A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy Subjects

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of this first human dose trial is to investigate the safety, tolerability, pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (exposure of the trial drug in the body) properties of NNC0148-0000-0287 (insulin 287) in a GIPET® I tablet formulation in healthy subjects.

Official Title
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A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy Subjects

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: insulin 287
* Drug: insulin glargine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index 18.0-28.0 kg/m^2 Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator Exclusion Criteria: Known or suspected hypersensitivity to trial products or related products Previous participation in this trial. Participation is defined as randomised Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the investigator Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol

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

Sexes Eligible for Study
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Male

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: Dose level 1<br>Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group. | Drug: insulin 287<br>* Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.<br>Drug: insulin glargine<br>* Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.<br>Drug: placebo<br>* Oral placebo adminstered corresponding to insulin 287 treatment<br>|
| Experimental: Dose level 2<br>Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group. | Drug: insulin 287<br>* Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.<br>Drug: insulin glargine<br>* Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.<br>Drug: placebo<br>* Oral placebo adminstered corresponding to insulin 287 treatment<br>|
| Experimental: Dose level 3<br>Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group. | Drug: insulin 287<br>* Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.<br>Drug: insulin glargine<br>* Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.<br>Drug: placebo<br>* Oral placebo adminstered corresponding to insulin 287 treatment<br>|
| Experimental: Dose level 4<br>Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group. | Drug: insulin 287<br>* Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.<br>Drug: insulin glargine<br>* Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.<br>Drug: placebo<br>* Oral placebo adminstered corresponding to insulin 287 treatment<br>|
| Experimental: Dose level 5<br>Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group. | Drug: insulin 287<br>* Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.<br>Drug: insulin glargine<br>* Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.<br>Drug: placebo<br>* Oral placebo adminstered corresponding to insulin 287 treatment<br>|
| Experimental: Dose level 6<br>Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group. | Drug: insulin 287<br>* Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.<br>Drug: insulin glargine<br>* Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.<br>Drug: placebo<br>* Oral placebo adminstered corresponding to insulin 287 treatment<br>|
| Experimental: Dose level 7<br>Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group. | Drug: insulin 287<br>* Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.<br>Drug: insulin glargine<br>* Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.<br>Drug: placebo<br>* Oral placebo adminstered corresponding to insulin 287 treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events (AEs) |  | As recorded from trial product administration and until completion of Sub-visit 2G (Day 13) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin concentration-time curve |  | From 0 to 648 hours after a single dose | 
| Area under the glucose infusion rate (GIR)-time curve |  | From 0 to 24 hours after a single dose |