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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01597713
First received: May 10, 2012
Last updated: November 8, 2012
Last verified: November 2012

May 10, 2012
November 8, 2012
May 2012
October 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01597713 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy Subjects
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Healthy
  • 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 1, level 1-7 escalating doses
    Interventions:
    • Drug: NNC 0148-0000-0362
    • Drug: insulin glargine
    • Drug: placebo
  • Experimental: Part 2, cross-over
    Interventions:
    • Drug: NNC 0148-0000-0362
    • Drug: NNC 0148-0000-0362
    • Drug: NNC 0148-0000-0362
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01597713
NN1954-3936, 2011-005147-27, U1111-1125-2969
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Inge Birk Halberg Novo Nordisk A/S
Novo Nordisk A/S
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP