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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014