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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
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Healthy
Drug: NNC 0148-0000-0362
Drug: insulin glargine
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 83
Study Start Date: May 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: Part 2, cross-over 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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597713

Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Inge Birk Halberg Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01597713     History of Changes
Other Study ID Numbers: NN1954-3936, 2011-005147-27, U1111-1125-2969
Study First Received: May 10, 2012
Last Updated: November 8, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014