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Safety of NNC 0123-0000-0338 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01334034
Recruitment Status : Completed
First Posted : April 12, 2011
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body), and the pharmacodynamics (the effect of the investigated drug on the body) of NNC 0123-0000-0338 as tablets in healthy subjects.

Condition or disease Intervention/treatment Phase
Diabetes Healthy Drug: NNC 0123-0000-0338 Drug: placebo Drug: insulin glargine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 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 NNC 0123-0000-0338 in Healthy Subjects
Actual Study Start Date : April 11, 2011
Actual Primary Completion Date : September 16, 2011
Actual Study Completion Date : September 16, 2011

Arm Intervention/treatment
Experimental: Dose levels 1-7 Drug: NNC 0123-0000-0338
Subjects will be randomised to receive a single dose of NNC 0123-0000-0338 (tablet), at 7 escalating dose levels. Progression to next dose level will be based on a safety evaluation.
Drug: placebo
Subjects will receive a single dose of placebo (tablet), as a comparator to NNC 0123-0000-0338 at all dose levels. Placebo dose remains the same at all dose levels.
Drug: insulin glargine
As an open label active comparator, a single dose of insulin glargine will be administered subcutaneously (under the skin), at all dose levels. Insulin glargine dose remains the same at all dose levels.



Primary Outcome Measures :
  1. Number of adverse events [ Time Frame: from trial product administration and until completion of the dosing visit (Day 0 to Day 6) ]

Secondary Outcome Measures :
  1. Area under the serum insulin concentration-time curve [ Time Frame: from 0 to 120 hours after a single dose ]
  2. Area under the glucose infusion rate-time curve [ Time Frame: from 0 to 24 hours after a single dose ]


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:

  • Male subject
  • Body mass index (BMI) between 18 and 28 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial products or related products
  • Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the trial physician
  • Presence of any medical condition that may confound the results of the trial or pose an unacceptable risk to the subject by administering the trial product, as judged by the trial physician

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): NCT01334034


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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01334034     History of Changes
Other Study ID Numbers: NN1953-3832
U1111-1118-2525 ( Other Identifier: WHO )
2010-023885-38 ( EudraCT Number )
First Posted: April 12, 2011    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs