A Phase III, Randomized, Open Label, Active Controlled, Prospective, Parallel Group, Comparative, Multicentric Clinical Study to Evaluate the Efficacy and Safety of Semaglutide Injection in Comparison with Reference Biologic Semaglutide Injection in Patients with Type 2 Diabetes Mellitus.
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 314
- Locations
- 30
- Primary Endpoint
- Change in HbA1c from baseline at the end of Week 24.
Study Overview
Brief Summary
A total of 314 patients with type 2 diabetes mellitus at geographically distributed centres in India will be enrolled in this clinical trial to evaluate the efficacy and safety of Semaglutide Injection compared to Reference Biologic Semaglutide Injection. Patients with type 2 diabetes mellitus with diet and exercise control, additionally on stable daily dose of Metformin (greater than or equal to 1500 mg or maximum tolerated dose based on clinical record) within 12 weeks prior to screening and with glycated haemoglobin (HbA1c) greater than or equal to 7.0 percent to less than or equal to 10.5 percent will be considered for enrollment in this study. The enrolled patients will be allocated to either of the 2 study groups according to the centralized computer-generated randomization plan in a 1:1 (test arm: comparator) ratio.
The patients with type 2 diabetes mellitus with diet and exercise control, additionally on stable daily dose of Metformin (greater than or equal to 1500 mg or maximum tolerated dose based on clinical record) within 12 weeks prior to screening will be screened (visit 1) within 2 weeks prior to their enrolment. The eligible patients will then be enrolled and randomized to either of the 2 study groups as per their randomization number on baseline visit (visit 2, week 0, day 0). After randomization, patients will then be followed up on an outpatient basis with scheduled visits at week 4 (visit 3), week 8 (visit 4), week 12 (visit 5), week 16 (visit 6), week 20 (visit 7) and week 24 (visit 8 – End of Treatment [EOT]). After 2 weeks of treatment, there will be a safety follow-up through telephonic visit at week 26 (visit 9 – End of Study [EOS]). This will be a parallel group study and all the enrolled patients will be instructed to take the study drugs for a treatment period of 24 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of either sex, aged 18 to 65 years (both inclusive) and ready to give written informed consent to participate in the study.
- •Patients with diagnosis of type 2 diabetes with glycosylated haemoglobin (HbA1c) greater than or equal to 7.0 percent and less than or equal to 10.5 percent.
- •Patients along with diet and exercise control additionally on stable daily dose of Metformin (greater than or equal to 1500 mg or maximum tolerated dose based on clinical record) within 12 weeks prior to the day of screening.
- •Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till last dose of the study medication (such contraception may include hormonal birth control e.g. combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or sexual abstinence).
- •[Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal.
- •Postmenopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age].
- •Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •Patients willing to comply with the protocol requirements.
Exclusion Criteria
- •Patients with history of hypersensitivity to any of the study drug or to drugs of similar chemical classes.
- •Patients with fasting plasma glucose (FPG) greatet than or equal to 270 mg/dL at screening.
- •Treatment with any medication for diabetes or obesity 90 days or less before screening [other than Metformin, or short-term insulin (less than or equal to 14 days in total)].
- •Patients with history or presence of acute pancreatitis within the past 180 days prior to the screening visit.
- •Patients with serum calcitonin level greater than or equal to 50 ng/L at screening.
- •Patients with a known history of pancreatitis (acute or chronic).
Outcomes
Primary Outcomes
Change in HbA1c from baseline at the end of Week 24.
Time Frame: Baseline and Week 24.
Secondary Outcomes
- Change in HbA1c from baseline at the end of Week 4, 8, 12, 16 and 20.(Baseline, Week 4, Week 8, Week 12, Week 16 and Week 20.)
- Change in Postprandial Glucose (PPG) from baseline at the end of Weeks 4, 8, 12, 16, 20 and 24.(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24.)
- Change in FPG from baseline at the end of Weeks 4, 8, 12, 16, 20 and 24.(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24.)
- Proportion of participants achieving HbA1c less than 7.0% at Weeks 8, 12, 16, 20 and 24.(Week 8, Week 12, Week 16, Week 20 and Week 24.)
- Change in body weight and BMI from baseline at the end of Week 4, 8, 12, 16, 20 and 24.(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24.)
- Number of patients receiving rescue medications.(Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24.)
- Change from baseline in fasting blood lipids (Total Cholesterol, LDL Cholesterol, HDL Cholesterol and Triglycerides) at Week 24.(Baseline and Week 24.)
- Change in systolic and diastolic blood pressure from baseline at the end of Week 4, 8, 12, 16, 20 and 24.(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24.)
- Adverse events and Serious adverse events (SAE) reported during the study.(Throughout the study.)
- Number of patients requiring hypoglycaemia management.(Throughout the study.)
- Number of patients discontinued due to AEs during course of trial.(Throughout the study.)
- Proportion of patients with anti-drug antibodies (ADA) and Neutralizing Antibody (Nab) at week 24 compared to pre-dose (enrolment, Day 0 – visit 2).(Day 0 and Week 24.)
Investigators
Dr Rajasekhara Reddy Tamma
Clinwave Research Pvt. Ltd.