Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Semaglutide Injection 0.25 mg, 0.5 mg, 1 mg, 2 mg: Test product will be administered once weekly at any time of day, with or without meals for 24 weeks
Control Intervention1: Reference
Sponsors
Sun Pharmaceutical Industries Limited
Sun Pharmaceutical Industries Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients of either gender, aged 18 to 65 years (both inclusive) and ready to give written informed consent to participate in the study. 2) Patients with diagnosis of T2DM with HbA1c =7.0% and =10.5% 3) Patients along with diet and exercise control, additionally on stable daily dose of metformin (=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 the 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]
Exclusion criteria
Exclusion criteria: 1) Patients with history of hypersensitivity to any of the study drug or its excipients or to drugs of similar chemical classes 2) Patients with Fasting Blood Glucose (FBG) greater than or equal to 270 mg/dL at screening 3) Treatment with any medication for diabetes or obesity 90 days or less before screening 4) History of pancreatitis (acute or chronic) 5) Any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischemic attack within the past 180 days prior to the day of screening 6) Patients presently classified as being in New York Heart Association (NYHA) Class III or IV 7) Patients with planned coronary, carotid or peripheral artery revascularisation known on the day of screening 8) Patients having significant renal or hepatic impairment. 9) History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) before screening 10) Patients diagnosed with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) 11) Patients diagnosed with type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes (e.g. Cushing syndrome or acromegaly-associated diabetes) 12) Patients with any clinically significant laboratory abnormalities/condition which in the opinion of Investigator would compromise the well-being of the patient or the conduct of the study, or prevent the patient from meeting or performing study requirements 13) Pre-planned surgery or medical procedure that would interfere with the conduct of the study 14) Patients with known alcohol or other substance abuse within last one year of screening 15) Employee of the Sponsor, Investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees of Sponsor or the Investigator 16) Pregnant, lactating women or women who intends to conceive or women of childbearing age who are not willing to use an acceptable method of birth control during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in HbA1cTimepoint: Timeframe: Baseline, Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in HbA1c levelsTimepoint: Timeframe: Baseline, Weeks 4, 8, 12, 16, and 20;Change from Baseline in FBG levelsTimepoint: Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24;Change from Baseline in PPBG levelsTimepoint: Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24;Change from Baseline in Bodyweight and BMITimepoint: Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24;Change from Baseline in Systolic and Diastolic Blood PressureTimepoint: Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24;Change from Baseline in Fasting Lipid Profile ParametersTimepoint: Timeframe: Baseline, Weeks 8 and 24;Proportion of patients achieving HbA1c less than 7.0%Timepoint: Timeframe: Baseline, Weeks 8, 12, 16, 20 and 24;Proportion of patients receiving rescue medicationsTimepoint: Timeframe: Throughout the study period;Incidence of TEAEs and SAEsTimepoint: Throughout the study period;Proportion of patients requiring hypoglycaemia managementTimepoint: Timeframe: Throughout the study period;Proportion of patients with ADA and NAbTimepoint: Timeframe: Baseline (Pre-dose), Week 24] | — |
Countries
India
Contacts
Public ContactDr Rajiv Yadav
Sun Pharma Laboratories Limited
Outcome results
None listed