A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered NNC0148-0287 (Insulin 287) in Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of subcutaneously administered NNC0148-0287 (insulin 287) in subjects with type 2 diabetes

Official Title
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A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered NNC0148-0287 (Insulin 287) in Subjects With Type 2 Diabetes

Conditions
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Diabetes, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Insulin icodec
* Drug: insulin degludec
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age between 18 and 64 years (both inclusive) at the time of signing informed consent Females of no childbearing potential [if surgically sterilized (i.e. tubal ligation, bilateral oophorectomises or hysterectomised) for at least 3 months or if post-menopausal (i.e. as defined by amenorrhoea for at least 12 months prior to screening and documented by FSH (follicle-stimulating hormone) levels above 40 U/L] Body mass index (BMI) between 20.0 and 35.0 kg/m^2 (both inclusive) Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months Exclusion Criteria: Known or suspected hypersensitivity to trial products or related products Receipt of any investigational medicinal products within 3 months before screening Use of oral antidiabetic drugs (OADs) or glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide) 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin 287 + placebo<br>Subjects will receive one of two treatment combinations: either insulin 287 + placebo or insulin degludec + placebo. Dose escalation design (4 dose levels). | Drug: Insulin icodec<br>* Administered once-weekly subcutaneously (s.c., under the skin) for 35 days<br>* Other names: insulin 287;Drug: placebo<br>* Administered subcutaneously (s.c., under the skin) once-daily for 35 days<br>|
| Active Comparator: Insulin degludec + placebo<br>Subjects will receive one of two treatment combinations: either insulin 287 + placebo or insulin degludec + placebo. Dose escalation design (4 dose levels). | Drug: insulin degludec<br>* Administered once-daily subcutaneously (s.c., under the skin) for 35 days<br>Drug: placebo<br>* Administered subcutaneously (s.c., under the skin) once-daily for 35 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 |  | From the first trial product administration at Day 1 until completion of the post-treatment follow-up visit (3-14 days after Visit 9, Day 65) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the steady-state serum insulin 287 concentration-time curve |  | During one dosing interval at steady-state from 0 to 168 h after last dose (Day 29) | 
| area under the glucose infusion rate - time curve at steady-state |  | At Day 31 and day 35 |