Recruiting NCT07076199

A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes

Phase III Interventional Diabetes Mellitus, Type 1

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Insulin icodec, Insulin glargine, Insulin aspart.
Who it may be relevant to: Registry conditions: Diabetes Mellitus, Type 1. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Canada, Germany, Poland +3
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A 26-week Study Comparing the Efficacy and Safety of Once-weekly Insulin Icodec and Once-daily Insulin Glargine U100, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes

Overview

This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. The study will last for about 8.5 months.

Interventions

Drug Insulin icodec
Insulin icodec will be administered as subcutaneous injection
Drug Insulin glargine
Insulin glargine will be administered as subcutaneous injection.
Drug Insulin aspart
Insulin aspart will be administered as a subcutaneous injection.

Primary outcome measures

Change in glycosylated haemoglobin (HbA1c) [Time frame: From baseline (week 0) to week 26]

Secondary outcome measures (9)

Change in time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL)) [Time frame: From baseline (week-2-0) to week 22-26]
Time spent less than (<)3.0 mmol/L (54 mg/dL) [Time frame: From week 22 to week 26]
Change in time spent greater than (>)10.0 mmol/L (180 mg/dL) [Time frame: From baseline (week-2-0) to week 22-26]
Number of severe hypoglycaemic episodes (level 3) [Time frame: From baseline (week 0) to week 31]
Number of clinically significant hypoglycaemicepisodes (level 2) (<3.0mmol/L [54 mg/dL],confirmed by blood glucose (BG) meter) [Time frame: From baseline (week 0) to week 31]
Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL], severe hypoglycaemic confirmed by BG meter) or episodes (level 3) [Time frame: From baseline (week 0) to week 31]
Number of continuous glucose continuous glucose (CGM)-based clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL]) [Time frame: From baseline (week 0) to week 31]
Mean total weekly insulin dose [Time frame: From week 24 to week 26]
Change in body weight [Time frame: From baseline (week 0) to week 26]

Eligibility criteria

Inclusion criteria

Diagnosed with type 1 diabetes mellitus greater than or equal to (≥) 1 year before screening.
Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before screening.
HbA1c from 7.0-10.0 percentage (%) (53.0-85.8 millimoles per mole (mmol/mol)), both inclusive, at screening confirmed by central laboratory analysis.
Ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles, based on the investigator's judgement.

Exclusion criteria

Known or suspected hypersensitivity to study intervention(s) or related products.
Previous participation in this study. Participation is defined as signed informed consent.
Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
Any condition, except for conditions associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Anticipated initiation or anticipated change in concomitant medications (for more than 15 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with thyroid hormones, or systemic corticosteroids).
Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's questionnaire question.
Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment