A Research Study of How Different Doses of a New Medicine NNC0148-0287 C (Insulin 287) Work on the Blood Sugar in People With Type 1 Diabetes When it is Taken Once a Week
NCT03723772 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2025-03-11
Summary
This study compares the new long-acting insulin 287 with the marketed insulin glargine for use in type 1 diabetes. The study will test how insulin is taken up in your blood, how long it stays there and how the blood sugar is lowered. The participant will get both of the insulins in a random order. Insulin 287 is a new medicine while insulin glargine is already approved for the treatment of diabetes and can be prescribed by a doctor. The participant will get 8 weekly doses of insulin 287 and 14 daily doses of insulin glargine. There will also be a run-in period of 2 days to 4 weeks with daily doses of insulin glargine before you start the insulin 287 period. All doses will be injected under the skin. The study will last for about 16 to 24 weeks. The participant will have 27 visits with the study doctor.
Conditions
- Diabetes Mellitus, Type 1
Interventions
- DRUG
-
Insulin icodec
Participants will receive subcutaneous injections of insulin 287 once weekly for 8 weeks
- DRUG
-
IGlar U100
Participants will receive subcutaneous injections of insulin glargine once weekly for 2 weeks.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Reporting Anchor and Disclosure (1452) · Novo Nordisk A/S
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-11-29
- Primary Completion
- 2020-06-26
- Completion
- 2020-06-26
Countries
- Germany
Study Locations
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