30, Humalog 75/25, or Humulin 70/30); or long-acting insulin (e.g., glargine, detemir, degludec) 3. Having following preexisting vascular disease: (a) History of a major clinical manifestation of coronary artery disease (i.e., myocardial infarction, surgical or percutaneous [balloon and/or stent] coronary revascularization procedure, or coronary angiography showing at least one stenosis =50% in a major epicardial artery or branch vessel); (b)Ischemic cerebrovascular disease, including: - History of ischemic stroke - History of carotid arterial disease as documented by =50% stenosis documented by carotid ultrasound, magnetic resonance imaging (MRI), or angiography, with or without symptoms of neurologic deficit. (c) Atherosclerotic peripheral arterial disease, as documented by objective - amputation due to vascular disease, current symptoms of intermittent claudication confirmed by an ankle-brachial pressure index or toe brachial pressure index less than 0.9 or history of surgical or percutaneous revascularization procedure. 4. (a) Subject is a female not of reproductive potential defined as one who has either reached natural menopause or had bilateral oophorectomy and/or hysterectomy, or had bilateral tubal ligation at least 6 weeks prior to screening. (b) Subject is a female of reproductive potential, agrees to remain abstinent from heterosexual activity, or use (or have their partner use) 2 adequate barrier methods of contraception to prevent pregnancy within the projected duration of the trial and for 21 days after the last dose of study medication. 5. Understanding the trial procedures, alternative treatments available, providing the providing written informed consent, consent for Future Biomedical Research can be provided (not obligatory).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

1. History of type 1 diabetes mellitus or a history of ketoacidosis or possibly having type 1 diabetes 2. Beeing treated with rosiglitazone, a DPP-4 inhibitor or a GLP-1 receptor agonist within the prior 12 weeks of Visit 1/Screening. 3. Having a history of hypersensitivity to a DPP-4 inhibitor 4. Participation in trial with investigational compound prior 12 weeks of signing the informed consent or is not willing to refrain from participating in another trial. 5. Beeing in weight loss program, not in the maintenance phase or has started a weight loss medication or has undergone bariatric surgery within 12 months prior to signing the informed consent. 6. Surgical procedure within 4 weeks prior to signing informed consent or has planned major surgery during the trial. 7. Treatment for =14 consecutive days or repeated courses of pharmacologic doses of corticosteroids 8. Treatement for hyperthyroidism or thyroid replacement therapy and has not been on a stable dose for at least 6 weeks. 9. Medical history of active liver disease 10. Human immunodeficiency virus (HIV) as assessed by medical history. 11. Worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months. 12. Poorly-controlled hypertension 13. History of malignancy =5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer. 14. Clinically important hematological disorder 15. Exclusionary laboratory values 16. Positive urine pregnancy test. 17. Pregnancy or breast-feeding 18. At the time of signing informed consent using recreational or illicit drugs or has had a recent history of drug abuse. 19. Subject routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking. 20. History or current evidence of condition, therapy, lab abnormality or other circumstance that makes participation not in the subject's best interest. 21. Donating blood products or has had phlebotomy of >300 mL within 8 weeks of signing informed consent, or intending to donate blood products within the projected duration of the trial OR receiving blood products within 12 weeks of signing informed consent or within the projected duration of the trial. 22. Subject is unlikely to adhere to the trial procedures, keep appointments.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified