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

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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

Study Description
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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.


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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy Subjects
Study Start Date : May 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012
Arms and Interventions
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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
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597713


Locations
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Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01597713    
Other Study ID Numbers: NN1954-3936
2011-005147-27 ( EudraCT Number )
U1111-1125-2969 ( Other Identifier: WHO )
First Posted: May 14, 2012    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs