Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Semaglutide Injection pre-filled pen: A dose of 0.25 mg, 0.5mg, 1.0 mg and 2.0 mg will be injected subcutaneously in the abdomen or in the thigh or in the upper arm once weekly for 24
Sponsors
Emcure Pharmaceuticals Ltd., India
Eligibility
Inclusion criteria
Inclusion criteria: 1) Subjects with diagnosis of type 2 diabetes mellitus for at least 6 months at screening visit. 2) Subjects with glycosylated haemoglobin (HbA1c) levels of greater than or equal to 7.0 percent to less than or equal to 10.5 percent. 3) Subject with stable on anti-diabetic drug therapy (daily dose of metformin greater than or equal to 1500 mg or maximum tolerated dose) within 12 weeks of screening visit. 4) Subjects willing to follow diet and exercise guidelines. 5) Subject with ability to understand and provide written informed consent form, which must have been obtained prior to screening. 6) Subjects willing to comply with the protocol requirements. 7) Subjects and their female partners of childbearing potential should agree to use contraceptive measures throughout the study and for at least 2 months after end of study. (Note: Acceptable methods of contraception: A. Male: Vasectomy, Condoms, Total abstinence; B. Females: hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception, intrauterine devices, intrauterine hormone releasing system, bilateral tubal occlusion, or total 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) Known or suspected hypersensitivity to investigational product(s) or related products. 2) Subjects with a history of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus. 3) Subjects with a history of metabolic acidosis or diabetic ketoacidosis. 4) Subjects with Fasting Plasma Glucose (FPG) greater than or equal to 270 mg/dL at screening. 5) Subjects with the Body Mass Index (BMI) greater than or equal to 45.0 kg/m2 at screening. 6) Serum Calcitonin level greater than or equal to 50 ng/L at screening. 7) Treatment with any glucose lowering agent(s) other than metformin in a period of 90 days prior to screening. An exception is short-term treatment (no longer than 7 days in total) with insulin in connection with inter-current illness. 8) Subjects with uncontrolled and potentially unstable diabetic retinopathy, maculopathy, neuropathy and nephropathy. 9) Subjects with uncontrolled hypertension with sitting systolic BP greater than or equal to 160 mmHg and/or diastolic BP greater than or equal to 100 mmHg at screening. 10) Subjects with any abnormality on 12-lead ECG at screening that in the opinion of the Investigator is clinically significant and is judged as potential risk for his/her participation in the study. 11) Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC). Family is defined as a first degree relative. 12) History or presence of pancreatitis (acute or chronic). 13) Subject who have undergone bariatric surgery within 12 months prior to screening. 14) Subjects who have acute coronary syndrome or cerebrovascular event (except old lacunar infarction) within 3 months before screening, including but not limited to acute myocardial infarction, unstable angina, stroke/transient cerebral ischemia attack, or have undergone heart-related surgery (including coronary artery bypass grafting, percutaneous coronary intervention) within 3 months before screening or any other cardiovascular/cerebrovascular diseases that are not suitable for participating in this trial. 15) Subjects presently classified as being in New York Heart Association (NYHA) Class III or IV. 16) Planned coronary, carotid or peripheral artery revascularization known on the day of Screening Visit. 17) Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2 as calculated on MDRD formula. 18) Subjects with alanine aminotransferase (ALT) and AST greater than 3 x upper limit of the normal (ULN); hemoglobin less than 9 g/dL, WBC count less than 2500/mm3 (less than 2.5 19) History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) before screening. 20) Subjects with a history of or diagnosis of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder etc.). 21) Proliferative diabetic retinopathy or maculopathy requiring acute treatment. 22) Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on a frequent basis) known to affect weight or glucose metabolism (e.g., Orlistat, thyroid hormones, corticosteroids) 23) Subjects diagnosed with HIV, HBV, and HCV 24) Any condition (e.g. infection, trauma, and surgery) which require insulin therapy at t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in HbA1c from baseline.Timepoint: Baseline and Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in HbA1c levelsTimepoint: Baseline, week 4, week 8, week 12, week 16 and week 20;Change in Fasting Plasma Glucose (FPG)Timepoint: Baseline, week 4, week 8, week 12, week 16, week 20 and week 24;Change in Postprandial Glucose (PPG)Timepoint: Baseline, week 4, week 8, week 12, week 16, week 20 and week 24;Change in body-weight and BMITimepoint: Baseline, week 4, week 8, week 12, week 16, week 20 and week 24;Change in Systolic and Diastolic blood pressure.Timepoint: Baseline, week 4, week 8, week 12, week 16, week 20 and week 24;Change from Baseline in Fasting Lipid Profile ParametersTimepoint: Baseline, Weeks 12 and 24;Proportion of subjects who achieve of HbA1c below 7.0%Timepoint: After 24 weeks of treatment.;Proportion of subjects receiving rescue medicationsTimepoint: Throughout the study period | — |
Countries
India
Contacts
Public ContactDr Milan Satia
Ethicare Clinical Trial Services (OPC) Pvt. Ltd.
Outcome results
None listed