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

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00290940
First received: February 10, 2006
Last updated: September 10, 2007
Last verified: September 2007
History of Changes
  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 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Mean change from baseline in HbA1C after 12 weeks compared to placebo

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

Estimated Enrollment: 400
Study Start Date: January 2006
Study Completion Date: April 2007
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Show 66 Study Locations
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00290940     History of Changes
Other Study ID Numbers: CS0917-A-U205
Study First Received: February 10, 2006
Last Updated: September 10, 2007
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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Pioglitazone
Hypoglycemic Agents
Metformin
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013