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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Diabetes Mellitus, Type 2; Diabetes
• Intervention / Treatment: Drug: NNC 0148-0000-0362; Drug: insulin glargine; Drug: placebo; Drug: NNC 0148-0000-0362; Drug: NNC 0148-0000-0362; Drug: NNC 0148-0000-0362

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, 41460

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Part 1, level 1-7 escalating doses	Drug: NNC 0148-0000-0362; Subjects will be randomised to receive a single dose of NNC 0148-0000-0362 orally within each dose group; Drug: insulin glargine; As an active comparator, one standard dose will be given subcutaneously (s.c., under the skin) within each dose group; Drug: placebo; Subjects will receive a single dose of oral placebo within each dose group; Drug: NNC 0148-0000-0362; Single low dose administered orally in randomised order on three dosing visits separated by a wash-out period; Drug: NNC 0148-0000-0362; Single high dose administered i.v. in randomised order on three dosing visits separated by a wash-out period; Drug: NNC 0148-0000-0362; Single high dose administered orally in randomised order on three dosing visits separated by a wash-out period
EXPERIMENTAL: Part 2, cross-over	Drug: NNC 0148-0000-0362; Subjects will be randomised to receive a single dose of NNC 0148-0000-0362 orally within each dose group; Drug: NNC 0148-0000-0362; Single low dose administered orally in randomised order on three dosing visits separated by a wash-out period; Drug: NNC 0148-0000-0362; Single high dose administered i.v. in randomised order on three dosing visits separated by a wash-out period; Drug: NNC 0148-0000-0362; Single high dose administered orally in randomised order on three dosing visits separated by a wash-out period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: May 10, 2012
• First Submitted That Met QC Criteria: May 10, 2012
• First Posted (ESTIMATE): May 14, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 29, 2015
• Last Update Submitted That Met QC Criteria: May 28, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Glargine
• Other Study ID Numbers: NN1954-3936; 2011-005147-27 (EUDRACT_NUMBER); U1111-1125-2969 (OTHER: WHO)