To study the effect of a novel drug (Semaglutide) which has half-life of around 1 week, suitable for once-weekly injection compared with bolus pre-meal insulin 3 times daily, both added to metformin (oral anti-diabetic drug) & insulin glargine (long acting insulin) in patients with type 2 diabetes
- Conditions
- Health Condition 1: null- Type 2 Diabetes in adultsHealth Condition 2: E11- Type 2 diabetes mellitusHealth Condition 3: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2018/10/015916
- 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
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 more than or equal to 18 years at the time of signing informed consent.
3. Diagnosed with type 2 diabetes more than or equal to 180 days prior to the day of screening.
4. Treated with basal insulin once daily or twice daily for more than or equal to 90 days prior to the day of screening.
5. Stable daily dose for 90 days prior to the day of screening of the following anti-diabetic drugs or combination regimens- Any metformin formulations -more than or equal to 1500 mg to less than or equal to 3000 mg or maximum tolerated or effective dose documented in subjects medical record, alone or in combination -including fixed-dose drug combination with up to one additional of the following OADs- sulfonylureas, meglitinides, DPP-4 inhibitors or alpha-glucosidase inhibitors.
6. HbA1c of more than 7.5percent to less than or equal to 10.0percent- more than 58 mmolpermol to less than or equal to 86 mmolpermol.
7. The need and willingness to undergo treatment intensification with the treatments investigated in this trial with the aim to reach an HbA1c of 6.5 percent to 7.5 percent-48 mmolpermol to 58 mmolpermol-both inclusive, as assessed by the investigator.
8. Ability and willingness to adhere to the protocol including performance of SMPG profiles according to the protocol.
9. Ability and willingness to eat at least 3 meals -breakfast, lunch and dinner- every day during the trial.
1. Known or suspected hypersensitivity to trial products 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 highly effective contraceptive methods as required by local regulation or practice.
4. Receipt of any investigational medicinal product within 30 days before screening except from IGlar.
5. Any disorder which in the investigators opinion might jeopardise the subjects safety or compliance with the protocol.
6. Personal or first degree relatives history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
7. History or presence of pancreatitis-acute or chronic.
8. Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or
transient ischaemic attack within the past 180 days prior to the day of screening.
9. Subjects presently classified as being in New York Heart Association Class IV.
10. Planned coronary, carotid or peripheral artery revascularisation known on the day of
screening.
11. Renal impairment measured as estimated Glomerular Filtration Rate eGFR less than30 ml per min per1.73 m2 as defined by KDIGO 2012.13
12. 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 bolus insulin treatment for a maximum of 14 days prior to the day of screening is allowed.
13. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a
pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an
equally qualified health care provider ,e.g. optometrist within the past 90 days prior to runin.
14. Presence or history of malignant neoplasms within the past 5 years prior to the day of
screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the effect of semaglutide once-weekly on glycaemic control versus insulin aspart three times daily (TID), both as add on to metformin and optimised insulin glargine (U100) in subjects with T2D.Timepoint: After 52 weeks of treatment
- Secondary Outcome Measures
Name Time Method To demonstrate that semaglutide once-weekly has a lower risk of severe hypoglycaemic episodes compared to IAsp TID, both as add on to metformin and optimised insulin glargine (U100) in subjects with T2D. <br/ ><br>To compare the effect of semaglutide OW versus IAsp TID, both as add on to metformin and optimised insulin glargine (U100) in subjects with T2D with regards to: <br/ ><br>1. body weight <br/ ><br>2. lipids <br/ ><br>3. blood pressure <br/ ><br>4. health-related quality of life <br/ ><br>5. safetyTimepoint: After 52 weeks of treatment <br/ ><br>