A Study of Adding Linagliptin to Control Glycemic Variability and HbA1c in Peritoneal Dialysis Patients With Type 2 Diabetes(PDPD) With Premixed Insulin Therapy

What Was Tested

The trial (phase 4) is built around Insulin Lispro.

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).

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.

It had two arms (groups): combined group (experimental) and linsulin group (active comparator).

Drug: premixed insulin Treated with premixed insulin for 12 weeks.

The registry classes the interventions as drug.

Who Took Part

The registry lists 232 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Type 2 diabetic patients who were treated with insulin regimen;. Ages eligible for study:18 years to 80 years;. The patients with end-stage kidney disease receiving a regular peritoneal dialysis for at least 3 months;. Body mass index ranging from 21 to 35 kg/m2.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: having any severe acute or chronic diabetic complications; blood aminotransferase level rising up more than 2 times of the upper normal limit; any severe cardiac disease, severe systemic diseases or malignant tumour.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Insulin Lispro group and the comparison group should start out alike.

The Insulin Lispro group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin Lispro study: the participants and staff both knew the treatment.

It started in 2017-06-03 with completion listed for 2019-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: glucose variability (time frame: 12 weeks).

It also tracked 5 secondary outcomes, for example HbA1c, FPG, body weight and hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Lispro in 232 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Lispro compound page, all human trials.