A Research Study to See How Switching from a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults with Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Registration Number
- 2023-506084-34-00
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
To demonstrate the effect on glycaemic control of once-weekly insulin icodec, switched unit-to-unit from a daily basal insulin, with or without non-insulin anti-diabetic drugs, in participants with T2D treated with basal insulin. This includes comparing the difference in change from baseline in HbA1c between insulin icodec and insulin glargine U100 after 26 weeks of treatment to a non-inferiority margin of 0.3%-point.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ended
- Sex
- Not specified
- Target Recruitment
- 145
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 or twice-daily basal insulin (Neutral Protamine Hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 U/mL, or insulin glargine 300 U/mL) ≥ 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, Injectable GLP-1/GIP RA combination products
Body mass index (BMI) ≤ 40.0 kg/m2.
Any episodes 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
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HbA1c from baseline week 0 (V6) to week 26 (V32) Change in HbA1c from baseline week 0 (V6) to week 26 (V32)
- Secondary Outcome Measures
Name Time Method Change in time in range 3.9–10.0 mmol/L (70–180 mg/dL) Change in time in range 3.9–10.0 mmol/L (70–180 mg/dL)
Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire status version) total treatment satisfaction Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire status version) total treatment satisfaction
Number of severe hypoglycaemic episodes (level 3) (safety) Number of severe hypoglycaemic episodes (level 3) (safety)
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) (safety) Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) (safety)
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
Time spent < 3.0 mmol/L (54 mg/dL) Time spent < 3.0 mmol/L (54 mg/dL)
Change in time spent > 10.0 mmol/L (180 mg/dL) Change in time spent > 10.0 mmol/L (180 mg/dL)
Mean weekly insulin dose Mean weekly insulin dose
Change in body weight Change in body weight
Trial Locations
- Locations (23)
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
🇵🇱Warsaw, Poland
Niepubliczny Zakład Opieki Zdrowotnej Vita-Diabetica Małgorzata Buraczyk
🇵🇱Białystok, Poland
Pratia S.A.
🇵🇱Katowice, Poland
Trialmed Sp. z o.o.
🇵🇱Piotrkow Trybunalski, Poland
Uniwersytecki Szpital Kliniczny W Opolu
🇵🇱Opole, Poland
Niepublicznego Zakladu Opieki Zdrowotnej Specjalistyczny Osrodek Internistyczno Diabetologiczny
🇵🇱Bialystok, Poland
Zentrum für klinische Forschung Allgäu Oberschwaben
🇩🇪Wangen, Germany
Schwerpunktpraxis für Diabetes und Ernährungsmedizin
🇩🇪Münster, Germany
InnoDiab Forschung GmbH
🇩🇪Essen, Germany
Institut für Diabetesforschung Osnabrück
🇩🇪Osnabrück, Germany
Scroll for more (13 remaining)Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji🇵🇱Warsaw, PolandEdward FranekSite contact+48225081405edward.franek@cskmswia.gov.pl