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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

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ClinicalTrials.gov Identifier: NCT02536859
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: insulin degludec Drug: insulin glargine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 31, 2015
Actual Primary Completion Date : April 14, 2016
Actual Study Completion Date : April 14, 2016


Arm Intervention/treatment
Experimental: IDeg Drug: insulin degludec
Dose levels will be 0.4 U/kg body weight. The trial products will be administered subcutaneously (s.c., under the skin) once daily.

Active Comparator: IGlar U300 Drug: insulin glargine
Dose levels will be 0.4 U/kg body weight. The trial products will be administered subcutaneously (s.c., under the skin) once daily.




Primary Outcome Measures :
  1. Area under the glucose infusion rate curve [ Time Frame: During one dosing interval (0-24h) at steady-state. At day 6, 9 and 12 ]

Secondary Outcome Measures :
  1. Area under the glucose infusion rate curve [ Time Frame: During one dosing interval at steady state.At day 6, 9 and 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536859


Locations
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Germany
Novo Nordisk Investigational Site
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02536859    
Other Study ID Numbers: NN1250-4227
2014-005602-37 ( EudraCT Number )
U1111-1165-3940 ( Other Identifier: WHO )
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs