Sitagliptin vs. Dapagliflozin As Add-on to Metformin in Subjects with Mild Renal Impairment
Research type
Research Study
Full title
A Phase III, Multicenter, Randomized, Double-Blind, Active-Comparator Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Sitagliptin Compared with the Addition of Dapagliflozin in Subjects with Type 2 Diabetes Mellitus and Mild Renal Impairment Who Have Inadequate Glycemic Control on Metformin
IRAS ID
189499
Contact name
Leonid Dubrovsky
Contact email
Sponsor organisation
Merck Sharp & Dohme (UK) Limited
Eudract number
2014-005525-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 6 days
Research summary
This is a multicentre, randomized, double-blind clinical trial of sitagliptin compared to dapagliflozin in patients with type 2 diabetes mellitus (T2DM) and mild renal impairment and who have inadequate glycemic control on metformin monotherapy.
Each patient will participate in the trial for approximately 30 weeks (7 clinic visits). The study involves a 2-week Screening Period (Visit 1 to Visit 2); a 2-week run-in period (Visit 2 to Visit 3); a 24-week double-blind treatment period (Visit 3 to Visit 7); and a post-treatment telephone contact 14 days after the last dose of study drug.
Approximately 556 subjects ≥25 years of age with T2DM, with inadequate glycemic control on metformin monotherapy (≥1500 mg/day for ≥8 weeks) and with an estimated glomerular filtration rate (eGFR) ≥60 and <90 mL/min/1.73m2 will participate in the study. Patients who meet all enrollment criteria at visit 3, will be randomized in a 1:1 ratio to receive either sitagliptin (100mg once daily) or dapagliflozin (once daily) during the double-blind treatment period. Dapagliflozin/matching placebo will be initiated at 5 mg per day and titrated up to 10 mg at Visit 4/Week 4. Subjects are to remain on their stable dose of metformin (≥1500 mg/day) while receiving blinded study drug during the double-blind treatment period.
All subjects will undergo a mixed meal tolerance test (MMTT) at Visit 3 and at the end of the double-blind treatment period (Visit 7/Week 24 or Discontinuation Visit).
This trial is designed to evaluate, in adult subjects with T2DM and chronic mild renal impairment, the glycemic efficacy, safety, and tolerability of sitagliptin over a 24-week treatment period in comparison to that of dapagliflozin.
This study will take place at approximately 4 NHS sites in the UK and is funded by Merck, Sharp and Dohme Ltd.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
15/EM/0480
Date of REC Opinion
22 Dec 2015
REC opinion
Further Information Favourable Opinion