Clinical trial NCT00902161: A Single-Dose Crossover Study of MK0893 in Patients With Type 2 Diabetes (0893-019 AM4)(COMPLETED)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-05-15
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will assess the effect of combined treatment with MK0893 plus propranolol versus placebo plus propranolol on hypoglycemia.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Recovery Time (Rt[65] From Insulin-induced Hypoglycemia
timeFrame: From the time of hypoglycemic clamp (t=0 minutes) through 270 minutes
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax) and Concentration Average Over 8-12 Hours (C[Ave] 8-12 hr) Post Single Dose MK0893
timeFrame: From time of MK0893 administration through 24 hours post-dose
measure: Plasma Concentration at 32 Hours (C[32hr]) Post Single Dose MK0893
timeFrame: From time of MK0893 administration through estimated 32 hours post-dose
measure: Number of Participants With An Adverse Event (AE)
timeFrame: From time of administration of study treatment through end of Post-Study (up to 21 days after administration of last dose of study treatment).
measure: Number of Participants Who Discontinued Study Treatment Due To AEs
timeFrame: From time of first administration of study treatment to time of last administration of study treatment (up to Day 21)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: