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:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety Study
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:

MedlinePlus related topics: Diabetes 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
1: Experimental 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.
2: Placebo Comparator 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:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2009_592, MK0893-019
Study First Received:	May 13, 2009
Last Updated:	November 30, 2009
ClinicalTrials.gov Identifier:	NCT00902161 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents

Antihypertensive Agents
Pharmacologic Actions
Propranolol
Therapeutic Uses
Diabetes Mellitus, Type 2
Adrenergic beta-Antagonists
Adrenergic Antagonists
Anti-Arrhythmia Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010