| Methods |
This was a randomised, placebo‐controlled, parallel‐group, double‐blind, multicentre, multinational study. Study duration was up to 69 weeks, including a 1‐week screening period, an 8‐week “wash‐off” period (for patients on oral glucose‐lowering agents at screening), a 2‐week single‐blind placebo run‐in period, a 54‐week double‐blind treatment period consisting of a 24‐week placebo‐controlled period (Phase A) and a 30‐week active‐controlled period (Phase B) and a post‐trial phone follow‐up 28 days after final dose |
| Participants |
Number: 213 patients Setting: multinational; 109 centres in Australia, North America, Europe, Asia, Israel and Russia Inclusion criteria: male or female ≥ 30 years with type 2 DM; moderate kidney impairment (eGFR ≥ 30 to < 60 mL/min/1.73 m2) or severe CKD (eGFR < 30 mL/min/1.73 m2), as determined by the MDRD formula, or ESKD on dialysis for at least 6 months; eligible patients were either (1) not on a glucose lowering agent (naive or off therapy for ≥ 12 weeks) with HbA1c ≥ 7.0% (53 mmol/mol) and ≤ 10.0% (86 mmol/mol); (2) on a single oral glucose lowering agent or low‐dose dual oral combination glucose lowering agents (i.e. at ≤ 50% of maximum labelled dose of each agent) with an HbA1c of ≥ 6.5% (48 mmol/mol) and ≤ 9.0% (75 mmol/mol); or (3) on a stable insulin regimen, at a dose of at least 15 U/d, for ≥ 10 weeks, with no oral glucose lowering agent and HbA1c ≥ 7.5% (58 mmol/mol) and ≤ 10.0% (86 mmol/mol) and FBG > 7.22 mmol/L, subjects on oral glucose lowering agents therapy had their medication discontinued (“washed‐off”) Exclusion criteria: type 1 DM; history of ketoacidosis; C‐peptide level < 0.7 ng/mL; active liver disease; significant CVD; a haematological disorder; a history of malignancy; treated with any incretin mimetic or thiazolidinedione within the prior 12 weeks of screening, or with omarigliptin at any time prior to signing informed consent |
| Interventions |
Treatment group
Control group
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| Outcomes |
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| Notes |
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