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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of CS-917 as Monotherapy for Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00290940
• Other study ID #: CS0917-A-U205
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2006
• Last updated: September 10, 2007
• Start date: January 2006
• Est. completion date: April 2007

Study information

• Verified date: September 2007
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• CS-917

• metformin hydrochloride

• pioglitazone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in HbA1C after 12 weeks compared to placebo
Secondary	Onset of efficacy of CS-917
Secondary	Safety and tolerability of CS-917
Secondary	Changes in other relevant glycemic and metabolic measures
Secondary	Proportion of subjects achieving therapeutic response
Secondary	Proportion of subjects discontinuing or requiring rescue for continued or worsening hyperglycemia