A Single-Dose Crossover Study of MK0893 in Patients With Type 2 Diabetes - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00902161

Purpose

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

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: MK0893 Drug: Comparator: placebo Drug: Comparator: propranolol	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Hypoglycemia

Drug Information available for: Propranolol hydrochloride Propranolol Dexpropranolol

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Time required to recover from insulin-induced hypoglycemia [ Time Frame: 12 hours post dose of study drug ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety and tolerability of combined treatment with MK0893 and propranolol based on assessment of clinical and laboratory adverse experiences [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	18
Study Start Date:	April 2009
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 MK0893	Drug: MK0893 Single dose of MK0893 1000 mg (ten 100 mg tablets) Drug: Comparator: propranolol Propranolol tablets titrated up to 80 mg three times daily over a four week period. Total treatment will be approximately 7 weeks.
Placebo Comparator: 2 Placebo	Drug: Comparator: placebo Single dose of placebo to MK0893 Drug: Comparator: propranolol Propranolol tablets titrated up to 80 mg three times daily over a four week period. Total treatment will be approximately 7 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient has Type 2 Diabetes (T2DM)
Patient is either: Not on an oral antihyperglycemic medication for at least 6 weeks; on a single oral antihyperglycemic medication that is not a PPARg agonist (e.g. Avandia); OR on a combination of no more than two antihyperglycemic medications that are not PPARg agonists
Patients have not received insulin for at least 6 months
Patient has not been treated with a PPARg agonist for at least 12 weeks
Patient has been a nonsmoker for at least 6 months

Exclusion Criteria:

Patient has a history of stroke, seizures, or neurological disorders
Patient cannot tolerate insulin or propranolol
Patient has a history of asthma, emphysema or chronic bronchitis
Patient 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
Patient is on or may require treatment with drugs that affect the immune system or with corticosteroids
Patient has a history of heart failure or coronary artery disease
Patient has a history of uncontrolled high blood pressure
Patient is HIV, hepatitis B or hepatitis C positive
Patient has a history of Type 1 diabetes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902161

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00902161 History of Changes
Other Study ID Numbers:	2009_592, MK0893-019
Study First Received:	May 13, 2009
Last Updated:	November 30, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Propranolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

Pharmacologic Actions
Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents

ClinicalTrials.gov processed this record on February 09, 2012