A Study of TG103 Injection in Type 2 Diabetes Subjects

NCT05348122 | Unknown Phase 2

• 1 other identifier: SYSA1803-008
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial is to evaluate the efficacy of different doses and frequencies of administration of TG103 injection in the treatment of type 2 diabetes.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Changes in glycosylated hemoglobin (HbA1c) from baseline to week 17

  Changes in glycosylated hemoglobin (HbA1c) from baseline to week 17

  Baseline through Day 113

Secondary Outcomes (11)

• Changes in glycosylated hemoglobin (HbA1c) from baseline to week 9

  Baseline through Day57

• The percentage of HbA1c≤6.5% and the percentage of HbA1c≤7% at week 9 and 17

  Day57 and 113

• Change in fasting plasma glucose (FPG) from baseline to week 9 and 17

  Baseline through Day57 and 113

• Change in weight from baseline to week 9 and 17

  Baseline through Day57 and 113

• Mean postprandial blood glucose increment and change in mean postprandial blood glucose from baseline at 7-point Self-monitored Blood Glucose (SMBG) Profile.

  Baseline through Day113

Study Arms (7)

TG103, 15 mg,Q2W

EXPERIMENTAL

TG103 (15 mg) will be administered via subcutaneous injection once every two weeks in subjects with type 2 diabetes.

Drug: TG103,Q2W

TG103, 22.5 mg,Q2W

EXPERIMENTAL

TG103 (22.5 mg) will be administered via subcutaneous injection once every two weeks in subjects with type 2 diabetes.

Drug: TG103,Q2W

Placebo,Q2W

PLACEBO COMPARATOR

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

Drug: Placebo,Q2W

TG103, 7.5 mg,QW

EXPERIMENTAL

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

Drug: TG103,QW

TG103, 15 mg,QW

EXPERIMENTAL

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

Drug: TG103,QW

Placebo,QW

PLACEBO COMPARATOR

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

Drug: Placebo,QW

Dulaglutide,QW

ACTIVE COMPARATOR

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

Drug: Dulaglutide,QW

Interventions

TG103,Q2W DRUG

TG103 injection will be administered via subcutaneous injection once every two weeks in subjects with type 2 diabetes.

Also known as: TG103 injection, subcutaneous injection,Q2W

TG103, 15 mg,Q2W; TG103, 22.5 mg,Q2W

TG103,QW DRUG

TG103 injection will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes.

Also known as: TG103 injection, subcutaneous injection,QW

TG103, 15 mg,QW; TG103, 7.5 mg,QW

Placebo,Q2W DRUG

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

Also known as: Placebo, subcutaneous injection,Q2W

Placebo,Q2W

Placebo,QW DRUG

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

Also known as: Placebo, subcutaneous injection,QW

Placebo,QW

Dulaglutide,QW DRUG

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

Also known as: Dulaglutide,subcutaneous injection,QW

Dulaglutide,QW

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of type 2 diabetes ;
• Aged 18 to 75 years (inclusive), no gender limitation;
• Body Mass Index (BMI): 18.5≤BMI≤40;
• Poor blood glucose control after diet and exercise alone without hypoglycemic drug treatment. Not treated with hypoglycemic drugs is defined as:Have not received hypoglycemic drugs before screening, or have received hypoglycemic drugs before screening, but have not received hypoglycemic drugs within 8 weeks before screening; and continuous use of insulin for no more than 14 days (except gestational diabetes) and/or the continuous use of another hypoglycemic drug for no more than 4 weeks within 1 year prior to screening;
• HbA1c must meet the following criteria:Screening: 7.5% ≤ HbA1c ≤ 11.0% (Local laboratory);Baseline: 7.0% ≤ HbA1c ≤ 10.5% (Central laboratory)
• 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;
• 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.

You may not qualify if:

• Type 1 diabetes;
• Body weight change more than 5% within 1 month prior to screening;
• Receive 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 or before randomization;
• 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;
• 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, or acute or chronic pancreatitis prior to randomization;
• 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 prior to randomization, long-term use of drugs that directly affect gastrointestinal motility, or gastrointestinal surgery that affects gastric emptying;
• Any of the following cardiovascular events within 6 months prior to screening, or prior to randomization: unstable angina pectoris, myocardial infarction, coronary artery bypass grafting, coronary stent implantation, moderate or severe congestive heart failure (NYHA grade III or IV), atrial or ventricular arrhythmia (e.g., atrial fibrillation, ventricular tachycardia, etc.), pacemaker or defibrillator implantation; Or subjects with Ⅱ or Ⅲ degree atrioventricular block, long QT syndrome or prolonged QTcF interval (QTcF: male \>450 ms, female \>470 ms) on 12-lead ECG, or signs of heart disease with significant clinical symptoms at screening;
• Hemorrhagic stroke or acute ischemic stroke disease occurred within 6 months prior to screening, or prior to randomization;
• Having a history of serious respiratory tract, central nervous system (such as epilepsy, etc.) and psychiatric diseases (such as depression, anxiety, etc.) during screening; Or have a history of other diseases that may endanger the safety of the subject and that the investigator deems inappropriate for enrollment;
• Any type of malignant tumor treated or untreated within 5 years prior to screening or prior to randomization (except clinically cured basal cell carcinoma or carcinoma in situ);
• Severe or acute infection within 4 weeks prior to screening, or refractory urinary tract or genital infection within 6 months prior to screening;
• Having a significant blood system disease (e.g., aplastic anemia, myelodysplastic syndrome) or any disease causing hemolysis or red blood cell instability (e.g., malaria) at screening or prior to randomization;
• Subjects with thyroid dysfunction that cannot be controlled by a stable drug dose at screening, or with clinically significant abnormalities in thyroid function examination results requiring drug treatment at screening ;

Sponsors & Collaborators

• CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Gao Huanhuan

Shijiazhuang, Hebei, 050035, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Linong Ji

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huanhuan Gao

CONTACT

+86-8031190343; lcgaohuanhuan@mail.ecspc.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 27, 2022
• Study Start: June 15, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: June 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)