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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT01796366

Collaborator

(none)

Enrollment

Location

Arms

5.9

Actual Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 2	Drug: insulin 338 (GIPET I) Drug: placebo Drug: insulin glargine Drug: placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Actual Study Start Date :

Feb 21, 2013

Actual Primary Completion Date :

Aug 19, 2013

Actual Study Completion Date :

Aug 19, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Area under the serum insulin concentration-time curve [During one dosing interval (0-24 hours) at steady-state (Day 10)]
Area under the glucose infusion rate-time curve [During one dosing interval (0-24 hours) at steady state (Day 10)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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