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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01796366
• Other study ID #: NN1953-4013
• Secondary ID: 2012-003046-32U1
• Status: Completed
• Phase: Phase 1
• First received: February 20, 2013
• Last updated: February 28, 2017
• Start date: February 21, 2013
• Est. completion date: August 19, 2013

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 19, 2013
• Est. primary completion date: August 19, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.
• placebo
S.c placebo administered in combination with insulin 338
• 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.
• placebo
Oral placebo administered in combination with s.c. insulin glargine

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment emergent adverse events		As recorded from first trial product administration (Day 1) and until Sub-visit 2A (Day 12) of the dosing visit
Secondary	Area under the serum insulin concentration-time curve		During one dosing interval (0-24 hours) at steady-state (Day 10)
Secondary	Area under the glucose infusion rate-time curve		During one dosing interval (0-24 hours) at steady state (Day 10)

External Links

•   Clinical Trials at Novo Nordisk