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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin 287; Drug: insulin glargine; Drug: placebo

• Registration Number: NCT01809184
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-04
• Study First Submitted: 2013-03-08
• Study First Submitted QC: 2013-03-08
• Study First Posted: 2013-03-12
• Primary Completion: 2013-09-06
• Study Completion: 2013-09-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose level 1	insulin glargine	Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 1	insulin 287	Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 1	placebo	Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 2	insulin glargine	Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 2	placebo	Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 3	insulin 287	Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 6	insulin 287	Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 6	insulin glargine	Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 3	placebo	Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 4	placebo	Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 5	insulin glargine	Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 5	placebo	Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 6	placebo	Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 7	placebo	Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 5	insulin 287	Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 2	insulin 287	Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 4	insulin 287	Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 3	insulin glargine	Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 4	insulin glargine	Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 7	insulin glargine	Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 7	insulin 287	Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany