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Completed

NCT Number: NCT00290940

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

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CS-917

Drug

Metformin Hydrochloride

Drug

pioglitazone

Drug

Primary outcomes

  1. Mean change from baseline in HbA1C after 12 weeks compared to placebo

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Feb 13, 2006
Registry last updated
Sep 11, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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