A research study to compare two types of insulin, a new insulin, insulin icodec and an available insulin, insulin glargine, in people with type 2 diabetes who have not used insulin before
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2020/12/029545
- 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. Male or female aged above or equal to 18 years at the time of signing informed consent.
2. Diagnosed with T2D greater or equal to 180 days prior to the day of screening.
3. HbA1c from 7.0-11.0% (53.0-96.7 mmol/mol) both inclusive at screening confirmed by central laboratory analysis.
4. Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
5. Stable daily dose(s) greater or equal to 90 days prior to the day of screening of any of the following anti-diabetic
drug(s) or combination regimen(s):
a. Any metformin formulations greater or equal to 1500 mg or maximum tolerated or effective dose.
b. Any metformin combination formulations greater or equal to 1500 mg or maximum tolerated or effective
dose.
c. Any of the following oral anti-diabetic drug classes including combinations (greater or equal to half of the maximum approved dose according to local label or maximum tolerated or effective
dose):
Sulfonylureas
Meglitinides (glinides)
DPP-4 inhibitors
SGLT2 inhibitors Thiazolidinediones
Alpha-glucosidase inhibitors
Oral combination products (for the allowed individual oral anti-diabetic drugs)
Oral or injectable GLP-1 receptor agonists
6. Body mass index (BMI) lesser or equal to 40.0 kg/m2
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 childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice). 4. Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening. 5. Any disorder, except for conditions associated with T2D, which in the investigatorâ??s opinion might jeopardise subjectâ??s safety or compliance with the protocol. 6. Any episodes of diabetic ketoacidosis within 90 days prior to the day of screening. 7. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening. 8. Chronic heart failure classified as being in New York Heart Association Class IV at screening. 9. Planned coronary, carotid or peripheral artery revascularisation
10. Renal impairment with estimated glomerular filtration rate value of less than 30 ml/min/1.73m2 at screening15 by central laboratory analysis. 11. Impaired liver function, defined as Alanine Aminotransferase greater or equal to 2.5 times or bilirubin greater or equal to 1.5 times upper normal limit at screening by central laboratory analysis. 12. Inadequately treated blood pressure defined as systolic greater or equal to 180 mmHg or diastolic greater or equal to 110 mmHg at screening. 13. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days and prior insulin treatment for gestational diabetes are allowed. 14. Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids). 15. 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. 16. Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, insitu carcinomas of the cervix, or in-situ prostate cancer) within 5 years prior to the day of screening. 17. Anticipated change in lifestyle affecting glucose control.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate the effect on glycaemic control of once weekly insulin icodec, in combination with non-insulin anti-diabetic drugs, in insulin naïve subjects with T2D. This includes comparing the difference in change from baseline in HbA1c between insulin icodec and insulin glargine after 52 weeks of treatment to a non-inferiority limit of 0.3%. <br/ ><br>Timepoint: 52 weeks <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method To compare parameters of glycaemic control and safety of once weekly insulin icodec with once daily insulin glargine, both in combination with non-insulin anti-diabetic drugs, in insulin naïve subjects with T2D. <br/ ><br>Timepoint: 83 weeks <br/ ><br>