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Compares treatment options for Diabetes Mellitus, Type 1
Official title 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
ClinicalTrials.gov ID: NCT07076199
What this study is testing
What is Insulin icodec?
Insulin icodec is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for diabetes mellitus, type 1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- Any condition, except for conditions associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's...
- Anticipated initiation or anticipated change in concomitant medications (for more than 15 consecutive days) known to affect weight or glucose...
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cullman, Alabama, United States
- Concord, California, United States
- Escondido, California, United States
- Fresno, California, United States
- Fullerton, California, United States
- La Jolla, California, United States
- Loma Linda, California, United States
- Los Alamitos, California, United States
- Los Angeles, California, United States
- Pasadena, California, United States
- Pomona, California, United States
- San Diego, California, United States
- San Mateo, California, United States
- Santa Clarita, California, United States
- Tustin, California, United States
- Walnut Creek, California, United States
- Englewood, Colorado, United States
- Golden, Colorado, United States
- Fleming Island, Florida, United States
- Hollywood, Florida, United States
+ 134 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cullman, Alabama, United States; Concord, California, United States; Escondido, California, United States; Fresno, California, United States; Fullerton, California, United States; La Jolla, California, United States and 148 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.