Type 2 Diabetes
Conditions
Keywords
Glucagon-Like Peptide-1 Receptor Agonists, semaglutide
Brief summary
This is a 32-week randomized, open-label, parallel-controlled biosimilar comparison study comparing the efficacy, safety and immunogenicity of the investigational drug and the active comparator in patients with type 2 diabetes mellitus who have inadequate glycemic control with metformin. Eligible participants will be screened and randomized to the experimental group and the active comparator group at a ratio of 1:1 , semaglutide injection or Ozempic® injection abdominal subcutaneous injection will be given according to their groups weekly for 32 weeks. Follow-up for 4 weeks after administration. Trial product will be add-on to subject's stable pre-trial metformin. The study included a screening period (up to 2 weeks), run-in period（6 weeks），baseline, administration period(32 weeks), and a follow-up period (4 weeks). The duration of the study will be approximately 44 weeks for a participant.
Interventions
DRUGOzempic®
The starting dose is 0.25 mg once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly for 24 weeks.
DRUGHDG1901
The starting dose is 0.25 mg once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly for 24 weeks.
Sponsors
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female, age 18-75 years (both inclusive) at the time of signing informed consent 2. Subjects diagnosed with type 2 diabetes and on stable treatment in a period of 6 weeks prior to screening with metformin ≥ 1500 mg (or maximum tolerated dose ≥ 1000 mg) 3. HbA1c 7.5 - 11.0 % (both inclusive) (screening) 4. HbA1c 7.0 - 10.5 % (both inclusive) (randomisation) 5. BMI 18.5-35 kg/m2 (both inclusive)
Exclusion criteria
1. Other types of diabetes besides Type 2 diabetes 2. A history of acute diabetes complications within 6 months before screening 3. A history of acute or chronic pancreatitis, symptomatic gallbladder disease, or other high-risk factors that may lead to pancreatitis 4. Personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) 5. Acute coronary or cerebrovascular event within 3 months before screening or randomisation 6. Heart failure, New York Heart Association (NYHA) class IV 7. Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 6 weeks before screening. An exception is short-term treatment (≤7 days in total) with insulin in connection with inter-current illness 8. Fasting Plasma Glucose (FPG) ≥ 13.9mmol/L 9. Screening calcitonin value ≥ 35 ng/L (pg/mL) 10. Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m2 11. Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline | Week 32 |
Secondary
| Measure | Time frame |
|---|---|
| Change in Fasting Plasma Glucose(FPG) from baseline | Week 20， Week 32 |
| HbA1c ≤ 6.5% | Week 20, Week 32 |
| Change in HbA1c from baseline | Week 20 |
| C-peptide | Week 20, Week 32 |
| Insulin | Week 20, Week 32 |
| HbA1c ≤ 7.0% | Week 20，Week 32 |
Countries
China
Outcome results
None listed