Research study to compare three doses (14mg, 25mg & 50mg) of semaglutide tablets taken once daily in people with type 2 diabetes
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2021/02/031561
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Subjects are eligible to be included in the trial only if all of the following criteria apply
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 above or equal to 18 years at the time of signing informed consent.
3.Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening
4.HbA1c of 8.0-10.5 percentage (64 to 91 mmol/mol) (both inclusive).
5.BMI greater than or equal to 25.0 kg/m2
6.Stable daily dose for 90 days prior to the day of screening of any of the following treatment regimens
No more than 3 of the following oral anti-diabetic drugs and at least 1 marked with a
Metformin (=1500 mg or maximum tolerated or effective dose).
Sulfonylureas (SU) (=half of the maximum approved dose according to local label or maximum tolerated or effective dose).
SGLT2 inhibitors (maximum tolerated dose).
DPP-4 inhibitors (maximally indicated dose as per local label).
7.Subjects, on treatment with stable dose of DPP-4 inhibitors at inclusion, must be willing to terminate DPP-4 inhibitor treatment at randomisation (with no wash-out)
Subjects are excluded from the trial if any of the following criteria apply:
1.Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short-term insulin treatment for a maximum of 14 days prior to the day of screening is allowed.
2.Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect body weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids).
3.Renal impairment measured as estimated glomerular filtration rate (eGFR) value of <30 mL/min/1.73 m2 according to CKD-EPI creatinine equation as defined by KDIGO 2012 classification.
4.Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
5.History of major surgical procedures involving the stomach potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
6.Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
7.Presence or history of pancreatitis (acute or chronic).
8.Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
9.Presently classified as being in New York Heart Association (NYHA) Class IV.
10.Planned coronary, carotid or peripheral artery revascularisation.
11.Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.
12.Known or suspected hypersensitivity to trial products or related products.
13.Previous participation in this trial. Participation is defined as signed informed consent.
14.Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
15.Participation in any clinical trial of an approved or non-approved investigational medicinal product within 3 months before screening.
16.Other subject(s) from the same household participating in any oral semaglutide trial
17.Any disorder, unwillingness or inability, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in glycated haemoglobin (HbA1c) <br/ ><br>Timepoint: baseline (week 0) to week 52
- Secondary Outcome Measures
Name Time Method Achievement of HbA1c 7% (Yes/No) <br/ ><br>Timepoint: At week 52;Achievement of HbA1c =6.5% (Yes/No)Timepoint: At week 52;Achievement of weight loss =10% (Yes/No)Timepoint: At week 52;Achievement of weight loss =5% (Yes/No)Timepoint: At week 52;Adverse eventsTimepoint: baseline (week 0) to follow-up visit (week 73);Change in body weightTimepoint: baseline (week 0) to week 52;Change in fasting plasma glucose (FPG)Timepoint: baseline (week 0) to week 52;Change in waist circumferenceTimepoint: baseline (week 0) to week 52;Relative change in body weightTimepoint: baseline (week 0) to week 52