Vildagliptin+metformin vs gliclazide+metformin in Type 2 Diabetes, V1

• Research type

  Research Study

• Full title

  A double blind, double dummy, randomised, multi-centre study to assess the tolerability and efficacy profile of vildagliptin compared to gliclazide as dual therapy with metformin in Muslim patients with type 2 diabetes fasting during Ramadan

• IRAS ID

  114631

• Contact name

  Fosca De Iorio

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2011-005499-41

• Research summary

  The is a 2-arm standard study design comparing the vildagliptin + metformin arm to gliclazide + metformin arm in approx. 552 Muslim patients with type 2 diabetes mellitus who are fasting during Ramadan. Overall duration of the study can vary from 12 to 30 weeks, depending on when the patient enters the study. The study population consists of male and female patients aged 18 years or older who are treated with metformin plus a sulfonylurea/SU (a medication that lowers the level of blood sugar) and glycosylated haemoglobin/HbA1c (a lab test showing the amount of sugar in the blood and how well the diabetes is controlled) equal to/less than 8.5%. The risk of hypoglycaemia (low blood sugar levels) can be increased during the Ramadan fasting period and controlling blood sugar levels in type 2 diabetic patients who fast during this period is harder to achieve. The purpose of this study is to assess whether: - there are fewer hypoglycaemic events experienced in type 2 diabetic, Muslim patients who are fasting during Ramadan in the vildagliptin+metformin group versus the gliclazide+metformin group - the HbA1c reduction with vildagliptin+metformin treatment is not inferior to that of gliclazide+metformin treatment Patients will attend 4 study related visits, the first of which is visit 1/Screening to assess the patients’ suitability for the study, which lasts approximately 4 weeks following written informed consent. During visit 2, patients will undergo the necessary assessments and be randomly assigned to receive either vildagliptin+metformin treatment or gliclazide+metformin and will receive their first dose. Visit 3 will occur within 4 weeks to 1 day before Ramadan. The final visit 4 will occur within 4 weeks of the end of the Ramadan fasting period. The research site staff will contact the patient weekly by phone starting 1 week before the start of Ramadan until the end of Ramadan.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  12/SW/0318

• Date of REC Opinion

  28 Nov 2012

• REC opinion

  Further Information Favourable Opinion