Bioequivalence Study of Dapagliflozin/Metformin tab v individual tabs

• Research type

  Research Study

• Full title

  A Bioequivalence Study of the Fixed-dose Combination Dapagliflozin/Metformin Tablet (5 mg/850 mg) Relative to a 5-mg Dapagliflozin Tablet and an 850-mg Metformin (Glucophage® Marketed in Canada by Sanofi-Aventis) Tablet Coadministered to Healthy Volunteers in the Fasted and Fed States

• IRAS ID

  124401

• Contact name

  Saeed Khan

• Sponsor organisation

  AstraZeneca R&D Mölndal

• Eudract number

  2013-000169-36

• Research summary

  This study involves the administration of two different drugs for Type 2 Diabetes Mellitus (T2DM); Dapagliflozin and Metformin which will be given by mouth either as a combination tablet or separately.Dapagliflozin is a new drug for the treatment of T2DM. It has been approved for the treatment of type 2 diabetes in the European Union (EU) and Australia. Metformin is a licensed medication prescribed worldwide for T2DM. Dapagliflozin is being developed by AstraZeneca and Bristol-Myers Squibb (pharmaceutical companies) and this study is being carried out on behalf of AstraZeneca by Quintiles Drug Research Unit at Guy’s Hospital (referred as Quintiles in the remainder of the document).So far Dapagliflozin has been given, either alone or in combination with Metformin, to more than 5000 people (including healthy volunteers and patients with T2DM) in clinical trials worldwide.When blood flows to the kidney, the glucose in the blood gets filtered into the urine in the first part of the kidney and then gets reabsorbed later in kidney. Sodium glucose co-transporter (SGLT2) is a protein in the kidneys and is responsible for most of the glucose reabsorption in people. This contributes to the high blood glucose levels found in the T2DM. Dapagliflozin inhibits the activity of SGLT2 which results in decrease reabsorption of glucose. The excess glucose is excreted in the urine thereby reducing the risk of blood sugar rising too high.In this study we are investigating whether the combination of Dapagliflozin/Metformin (in a single tablet) is equivalent to Dapagliflozin and Metformin when given separately at the same time by mouth on full stomach (fed state) and on empty stomach (fasting state).At least 36 healthy male and female volunteers aged 18-55 years will be enrolled in the study to ensure that 32 subjects complete the study.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  13/LO/0349

• Date of REC Opinion

  3 Apr 2013

• REC opinion

  Favourable Opinion