CTRI/2021/06/034231Active, not recruitingPhase 3
A research study to compare two types of insulin, a new weekly insulin, insulin icodec and an available daily insulin, insulin glargine, both in combination with mealtime insulin, in people with type 2 diabetes who use daily insulin and mealtime insulin. - ONWARDS 4
ovo Nordisk Denmark0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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.
- •3. Age above or equal to 18 years at the time of signing informed consent.
- •4. Diagnosed with T2D >= 180 days prior to the day of screening.
- •5. HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol) both inclusive at screening confirmed by
- •central laboratory analysis.
- •6. 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
- •Oral or injectable GLP-1 RAs
- •7. Body mass index (BMI) <= 40.0 kg/m2.
Exclusion Criteria
- •Subjects are excluded from the trial if any of the following criteria apply:
- •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. Participation in any clinical trial of an approved or non-approved investigational medicinal
- •product within 90 days before screeninga.
Investigators
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