A Two Part Trial Investigating NN1952 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerance, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NN1952 as tablets in healthy volunteers and subjects with type 1 and type 2 diabetes. The trial consists of two parts. In part 1, single escalating doses of NN1952, placebo or insulin aspart will be given to healthy volunteers. In part 2, subjects with type 1 or type 2 diabetes will receive single doses of NN1952 (with/without a meal), insulin aspart and placebo.

Official Title
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A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 0148-0000-0106 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes

Conditions
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Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Healthy

Intervention / Treatment
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* Drug: NN1952
* Drug: insulin aspart
* Drug: placebo
* Drug: NN1952
* Drug: insulin aspart
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: FOR TRIAL PART 1, THE FOLLOWING APPLIES: Gender: male Age: 18-55 years BMI (body mass index): 18-28 kg/m2 Study participants considered to be healthy FOR TRIAL PART 2, THE FOLLOWING APPLIES: Gender: male or female of no childbearing potential Age: 18-65 years Type 1 diabetes: BMI (body mass index): 18-28 kg/m2 Type 2 diabetes: BMI (body mass index): 22-35 kg/m2 Type 1 or type 2 diabetes for at least 12 months Type 1 diabetes: Treatment with insulin for at least 12 months Type 2 diabetes: Treatment with insulin for at least 3 months Exclusion Criteria: Known or suspected allergy to the trial product or related products Presence of illness or infection that may confound the results of the study or pose a risk to the study participant by dosing NN1952, as judged by the Investigator Presence of acute gastrointestinal symptoms (for example nausea, vomiting, heartburn or diarrhoea)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Trial part 1<br> | Drug: NN1952<br>* Subjects will be randomised to receive a single dose of NN1952, at escalating dose levels. Progression to next dose will be based on safety evaluation.<br>Drug: insulin aspart<br>* As an active comparator, one standard dose will be given s.c. (under the skin) at all dose levels.<br>Drug: placebo<br>* Subjects will receive a single dose of placebo as a comparator to NN1952, at all dose levels.<br>|
| Experimental: Trial part 2<br> | Drug: NN1952<br>* Subjects will be randomised to receive a single dose of NN1952 with or without a meal, on two of four separate study visits. The dose will be selected based on the results of part 1.<br>Drug: insulin aspart<br>* As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit.<br>Drug: placebo<br>* Subjects will receive a single dose of placebo as a comparator to NN1952 at one study visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and severity of adverse events for trial part 1 |  | from visit 1 to visit 3 | 
| Number and severity of adverse events for trial part 2 |  | from visit 1 to visit 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin concentration-time curve after a single dose |  | after 12 hours | 
| Area under the glucose infusion rate-time curve after a single dose |  | after 12 hours |