Efficacy and Safety of Basal Insulin Glargine Combination With Exenatide Bid vs Aspart30 in T2DM

What Was Tested

The trial (phase 4) is built around Exenatide and Insulin Glargine.

It had two arms (groups): glargine + exenatide (experimental) and aspart 30 (active comparator).

Type 2 diabetic patients with inadequate glycaemic control on premixed human insulin and metformin previously. After a 12-week run-in period , switching premix human insulin to glargine ( once-daily subcutaneous injection at bedtime) combination with exenatide (subcutaneous injection, twice-daily).

Type 2 diabetic patients with inadequate glycaemic control on premixed human insulin and metformin previously. After a 12-week run-in period , switching premix human insulin to aspart 30 ( subcutaneous injection, twice daily).

The registry classes the interventions as drug.

More on the Plan

Approximately 248 patients will be enrolled in the study from China and randomized in a 1:1 ratio to one of the 2 treatment arms: once-daily insulin glargine + twice-daily exenatide + metformin; or twice-daily aspart 30 + metformin.

Study treatment will continue for 24 weeks.

The study consists of 3 periods: a 1-week screening (period A), a 12-week run-in period (period B) and a 24-week treatment period (period C).

Who Took Part

Enrollment: 349 actual participants took part.

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: Provision of informed consent. Men and women (non-pregnant and using a medically approved birth-control method) aged ≥ 18 and ≤ 70 years. BMI ≥ 23 and ≤ 35 kg/m2.

The full record lists 5 inclusion and 18 exclusion criteria; among the exclusions: type 1 diabetes or other specific types of diabetes; uncooperative subject because of various reasons; abnormal liver function, glutamic-pyruvic transaminase (alt) and glutamic-oxaloacetic transaminase (ast) \> twice the upper limits of normal.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2015-08 with completion listed for 2017-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: the absolute change in HbA1c from baseline to 24-week endpoint of basal insulin glargine combination with exenatide bid vs. switching to aspart30 in type 2 diabetic patients inadequately controlled on premixed human insulin and metformin (time frame: from baseline to 24-week endpoint).

It also tracked 6 secondary outcomes, for example Change in HbA1c from baseline to 12 weeks endpoint, Fasting blood glucose, Daily insulin use, Change in body weight and The incidence and rate of hypoglycaemic events during the study.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide and Insulin Glargine in 349 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page and the Insulin Glargine compound page, all human trials.