The Effect of Saxagliptin on Glucose Fluctuation and Immune Regulation in Patients With Type 1 Diabetes

What Was Tested

In this phase 4 trial, researchers set out to test Insulin (regular human).

It had two arms (groups): insulin+Saxagliptin (experimental) and insulin (active comparator).

Patients who have diagnosed type 1 diabetes only use insulin.

The registry classes the interventions as drug.

More on the Plan

Type 1 diabetes mellitus (T1DM) is characterized by immune mediated beta-cell destruction.

Due to the imbalance between glucagon and insulin, long-term T1DM patients experience frequent hypoglycaemia and high glucose variability despite of multiple daily injections of insulin.

In type 1 diabetic mouse models, DPP-4 inhibitors preserves beta-cell mass and stimulating beta-cell replication.

Interestingly, DPP-4 is also known as cluster of differentiation antigen 26(CD26).It is expressed on the membrane of many types of lymphocyte, e.g.

Who Took Part

184 planned participants were the target.

It was open to people of any sex aged from 12 years up to 65 years.

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

Examples of who could join: Provision of informed consent prior to any study specific procedures;. Diagnosed with type 1 diabetes;. Men or women who are 12 to 65 years of age at time of consenting upon Visit 1.;. Positivity for at least one of the four islet autoantibodies(IA-2A、IAA、GADA、ZnT8A);.

The full record lists 5 inclusion and 23 exclusion criteria; among the exclusions: type 2 diabetes；; evidence of chronic or acute complications of diabetes which is unstable and requires hospitalization；; evidence of disease stress；.

How the Study Was Run

Design: 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 2014-11 with completion listed for 2017-03.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change of Mean amplitude of glycemic excursions (MAGE) from baseline in patients with type 1 diabetes treated with saxagliptin plus insulin or insulin alone by continuous glucose monitoring system (CGMS) (time frame: 24 week).

It also tracked 3 secondary outcomes, for example Change of Haemoglobin A1c (HbA1c) from baseline in patients with type 1 diabetes treated with saxagliptin plus insulin or insulin alone.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 184 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.