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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

February 20, 2013
August 20, 2013
February 2013
August 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01796366 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in Subjects With Type 2 Diabetes
A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in Subjects With Type 2 Diabetes

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • 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
  • 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
  • Experimental: Insulin 338 + placebo
    Interventions:
    • Drug: insulin 338 (GIPET I)
    • Drug: placebo
  • Active Comparator: Insulin glargine + placebo
    Interventions:
    • Drug: insulin glargine
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01796366
NN1953-4013, 2012-003046-32, U1111-1132-0943
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Inge Birk Halberg Novo Nordisk A/S
Novo Nordisk A/S
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP