Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Semaglutide Injection - 2 mg/3 mL (0.68 mg/mL) pre-filled pen, 4 mg/3 mL (1.34 mg/mL) pre-filled pen and 8 mg/3 mL (2.68 mg/mL) pre-filled pen - (All Manufactured by Precise Biopharma P
Sponsors
Precise Biopharma Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex, aged 18 to 65 years (both inclusive) and ready to give written informed consent to participate in the study. 2. 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. 3. 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. 4. 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]. 5. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening. 6. Patients willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients with history of hypersensitivity to any of the study drug or to drugs of similar chemical classes. 2. Patients with fasting plasma glucose (FPG) greatet than or equal to 270 mg/dL at screening. 3. 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)]. 4. Patients with history or presence of acute pancreatitis within the past 180 days prior to the screening visit. 5. Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC). 6. Patients with serum calcitonin level greater than or equal to 50 ng/L at screening. 7. Patients with a known history of pancreatitis (acute or chronic).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline at the end of Week 24.Timepoint: Baseline and Week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline at the end of Week 4, 8, 12, 16 and 20.Timepoint: 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.Timepoint: 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.Timepoint: 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.Timepoint: 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.Timepoint: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24.;Number of patients receiving rescue medications.Timepoint: 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.Timepoint: 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.Timepoint: 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.Timepoint: Throughout the study.;Number of patients requiring hypoglycaemia management.Timepoint: Throughout the study.;Number of patients discontinued due to AEs during course of trial.Timepoint: 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 â?? visit 2).Timepoint: Day 0 and Week 24. | — |
Countries
India
Contacts
Public ContactMr Vipen Seth
Clinwave Research Pvt. Ltd.
Outcome results
None listed