Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Randomized, Open, Controlled, Parallel Group Study of Adding Linagliptin to Control Glycemic Variability and HbA1c in Peritoneal Dialysis Patients With Type 2 Diabetes(PDPD) With Premixed Insulin Therapy
In china, there are the most population of type 2 diabetes mellitus (DM) among the world and
DM becomes currently the second cause for end-stage renal disease (ESRD). Nearly 50% of
insulin-treated PD patients in clinical practice are treated with premixed insulin. Glycemic
control in them is very difficult to be achieved mainly due to the uremic status of these
patients and glucose exposure from peritoneal dialysate, a higher glycemic variability and
higher risk of hypoglycemia. Linagliptin, unlike other DPP-4 inhibitors, has a primarily
non-renal elimination route, and does not require dose adjustment for any level of impaired
renal function. The aim of this study is to evaluate the effect of linagliptin on glucose
variability and glycemic control in peritoneal dialysis patients with type 2 diabetes who are
inadequately controlled with premixed insulin therapy.
This will be a randomized, double-blind, placebo-controlled, parallel group study to evaluate
the effect of linagliptin on glucose variability and glycemic control in peritoneal dialysis
patients with type 2 diabetes who are inadequately controlled with premixed insulin
therapy.which will be conducted in 8 diabetes centres and/or nephropathy departments in
China. After a 4-week run- in period, 232 participants are randomized (1:1) to either
premixed insulin combined with linagliptin (5mg/d) group (also named combined group) or
premixed insulin alone group (also named insulin group) for 12 weeks. Finally, the primary
endpoint is glucose variability indicated by MAGE, secondary endpoints include HbA1c, FPG,
PPG, LAGE, SDBG, PT10.0, PT3.9, 1h fasting MBG, 3h postprandial MBG, insulin dosage,
hypoglycemia and body weight.
n/a
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