A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy; Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: NNC 0148-0000-0362; Drug: insulin glargine; Drug: placebo

• Registration Number: NCT01597713
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect of drug) of NNC 0148-0000-0362 as tablets in healthy volunteers.

The trial consists of two parts. In part 1, single escalating doses of NNC 0148-0000-0362, placebo or insulin glargine is given. In part 2, subjects will receive single doses of NNC 0148-0000-0362 administered orally or intravenously.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-10
• Study First Submitted QC: 2012-05-10
• Study First Posted: 2012-05-14
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-28
• Last Update Posted: 2015-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 83

Inclusion Criteria

• Body mass index 18-28 kg/m^2 (both inclusive)
• 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1, level 1-7 escalating doses	NNC 0148-0000-0362	-
Part 2, cross-over	NNC 0148-0000-0362	-
Part 1, level 1-7 escalating doses	placebo	-
Part 1, level 1-7 escalating doses	insulin glargine	-

Primary Outcome Measures

Name	Time	Method
Number of adverse events	Recorded from trial product administration and until completion of Sub-visit G (i.e. Day 13) of the dosing visit

Secondary Outcome Measures

Name	Time	Method
Area under the glucose infusion rate (GIR)-time curve (Trial part 1)	From 0 to 24 hours after a single oral dose of NNC 0148-0000-0362 or a single s.c. dose of insulin glargine, respectively
Area under the serum insulin concentration-time curve (Trial part 2)	From 0 hours to infinity after a single dose of NNC 0148-0000-0362 administered orally as 1 and 3 tablets and intravenously, respectively
Area under the serum insulin concentration-time curve (with Trial part 1)	From 0 to 288 hours after a single oral dose of NNC 0148-0000-0362 or a single subcutaneous (s.c.) dose of insulin glargine, respectively