Evaluation of Glucose Lowering Effect, Safety and Tolerability of CS-917 - Full Text View

Sponsored by:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00290940

Purpose

This study will compare glucose lowering with CS-917 compared to placebo after 3 months of treatment

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: CS-917 Drug: metformin hydrochloride Drug: pioglitazone	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Pioglitazone Pioglitazone hydrochloride Metformin Metformin hydrochloride Dextrose

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of CS-917 as Monotherapy for Type 2 Diabetes

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

Secondary Outcome Measures:

Onset of efficacy of CS-917
Safety and tolerability of CS-917
Changes in other relevant glycemic and metabolic measures
Proportion of subjects achieving therapeutic response
Proportion of subjects discontinuing or requiring rescue for continued or worsening hyperglycemia

Eligibility

Criteria

Inclusion Criteria:

Drug naive or newly diagnosed type 2 diabetic subjects:
Never received oral antihyperglycemic or insulin therapy or
No oral antihyperglycemic or insulin therapy for more than 6 months since original diagnosis and
No insulin therapy within one year of screening, with the exception of use during hospitalization or for use in gestational diabetes and
No antihyperglycemic therapy for more than three consecutive days, or a total of of seven non-consecutive days, during the 8 weeks prior to screening.
HbA1C>6.7% and < or = to 10% at screening

Exclusion Criteria:

Current insulin therapy
Symptoms of poorly controlled diabetes
History of diabetic ketoacidosis or hyperosmolar, nonketonic coma within one year of screening
Serum bicarbonate < or = to 19 meq/L
Serum creatinine (Scr) > 1.4 mg/dL (females) or 1.5 mg/dL (males)
Contraindication to metformin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290940

Sponsors and Collaborators

Daiichi Sankyo Inc.

More Information

Study ID Numbers:	CS0917-A-U205
Study First Received:	February 10, 2006
Last Updated:	September 10, 2007
ClinicalTrials.gov Identifier:	NCT00290940
Health Authority:	United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:

Diabetes mellitus, Type 2
High blood sugar
Hyperglycemia
Antihyperglycemic agents
CS-917

Study placed in the following topic categories:

Metabolic Diseases
Hyperglycemia
Pioglitazone
Metformin
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009