Back to resultsA Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in Subjects With Type 2 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
insulin 338 (GIPET I)
placebo
insulin glargine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility 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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Insulin 338 + placebo
Insulin glargine + placebo
Arm Description
Outcomes
Primary Outcome Measures
Number of treatment emergent adverse events
Secondary Outcome Measures
Area under the serum insulin concentration-time curve
Area under the glucose infusion rate-time curve
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01796366
Brief Title
A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in Subjects With Type 2 Diabetes
Official Title
A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in Subjects With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 21, 2013 (Actual)
Primary Completion Date
August 19, 2013 (Actual)
Study Completion Date
August 19, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin 338 + placebo
Arm Type
Experimental
Arm Title
Insulin glargine + placebo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
insulin 338 (GIPET I)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
S.c placebo administered in combination with insulin 338
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Oral placebo administered in combination with s.c. insulin glargine
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Area under the serum insulin concentration-time curve
Time Frame
During one dosing interval (0-24 hours) at steady-state (Day 10)
Title
Area under the glucose infusion rate-time curve
Time Frame
During one dosing interval (0-24 hours) at steady state (Day 10)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Neuss
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in Subjects With Type 2 Diabetes
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