A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Trial of TG103 Injection Monotherapy Subjects With Type 2 Diabetes Mellitus

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.1 site in 1 country465 target enrollmentMarch 15, 2024

ConditionsType 2 Diabetes Mellitus

InterventionsTG103 Placebo

DrugsTG103 Placebo

Overview

Phase: Phase 3
Intervention: TG103
Conditions: Type 2 Diabetes Mellitus
Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Enrollment: 465
Locations: 1
Primary Endpoint: Changes in glycosylated hemoglobin (HbA1c)
Status: Active, not recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, double-blind, placebo-parallel, multicenter phase 3 clinical trial to evaluate the efficacy of TG103 injection 7.5mg and 15mg once a week monotherapy compared with placebo in subjects with type 2 diabetes with poor glycemic control after diet and exercise.

Registry

clinicaltrials.gov

Start Date

March 15, 2024

End Date

November 1, 2026

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•1.Subjects have diagnosed with type 2 diabetes according to the Guidelines for prevention and treatment of type 2 diabetes in China (2020 Edition), and have been diagnosed with T2DM for at least 8 weeks before screening;
•2.Aged 18 to 75 years (inclusive), no gender limitation;
•Body Mass Index (BMI): 18.5≤BMI≤40;
•No hypoglycemic drugs have been used within 8 weeks before screening, and the blood glucose control is poor after diet and exercise therapy alone
•5.The continuous use of insulin ≤14 days (except gestational diabetes), and/or the types of hypoglycemic drugs used in combination \<3 with the continuous use time ≤4 weeks within 1 year (more than 8 weeks) before screening;
•6.HbA1c must meet the following criteria:
•Screening: 7.5% ≤ HbA1c ≤ 11.0% (Local laboratory)
•Baseline: 7.0% ≤ HbA1c ≤ 10.5% (Central laboratory)
•7.Subjects of childbearing potential must use reliable methods of contraception throughout the study period and at least 3 months after the last dose to avoid pregnancy in female subjects or pregnancy in the male subject's partner;
•Willing and able to accurately use home glucose meter for self-glucose monitoring;

Exclusion Criteria

•Type 1 diabetes;
•Body weight change more than 5% within 1 month prior to screening;
•Received any of the following medications:
•Prior discontinuation of DPP-4 inhibitors or GLP-1 receptor agonists for efficacy, tolerability, and safety reasons;
•Systemic glucocorticoid and growth hormone have been used within 8 weeks before screening;
•History of ≥2 episodes of grade 3 hypoglycemia within 6 months prior to screening, or grade 3 hypoglycemia between screening to randomization;
•Acute complications of diabetes, such as diabetic ketoacidosis and hyperglycemic hyperosmolar status, occurred ≥1 time within 6 months prior to screening;
•Severe chronic complications of diabetes (e.g., proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot, etc.) within 6 months prior to screening
•History of acute or chronic pancreatitis prior to screening;
•Subjects with clinically significant gastric emptying abnormalities (e.g., gastric outlet obstruction), severe chronic gastrointestinal diseases (e.g., gastroparesis, inflammatory bowel disease, or intestinal obstruction) within 6 months prior to screening, or who have undergone gastrointestinal surgery that affects gastric emptying;

Arms & Interventions

TG103, 7.5 mg

TG103 (7.5 mg) will be administered via subcutaneous injection once a week in subjects with type 2 diabetes.

Intervention: TG103

TG103, 7.5 mg placebo

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

Intervention: Placebo

TG103, 15 mg

TG103 (15 mg) will be administered via subcutaneous injection once a week in subjects with type 2 diabetes.

Intervention: TG103

TG103, 15 mg placebo

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

Intervention: Placebo

Outcomes

Primary Outcomes

Changes in glycosylated hemoglobin (HbA1c)

Time Frame: Baseline through Week28

Secondary Outcomes

The percentage of HbA1c≤6.5% and the percentage of HbA1c≤7%(Week28 and 52)
Change in fasting plasma glucose (FPG)(Baseline through Week 28 and 52)
Change in weight(Baseline through Week 28 and 52)
Change in 2h-postprandial plasma glucose (2h-PPG)(Baseline through Week 28 and 52)
Change in mean 7-point blood glucose curve ， Change in mean postprandial blood glucose increment .(Baseline through Week 28 and 52)
Change in blood lipids (triglycerides, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol)(Baseline through Week 28 and 52)
Changes in HbA1c(Baseline through Week52)
Proportion of subjects receiving remedial therapy(Week 28 and 52)
Incidence of adverse events(Week-2 through 52)
Blood concentrations of TG103(Week 0, 4, 8,16, 28,36, 44,52 and 55)
The occurrence of TG103 anti-drug antibodies (ADA) and neutralizing antibody (NAb)(Week 0, 4, 8,16, 28,36, 44,52 and 55)