Efficacy,Safety&Tolerability of ASP1941 in Combination with Metformin

• Research type

  Research Study

• Full title

  Phase IIb, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12-Week Treatment with ASP1941 in Combination with Metformin in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone

• IRAS ID

  40433

• Contact name

  John Robinson

• Sponsor organisation

  Astellas Pharma Europe B.V.

• Eudract number

  2009-013881-25

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Diabetes mellitus is defined as a metabolic disorder in which elevated blood glucose levels (Hyperglycemia) occur. Hyperglycemia is caused by deficient insulin action determined by both the capacity to secrete insulin from THE pancreas and insulin action in tissues such as the muscle, the fat and the liver. Diabetes mellitus is classified into two basic categories: type 1 and type 2. Impaired insulin secretion is the major cause of type 1 diabetes mellitus, while both impaired insulin secretion and insulin resistance play important roles in Type 2 Diabetes Mellitus (T2DM). This study will assess the efficacy, safety and tolerability of a 12 week treatment with Asp1941 in combination with Metformin in patients with T2DM who have inadequate glycemic control on Metformin alone. To be eligible to take part in this trial amongst other factors patients must be 18 years of age or over. It is estimated that 315 patients will be enrolled in the study. Patient??s participation is expected to last for approximately 18 weeks (4.5 months). Patients who meet the inclusion criteria and none of the exclusion criteria will be randomised to one of the following treatment groups: Group 1: ASP1941 12.5 mg once daily Group 2: ASP1941 50 mg once daily Group 3: ASP1941 150 mg once daily Group 4: ASP1941 300 mg once daily Group 5: Placebo matching ASP1941 once daily The study will comprise a single-blind, 2-week placebo run-in period followed by a randomised, double-blind, placebo-controlled, 12-week treatment period. Patients will visit the clinic at screening (Visit 1), at the end of the placebo run-in period (Visit 2), after 1, 2, 4, 8 and 12 weeks of double-blind treatment (Visits 3, 4, 5, 6 and 7) and at follow-up 1 and 4 weeks after the 12-week double-blind treatment period (Visits 8 and 9, respectively). At the end of the study, the study doctor will discuss alternative treatment for the patient.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  10/H0206/3

• Date of REC Opinion

  26 Feb 2010

• REC opinion

  Further Information Favourable Opinion