Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01597713
Recruitment Status : Completed
First Posted : May 14, 2012
Last Update Posted : May 29, 2015
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE May 10, 2012
First Posted Date  ICMJE May 14, 2012
Last Update Posted Date May 29, 2015
Study Start Date  ICMJE May 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2012)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2012)
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy Subjects
Official Title  ICMJE A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy Subjects
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2012)
83
Original Estimated Enrollment  ICMJE
 (submitted: May 10, 2012)
102
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01597713
Other Study ID Numbers  ICMJE NN1954-3936
2011-005147-27 ( EudraCT Number )
U1111-1125-2969 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Novo Nordisk A/S
Original Responsible Party Public Access to Clinical Trials, Novo Nordisk A/S
Current Study Sponsor  ICMJE Novo Nordisk A/S
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date May 2015

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