A Study to Look at How Safe NNC0268-0965 is in People With Type 2 Diabetes

Study Overview
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Brief Summary
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This study looks at the safety and tolerability of the new medicine NNC0268-0965 (referred to as insulin 965), its concentration in the blood and its effect on the blood sugar for the treatment of diabetes. The study will test how insulin 965 is tolerated by the body, how it is taken up in the blood, how long it stays there and how the blood sugar is lowered. Participants will either get the new insulin 965 or the already marketed insulin glargine U100 (Lantus®) - which treatment is decided by chance. Participants will get six injections (one per day) of either insulin 965 or insulin glargine U100 under the skin of the left thigh. The study will last for about 5 weeks. Participants will have 6 clinic visits with the study doctor. Participants can only be in the study if the study doctor thinks that there are no risks for their health. Women can only take part in the study if they can't have children.

Official Title
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A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0268-0965 in Subjects With Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: NNC0268-0965
* Drug: insulin glargine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent. Diagnosed with type 2 diabetes mellitus 180 days or more prior to the day of screening. Male subject or female subject of non-child bearing potential. Non-child bearing potential being surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (as defined as no menses for 12 months without an alternative medical cause) prior to the day of screening. Current total daily insulin treatment between 0.25 (I)U/kg/day and 1.2 (I)U/kg/day (both inclusive). HbA1c equal to or below 9.5% Exclusion Criteria: Male of reproductive age who, or whose partner(s), is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice). Adequate contraceptive measures include that the male subject uses a condom during intercourse and that the partner practices adequate contraception (risk of pregnancy must be lower than 1%). Use of GLP-1 receptor agonists (e.g. exenatide, liraglutide, semaglutide) within 3 months prior to screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 cohorts are planned. Each cohort will consist of 12 subjects, with 9 subjects being randomised to receive NNC0268-0965 and 3 subjects being randomised to insulin glargine.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC0268-0965<br>Participants will receive NNC0268-0965 | Drug: NNC0268-0965<br>* One daily dose of 1.5, 4.0 or 6.0 nmol/kg administered s.c. (subcutaneously, under the skin) for 6 days<br>|
| Active Comparator: Insulin glargine<br>Participants will receive insulin glargine | Drug: insulin glargine<br>* One daily dose of 3.0 nmol/kg administered s.c. for 6 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment-emergent adverse events (AEs) | Number of events | From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit at day 12 (visit 5) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment-emergent hypoglycaemic episodes | Number of episodes | From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit at day 12 (visit 5) | 
| Area under the serum NNC0268-0965 concentration-time curve during one dosing interval at steady state | pmol*h/l | From 0 to 24 hours after IMP administration at day 6 (visit 2) | 
| Maximum observed serum NNC0268-0965 concentration after the last dose | pmol/l | From 0 to 24 hours after IMP administration at day 6 (visit 2) |