Efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes
- Conditions
- Health Condition 1: null- Type 2 Diabetes MellitusHealth Condition 2: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2016/05/006917
- Lead Sponsor
- ovo Nordisk India Private Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 117
1. Informed consent obtained before any trial-related activities. Trial-related activities are any
procedures that are carried out as part of the trial, including activities to determine suitability for
the trial
2. Male or female, age >= 18 years at the time of signing informed consent
3. Subjects with T2D diagnosed clinically >= 90 days prior to screening
4. HbA1c 7.0 â?? 10.5% (53 â?? 91 mmol/mol) (both inclusive)
5. Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal
tolerated dose documented in the patient medical record) for 90 days prior to screening
1. Known or suspected hypersensitivity to trial product(s) or related products
2. Previous participation in this trial. Participation is defined as signed informed consent
3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
4. Receipt of any investigational medicinal product within 90 days before screening
5. Any condition, which in the investigatorâ??s opinion might jeopardise subjectâ??s safety or
compliance with the protocol
6. Treatment with any medication for the indication of diabetes or obesity other than stated in the
inclusion criteria in a period of 90 days before screening. An exception is short-term insulin
treatment for acute illness for a total of <=14 days
7. History of pancreatitis (acute or chronic)
8. Screening calcitonin >=50 ng/L
9. Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid
Carcinoma
10. Renal impairment defined as eGFR 60 mL/min/1.73 m2 as per CKD-EPI
11. Any of the following: myocardial infarction (MI), stroke or hospitalisation for unstable angina
and/or transient ischaemic attack (TIA) within the past 180 days prior to the day of screening
12. Subjects presently classified as being in New York Heart Association (NYHA) Class IV
13. Planned coronary, carotid or peripheral artery revascularisation on the day of screening
14. Proliferative retinopathy or maculopathy requiring acute treatment
15. History or presence of malignant neoplasms within the last 5 years (except basal and squamous
cell skin cancer and in-situ carcinomas)
16. 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HbA1c <br/ ><br>Timepoint: 40 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method Change in body weightTimepoint: 40 weeks <br/ ><br>