Study of the Safety and Efficacy of MK-8521 Compared to Placebo and a Diabetes Drug in Participants With Type 2 Diabetes Mellitus (MK-8521-003)

• Status: Completed
• Trial end date: 2014-10-03
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, efficacy, and pharmacokinetics of MK-8521 given once daily compared to placebo and another diabetes drug in participants with Type 2 diabetes mellitus (T2DM).

This study was modified by a protocol amendment to a 2-part trial to further test the safety and tolerability of MK-8521 at higher doses and to compare MK-8521 pharmacokinetics between participants with T2DM and healthy participants. An additional cohort of T2DM participants and a cohort of non-diabetic obese participants have been added.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Liraglutide

Criteria

Inclusion Criteria:

• Male, or female of non-childbearing potential with Type 2 diabetes mellitus (Parts I and II) or non-diabetic (Part II)

• Body mass index (BMI) between: 27 >= and <= 40 kg/m^2

• A1C (average blood sugar for the past 2 to 3 months) value >= 7.0 and <= 11.0 % (Part I) or >= 6.5 and <= 11.0 % (Part II) at the time of screening (T2DM participants)

• A1C value < 5.7 at the time of screening (non-diabetic subjects in Part II only)

• On a stable dose of metformin (>=1000 mg total daily dose) for at least 12 weeks at the time of screening (T2DM participants)

Exclusion Criteria:

• Mentally or legally incapacitated

• History of clinically significant psychiatric disorder of the last 5 years. Participants with situational depression may be enrolled in the trial at the discretion of the Investigator

• History of Type 1 diabetes mellitus or a history of ketoacidosis

• History of clinically significant gastrointestinal, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological abnormalities or diseases

• History of cardiovascular disease or cardiac conduction disorder

• History of cancer (malignancy). Exceptions may include adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies which have been successfully treated >=10 years prior to the pre-screening visit

• History of proliferative diabetic retinopathy or maculopathy

• Clinically significant diabetic autonomic neuropathy

• QTc interval >= 470 msec (for males) or >= 480 msec (for females)

• Clinical significant electrocardiogram (ECG) abnormality

• Positive for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus (HIV)

• On a weight loss program and is not weight-stable (weight stable is defined history of <5% change in body weight in the last 3 months

• On a weight loss medication or has undergone bariatric surgery

• Major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pretrial (screening) visit

• Participated in another investigational trial within 4 weeks prior to the pretrial (screening) visit

• History of acute or chronic pancreatitis of any etiology

• Mean value for triplicate semi-recumbent systolic blood pressure >160 mm Hg and/or diastolic blood pressure >90 mm Hg (after at least a 10-minute seated rest) and blood pressure is considered unlikely to be below these limits by Day-1 (Randomization) with initiation or adjustment of antihypertensive medication

• Event of severe hypoglycemia with seizure or loss of consciousness in the past 12 months

• Treated with anti-hyperglycemic agents other than metformin within the last 12 weeks

• Previous exposure to any glucagon-like peptide-1 (GLP-1) receptor agonist (e.g. Byetta™, Victoza™ or investigational agents)