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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00290940
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : September 11, 2007
Information provided by:
Daiichi Sankyo, Inc.

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: CS-917 Drug: metformin hydrochloride Drug: pioglitazone Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2006
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. Onset of efficacy of CS-917
  2. Safety and tolerability of CS-917
  3. Changes in other relevant glycemic and metabolic measures
  4. Proportion of subjects achieving therapeutic response
  5. Proportion of subjects discontinuing or requiring rescue for continued or worsening hyperglycemia

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00290940

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Sponsors and Collaborators
Daiichi Sankyo, Inc. Identifier: NCT00290940     History of Changes
Other Study ID Numbers: CS0917-A-U205
First Posted: February 13, 2006    Key Record Dates
Last Update Posted: September 11, 2007
Last Verified: September 2007

Keywords provided by Daiichi Sankyo, Inc.:
Diabetes mellitus, Type 2
High blood sugar
Antihyperglycemic agents

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