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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT01809184

Collaborator

(none)

Enrollment

Location

Arms

6.1

Actual Duration (Months)

13.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 2	Drug: insulin 287 Drug: insulin glargine Drug: placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 4, 2013

Actual Primary Completion Date :

Sep 6, 2013

Actual Study Completion Date :

Sep 6, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose level 1 Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.	Drug: insulin 287 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. Drug: insulin glargine Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels. Drug: placebo Oral placebo adminstered corresponding to insulin 287 treatment
Experimental: Dose level 2 Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.	Drug: insulin 287 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. Drug: insulin glargine Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels. Drug: placebo Oral placebo adminstered corresponding to insulin 287 treatment
Experimental: Dose level 3 Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.	Drug: insulin 287 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. Drug: insulin glargine Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels. Drug: placebo Oral placebo adminstered corresponding to insulin 287 treatment
Experimental: Dose level 4 Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.	Drug: insulin 287 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. Drug: insulin glargine Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels. Drug: placebo Oral placebo adminstered corresponding to insulin 287 treatment
Experimental: Dose level 5 Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.	Drug: insulin 287 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. Drug: insulin glargine Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels. Drug: placebo Oral placebo adminstered corresponding to insulin 287 treatment
Experimental: Dose level 6 Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.	Drug: insulin 287 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. Drug: insulin glargine Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels. Drug: placebo Oral placebo adminstered corresponding to insulin 287 treatment
Experimental: Dose level 7 Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.	Drug: insulin 287 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. Drug: insulin glargine Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels. Drug: placebo Oral placebo adminstered corresponding to insulin 287 treatment

Outcome Measures

Primary Outcome Measures

Number of adverse events (AEs) [As recorded from trial product administration and until completion of Sub-visit 2G (Day 13)]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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