Type-2 Diabetes; Adults with inadequate glycemic control on Metformin
Research type
Research Study
Full title
A 52-week International, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3bTrial with a Blinded 104-week Long -term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered with Dapagliflozin in Combination with Metformin Compared to Glimepiride in Combination with Metformin in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone.
IRAS ID
182015
Contact name
Ewan Pearson
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2014-003721-18
Duration of Study in the UK
3 years, 7 months, 25 days
Research summary
This is a phase 3 study designed to review the effect of existing Diabetes Type 2 treatments in a new combination; Saxagliptin and Dapagliflozin with standard treatment Metformin vs Glimepiride with standard treatment Metformin in order to evaluate whether they are a more effective treatment for those who have had inadequate glycemic control on Metformin alone.
The study is a double blind study, which means neither sponsor, patient or doctor will know which treatment is being received, it is also active controlled. The study is split into 4 sections, Screening – to check for eligibility, Lead-In, Short–Term blinded treatment, Long-term blinded treatment.
Overall the study will last for 3 years with the screening and lead-in being up to 4 weeks prior to this. Potential patients would be expected to attend the research site approximately 20 times over the 3 years. After completing screening and lead-in, 2 weeks each, they would be assigned to 1 of the 2 treatments arms, listed above, and return for regular check-ups to monitor their response. Participants completing the short-term blinded treatment, over a 52 week period, will be assessed for eligibility for the long-term treatment period, 104 weeks.
Tests undertaken will include but are not limited too; physical exam, vital signs, height, weight, diet counselling, glucose metre monitoring, the keeping of a diary on diet and exercise, blood and urine tests.In order to be eligible to participate potential patients must fit the eligibility criteria; signing of a consent for to participant, a series of blood and urine tests to confirm certain levels on glycemic control, already be taking ≥1500mg Metformin for at least 8 weeks prior to screening, have a BMI of 20.0 to 45.0kg.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
15/YH/0309
Date of REC Opinion
19 Oct 2015
REC opinion
Further Information Favourable Opinion