A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01796366
First received: February 20, 2013
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0123-0000-0338 (insulin 338) in subjects with type 2 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin 338 (GIPET I)
Drug: placebo
Drug: insulin glargine
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 Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in Subjects With Type 2 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of treatment emergent adverse events [ Time Frame: As recorded from first trial product administration (Day 1) and until Sub-visit 2A (Day 12) of the dosing visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the serum insulin concentration-time curve [ Time Frame: During one dosing interval (0-24 hours) at steady-state (Day 10) ] [ Designated as safety issue: No ]
  • Area under the glucose infusion rate-time curve [ Time Frame: During one dosing interval (0-24 hours) at steady state (Day 10) ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin 338 + placebo Drug: insulin 338 (GIPET I)
Each subject will be allocated to one of three dosing periods only. The subject will receive oral insulin 338 and placebo, administered subcutaneously (s.c., under the skin) once daily for 10 days at fixed dose levels.
Drug: placebo
S.c placebo administered in combination with insulin 338
Active Comparator: Insulin glargine + placebo Drug: insulin glargine
Each subject will be allocated to one of three dosing periods only. The subject will receive insulin glargine for s.c. administration and oral placebo once daily for 10 days at fixed dose levels.
Drug: placebo
Oral placebo administered in combination with s.c. insulin glargine

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male subject, or female subject of no childbearing potential, if surgically sterilized (i.e. tubal ligation, bilateral oopherectomies (removal of both ovaries and both fallopian tubes) or hysterectomised) for at least 3 months or if postmenopausal (i.e. as defined by amenorrhoea for at least 12 months prior to screening and documented by follicle stimulating hormone (FSH) levels above 40 U/L)
  • Body mass index (BMI) between 20.0 and 35.0 kg/m^2 (both inclusive)
  • Type 2 diabetes mellitus (as diagnosed clinically) for 12 months or more

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 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: NCT01796366

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: NCT01796366     History of Changes
Other Study ID Numbers: NN1953-4013, 2012-003046-32, U1111-1132-0943
Study First Received: February 20, 2013
Last Updated: August 20, 2013
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
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014