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Safety of NNC 0123-0000-0338 in Healthy Subjects

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: April 11, 2011
Last updated: February 28, 2017
Last verified: February 2017
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 Intervention Phase
Drug: NNC 0123-0000-0338
Drug: placebo
Drug: insulin glargine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 0123-0000-0338 in Healthy Subjects

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

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

Enrollment: 70
Actual Study Start Date: April 11, 2011
Study Completion Date: September 16, 2011
Primary Completion Date: September 16, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
  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 identifier: NCT01334034

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

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01334034     History of Changes
Other Study ID Numbers: NN1953-3832
U1111-1118-2525 ( Other Identifier: WHO )
2010-023885-38 ( EudraCT Number )
Study First Received: April 11, 2011
Last Updated: February 28, 2017

Additional relevant MeSH terms:
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on April 28, 2017