CTRI/2025/08/093304 [Registered on: 20/08/2025] Trial Registered Prospectively
Last Modified On:
26/02/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
To Evaluate the Efficacy, Safety and Tolerability of semaglutide injection in adult with Type 2 Diabetes Mellitus.
Scientific Title of Study
A Randomised, Multicentric, Open Label, Prospective, Interventional, Active Controlled, Parallel Group, Phase-III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Semaglutide Injection Manufactured by Emcure Pharmaceuticals as Compared to Semaglutide Injection (Ozempic®) of Novo Nordisk A/S, in Subjects with Type 2 Diabetes Mellitus.
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Semaglutide Injection (Ozempic®)
A dose of 0.25 mg, 0.5mg, 1.0 mg and 2.0 mg will be injected subcutaneously in the abdomen, in the thigh or in the upper arm once weekly for 24 weeks at any time of the day, with or without meals.
Intervention
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 weeks at any time of the day, with or without meals.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
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.
ExclusionCriteria
Details
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 the time of screening or during the study period.
25) Subjects 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.
26) Pre-planned surgery or medical procedure that would interfere with the conduct of the study.
27) Subjects with known alcohol or other substance abuse within last one year of screening.
28) 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.
29) A lifetime history of a suicidal attempt.
30) Subjects with a history of suicidal behaviour or suicidal ideation within 30 days before screening.
31) Subjects having Hamilton Depression Rating Scale (HAM-D; 17 items) total score greater than or equal to 10, and/or a score of less than or equal to 2 on Suicide item of HAM-D 17-items scale at screening.
32) Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using or willing to use adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the follow-up period.
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This study will be conducted to evaluate the Efficacy, Safety and Tolerability of Semaglutide injection manufactured by Emcure Pharmaceuticals as compared to Semaglutide injection (Ozempic®) of Novo Nordisk A/S, in subjects with Type 2 diabetes mellitus. Subjects who meet all inclusion criteria and none of the exclusion criteria based on medical history will be recruited in the study.
The purpose of the present trial is to compare Semaglutide injection with (Ozempic®) Semaglutide injection (subcutaneous) of Novo Nordisk A/S, in terms of glycemic control, weight loss and other efficacy and safety parameters in subjects with T2DM. The study will be conducted at multiple centers across India.