Canagliflozin Vs Placebo in Older Subjects with T2DM

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Compared With Placebo in the Treatment of Older Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Glucose Lowering Therapy

• IRAS ID

  53054

• Contact name

  John Robinson

• Sponsor organisation

  Quintiles Ltd

• Eudract number

  2010-018411-15

• Research summary

  Over the past decades, the incidence of type 2 diabetes mellitus (T2DM) has been rapidly rising worldwide, primarily due to an increase in the incidence of obesity and sedentary lifestyles. T2DM is an age-related disease and thus assessing the effectiveness of new diabetes medications in older individuals is of particular importance. Despite the availability of a range of treatment options, many patients with T2DM can't achieve or maintain normal blood sugar levels. Canagliflozin is an experimental drug that is being tested to see if it may be useful in treating T2DM. Previous studies with canagliflozin have been completed in a total of approximately 1200 people. Results from these studies indicate that canagliflozin is effective in controlling blood sugar levels and is associated with a reduction in body weight as well as an effect on bone. The current study will evaluate how effective and safe canagliflozin is in the treatment of older people (=55 to =80 years of age) with T2DM who are inadequately treated on their current diabetes medication or are currently not taking treatment for their diabetes. In addition, the effects of canagliflozin on bone density and on body composition will be examined. Approximately 720 participants will be randomly assigned to either canaglifozin 100mg, canagliflozin 300mg or matching placebo (a pill that looks like canagliflozin but has no real medicine or active ingredients). This once daily capsule will be taken in addition to the participant's ongoing diabetes treatment, which must remain the same (type of treatment and dose) throughout the study. The total duration of the study will be approximately 108 weeks for each subject, including a 104-week treatment period and 30-day follow-up period.

• REC name

  Scotland A REC

• REC reference

  10/MRE00/60

• Date of REC Opinion

  29 Sep 2010

• REC opinion

  Further Information Favourable Opinion