Back to resultsA Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy Subjects
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
insulin 287
insulin glargine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Body mass index 18.0-28.0 kg/m^2
- Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator
Exclusion Criteria:
- Known or suspected hypersensitivity to trial products or related products
- Previous participation in this trial. Participation is defined as randomised
- 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 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Dose level 1
Dose level 2
Dose level 3
Dose level 4
Dose level 5
Dose level 6
Dose level 7
Arm Description
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Outcomes
Primary Outcome Measures
Number of adverse events (AEs)
Secondary Outcome Measures
Area under the serum insulin concentration-time curve
Area under the glucose infusion rate (GIR)-time curve
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01809184
Brief Title
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy Subjects
Official Title
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 4, 2013 (Actual)
Primary Completion Date
September 6, 2013 (Actual)
Study Completion Date
September 6, 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 this first human dose trial is to investigate the safety, tolerability, pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (exposure of the trial drug in the body) properties of NNC0148-0000-0287 (insulin 287) in a GIPET® I tablet formulation in healthy subjects.
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
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose level 1
Arm Type
Experimental
Arm Description
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Arm Title
Dose level 2
Arm Type
Experimental
Arm Description
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Arm Title
Dose level 3
Arm Type
Experimental
Arm Description
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Arm Title
Dose level 4
Arm Type
Experimental
Arm Description
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Arm Title
Dose level 5
Arm Type
Experimental
Arm Description
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Arm Title
Dose level 6
Arm Type
Experimental
Arm Description
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Arm Title
Dose level 7
Arm Type
Experimental
Arm Description
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Intervention Type
Drug
Intervention Name(s)
insulin 287
Intervention Description
Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Description
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Oral placebo adminstered corresponding to insulin 287 treatment
Primary Outcome Measure Information:
Title
Number of adverse events (AEs)
Time Frame
As recorded from trial product administration and until completion of Sub-visit 2G (Day 13)
Secondary Outcome Measure Information:
Title
Area under the serum insulin concentration-time curve
Time Frame
From 0 to 648 hours after a single dose
Title
Area under the glucose infusion rate (GIR)-time curve
Time Frame
From 0 to 24 hours after a single dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Body mass index 18.0-28.0 kg/m^2
Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator
Exclusion Criteria:
Known or suspected hypersensitivity to trial products or related products
Previous participation in this trial. Participation is defined as randomised
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 Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy Subjects
We'll reach out to this number within 24 hrs