A Study of TG103 Injection Combined With Metformin in Treatment of Type 2 Diabetes Mellitus

What Was Tested

In this phase 3 trial, researchers set out to test Dulaglutide.

It had three arms (groups): one (experimental), one (experimental) and Dulaglutide (experimental).

Dulaglutide will be administered via subcutaneous injection once a week in subjects with type 2 diabetes.

The registry classes the interventions as drug.

Who Took Part

632 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Aged 18 to 75 years (inclusive), no gender limitation;. Body Mass Index (BMI): 18.5≤BMI≤40;. HbA1c must meet the following criteria:. Willing and able to accurately use home glucose meter for self-glucose monitoring;. Be able to understand and follow the trial procedure, voluntarily participate in the trial and sign the informed consent form.

The full record lists 10 inclusion and 39 exclusion criteria; among the exclusions: type 1 diabetes;; received any of the following medications:; systemic glucocorticoid and growth hormone,or other drugs affecting glucose metabolism have been used within 8 weeks before screening;.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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

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

As a double-blind Dulaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-04-08 with completion listed for 2026-02-03.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Changes in glycosylated hemoglobin (HbA1c) from baseline at 28 weeks of treatment (time frame: Baseline through Week28).

It also tracked 11 secondary outcomes, for example Changes in HbA1c from baseline at 52 weeks of treatment, Change in fasting plasma glucose (FPG) from baseline at week 28 and 52, Change in weight from baseline at week 28 and 52, Change in 2h-postprandial plasma glucose (2h-PPG) from baseline at week 28 and 52, Proportion of subjects receiving remedial therapy at week 28 and 52 and Incidence of adverse events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Dulaglutide in 632 people.

With 632 participants it is a large trial for this field.

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

More context: the Dulaglutide compound page, all human trials.