A Single-Dose Crossover Study of MK0893 in Patients With Type 2 Diabetes (0893-019 AM4)(COMPLETED)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: MK0893 (Drug); MK0893-matched Placebo (Drug); Propranolol Hydrochloride (HCL) (Drug)
Phase: Phase 1
Sponsored by: Merck Sharp & Dohme Corp.
Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
This study will assess the effect of combined treatment with MK0893 plus propranolol versus
placebo plus propranolol on hypoglycemia.
Official title: A Double-Blind, Randomized, Placebo-Controlled, Single-Dose Crossover Study to Assess the Safety and Tolerability of MK0893 Coadministered With Propranolol Hydrochloride in Patients With Type 2 Diabetes
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Recovery Time (Rt From Insulin-induced Hypoglycemia
Maximum Plasma Concentration (Cmax) and Concentration Average Over 8-12 Hours (C[Ave] 8-12 hr) Post Single Dose MK0893
Plasma Concentration at 32 Hours (C[32hr]) Post Single Dose MK0893
Number of Participants With An Adverse Event (AE)
Number of Participants Who Discontinued Study Treatment Due To AEs
Minimum age: 18 Years.
Maximum age: 60 Years.
- Participant has Type 2 Diabetes (T2DM)
- Participant is either: Not on an oral antihyperglycemic medication for at least 6
weeks; on a single oral antihyperglycemic medication that is not a peroxisome
proliferator-activated gamma (PPAR-gamma) agonist (e. g. Avandia); OR on a combination
of no more than two antihyperglycemic medications that are not PPAR-gamma) agonists
- Participant has not received insulin for at least 6 months
- Participant has not been treated with a PPAR-gamma agonist for at least 12 weeks
- Participant has been a nonsmoker for at least 6 months
- Female participants who are non-pregnant and highly unlikely to conceive due to
surgical sterilization, post-menopausal status, not heterosexually active, or willing
to use 2 birth control methods
- Participant has a history of stroke, seizures, or neurological disorders
- Participant cannot tolerate insulin or propranolol
- Participant has a history of asthma, emphysema or chronic bronchitis
- Participant is on a weight loss program that is not in the maintenance phase or has
been treated with a weight loss medication within 8 weeks of screening
- Participant is on or may require treatment with drugs that affect the immune system
or with corticosteroids
- Participant has a history of heart failure or coronary artery disease
- Participant has a history of uncontrolled high blood pressure
- Participant is Human Immunodeficiency (HIV), hepatitis B or hepatitis C positive
- Participant has a history of Type 1 diabetes
- Participant has a history of hypoglycemia unawareness documented by a blood glucose
concentration < 55 mg/dL (3. 1 mol/L) without symptoms of hypoglycemia.
Locations and Contacts
Starting date: May 2009
Last updated: June 8, 2015