- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02536859
Comparing Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec and Insulin Glargine 300 U/mL at Steady-state Conditions in Subjects With Type 1 Diabetes Mellitus
April 30, 2019 updated by: Novo Nordisk A/S
A Randomised, Single-centre, Double-blind, Two-period Cross-over, Multiple Dose Trial Comparing Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec and Insulin Glargine 300 U/mL at Steady-state Conditions in Subjects With Type 1 Diabetes Mellitus
This trial is conducted in Europe.
The aim of this trial is to compare pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (the exposure of the trial drug in the body) properties of insulin degludec and insulin glargine 300 U/mL at steady-state conditions in subjects with type 1 diabetes mellitus.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Neuss, Germany, 41460
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female aged 18-64 years (both inclusive) at the time of signing informed consent
- Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening
- Body mass index 18.5-29.0 kg/m^2 (both inclusive)
Exclusion Criteria:
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the in-patient period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: IDeg
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Dose levels will be 0.4 U/kg body weight.
The trial products will be administered subcutaneously (s.c., under the skin) once daily.
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Active Comparator: IGlar U300
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Dose levels will be 0.4 U/kg body weight.
The trial products will be administered subcutaneously (s.c., under the skin) once daily.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the glucose infusion rate curve
Time Frame: During one dosing interval (0-24h) at steady-state. At day 6, 9 and 12
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During one dosing interval (0-24h) at steady-state. At day 6, 9 and 12
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the glucose infusion rate curve
Time Frame: During one dosing interval at steady state.At day 6, 9 and 12
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During one dosing interval at steady state.At day 6, 9 and 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Heise T, Kaplan K, Haahr HL. Day-to-Day and Within-Day Variability in Glucose-Lowering Effect Between Insulin Degludec and Insulin Glargine (100 U/mL and 300 U/mL): A Comparison Across Studies. J Diabetes Sci Technol. 2018 Mar;12(2):356-363. doi: 10.1177/1932296817731422. Epub 2017 Sep 26.
- Heise T, Norskov M, Nosek L, Kaplan K, Famulla S, Haahr HL. Insulin degludec: Lower day-to-day and within-day variability in pharmacodynamic response compared with insulin glargine 300 U/mL in type 1 diabetes. Diabetes Obes Metab. 2017 Jul;19(7):1032-1039. doi: 10.1111/dom.12938. Epub 2017 Apr 23.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 31, 2015
Primary Completion (Actual)
April 14, 2016
Study Completion (Actual)
April 14, 2016
Study Registration Dates
First Submitted
August 28, 2015
First Submitted That Met QC Criteria
August 28, 2015
First Posted (Estimate)
September 1, 2015
Study Record Updates
Last Update Posted (Actual)
May 1, 2019
Last Update Submitted That Met QC Criteria
April 30, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN1250-4227
- 2014-005602-37 (EudraCT Number)
- U1111-1165-3940 (Other Identifier: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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