Back to resultsA Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy Subjects
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2, Healthy
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
NNC 0148-0000-0362
insulin glargine
placebo
NNC 0148-0000-0362
NNC 0148-0000-0362
NNC 0148-0000-0362
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Part 1, level 1-7 escalating doses
Part 2, cross-over
Arm Description
Outcomes
Primary Outcome Measures
Number of adverse events
Secondary Outcome Measures
Area under the serum insulin concentration-time curve (with Trial part 1)
Area under the glucose infusion rate (GIR)-time curve (Trial part 1)
Area under the serum insulin concentration-time curve (Trial part 2)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01597713
Brief Title
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy Subjects
Official Title
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2, Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1, level 1-7 escalating doses
Arm Type
Experimental
Arm Title
Part 2, cross-over
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NNC 0148-0000-0362
Intervention Description
Subjects will be randomised to receive a single dose of NNC 0148-0000-0362 orally within each dose group
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Description
As an active comparator, one standard dose will be given subcutaneously (s.c., under the skin) within each dose group
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Subjects will receive a single dose of oral placebo within each dose group
Intervention Type
Drug
Intervention Name(s)
NNC 0148-0000-0362
Intervention Description
Single low dose administered orally in randomised order on three dosing visits separated by a wash-out period
Intervention Type
Drug
Intervention Name(s)
NNC 0148-0000-0362
Intervention Description
Single high dose administered i.v. in randomised order on three dosing visits separated by a wash-out period
Intervention Type
Drug
Intervention Name(s)
NNC 0148-0000-0362
Intervention Description
Single high dose administered orally in randomised order on three dosing visits separated by a wash-out period
Primary Outcome Measure Information:
Title
Number of adverse events
Time Frame
Recorded from trial product administration and until completion of Sub-visit G (i.e. Day 13) of the dosing visit
Secondary Outcome Measure Information:
Title
Area under the serum insulin concentration-time curve (with Trial part 1)
Time Frame
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
Title
Area under the glucose infusion rate (GIR)-time curve (Trial part 1)
Time Frame
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
Title
Area under the serum insulin concentration-time curve (Trial part 2)
Time Frame
From 0 hours to infinity after a single dose of NNC 0148-0000-0362 administered orally as 1 and 3 tablets and intravenously, respectively
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
City
Neuss
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy Subjects
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