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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin 338 (GIPET I); Drug: insulin glargine; Drug: placebo

• Registration Number: NCT01796366
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-20
• Study First Submitted QC: 2013-02-20
• Study Start: 2013-02-21
• Study First Posted: 2013-02-21
• Primary Completion: 2013-08-19
• Study Completion: 2013-08-19
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin glargine + placebo	placebo	-
Insulin 338 + placebo	insulin 338 (GIPET I)	-
Insulin 338 + placebo	placebo	-
Insulin glargine + placebo	insulin glargine	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany