A 26-week trial comparing the effect and safety of once weekly insulin icodec and once daily insulin glargine 100 units/mL, both in combination with bolus insulin with or without non-insulin anti-diabetic drugs, in subjects with type 2 diabetes on a basal-bolus regimen.
- Conditions
- diabetesDiabetes Mellitus type 210018424
- Registration Number
- NL-OMON54981
- Lead Sponsor
- ovo Nordisk
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
- Male or female aged above or equal to 18 years at the time of signing
informed consent.
- Diagnosed with T2D * 180 days prior to the day of screening.
- HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol) both inclusive at screening
confirmed by central laboratory analysis.
- Treated with once daily basal insulin (neutral protamine hagedorn insulin,
insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin
glargine 300 units/mL) and 2-4 daily injections of bolus insulin analog
(insulin aspart, faster acting insulin aspart, insulin lispro, faster acting
insulin lispro, insulin glulisine) * 90 days prior to the day of screening with
or without any of the following anti-diabetic drugs/regimens with stable doses
* 90 days prior to screening:
* Metformin
* 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 RAs
- Body mass index (BMI) * 40.0 kg/m2
- Any episodes (as declared by the subject or in the medical records) of
diabetic ketoacidosis within 90 days prior to the day of screening.
- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris
or transient ischaemic attack within 180 days prior to the day of screening.
- Chronic heart failure classified as being in New York Heart Association Class
IV at screening.
- 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).
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change in HbA1c (%) from baseline week 0 (V2) to week 26 (V28)</p><br>
- Secondary Outcome Measures
Name Time Method