A Study of TG103 Injection in Type 2 Diabetes Subjects

What Was Tested

This registered phase 2 trial tested Dulaglutide.

It had seven arms (groups): one (experimental), one (experimental), Placebo,Q2W (placebo comparator), one (experimental) and one (experimental).

Placebo will be administered via subcutaneous injection once every two weeks in subjects with type 2 diabetes.

The registry classes the interventions as drug.

More on the Plan

This trial is a randomized, double-blind, placebo-parallel, Dulaglutide-controlled，multicenter phase Ⅱ clinical trial.

The whole trial consists of two parts, Part A and Part B, and 240 subjects are planned to be enrolled.

After Part A enrollment is completed, Part B will continue to be enrolled.

The trial will include a screening period of up to 2 weeks, an initiation period of 2 weeks, a double-blind treatment period of 16 weeks, and a safety follow-up period of 3 weeks.

Who Took Part

240 planned participants were the target.

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: Clinical diagnosis of type 2 diabetes ;. Aged 18 to 75 years (inclusive), no gender limitation;. Body Mass Index (BMI): 18.5≤BMI≤40;. Must be 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 8 inclusion and 25 exclusion criteria; among the exclusions: type 1 diabetes;; history of grade 3 hypoglycemia ≥2 times within 6 months prior to screening, or grade 3 hypoglycemia prior to screening to randomization;; acute complications of diabetes, such as diabetic ketoacidosis and hyperglycemia, occurred ≥1 time within 6 months prior to screening, or prior to randomization;.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

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

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

Only one side, usually the participants, was kept unaware of whether Dulaglutide was given.

Those kept unaware of assignments: participant.

It started in 2022-06-15 with completion listed for 2023-11-01.

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 to week 17 (time frame: Baseline through Day 113).

It also tracked 11 secondary outcomes, for example Changes in glycosylated hemoglobin (HbA1c) from baseline to week 9, Change in fasting plasma glucose (FPG) from baseline to week 9 and 17, Change in weight from baseline to week 9 and 17, Change in 7-point Self-monitored Blood Glucose (SMBG) Profile, Proportion of subjects receiving remedial therapy at week 17 and Number of TEAEs and SAEs from baseline to week 17.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Dulaglutide in 240 people.

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

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