Therapies on Newly Diagnosed Type 2 Diabetes Patients With High Glucose Toxicity Which Protect Islet β Cell

What Was Tested

In this not phased trial, researchers set out to test Insulin (regular human).

It had three arms (groups): DPP4 group (experimental), insulin group (experimental) and SU group (placebo comparator).

DPP4 inhibitor,1 pill qd.

The registry classes the interventions as drug.

More on the Plan

Patients were divided into 3 groups: 1.

DPP-4 inhibitor treatment group (45 cases): DPP-4 inhibitor (sitagliptin phosphate) combined with metformin and/or acarbose; 2. insulin treatment group (45 cases): insulin (insulin glargine or insulin detemir) and/or metformin; 3.

Sulfonylureas treatment group (45 cases): sulfonylureas combined with metformin and/or acarbose;.

Who Took Part

The registry lists 135 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Type 2 diabetes. Urine ket ≦(1+). Normal liver and kidney function.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: type 1 diabetes; renal or hepatic insufficiency; severe ketoacidosis.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2017-07-01 with completion listed for 2020-01-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Fasting blood glucose,glycosylated hemoglobin(GHbA1c) (time frame: From date of randomization until the date of first documented progression, assessed up to 3 months).

It also tracked 3 secondary outcomes, for example weight loss, Lipid changes and Incidence of hypoglycemia.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 135 people.

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

More context: the Insulin (regular human) compound page, all human trials.