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

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

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

Germany

Novo Nordisk Investigational Site

Neuss, Germany, 41460

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452); Novo Nordisk A/S

More Information

Additional Information:

Clinical Trials at Novo Nordisk 

Publications of Results:

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.

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.

• 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
• Last Update Posted: May 1, 2019
• Last Verified: April 2019

Additional relevant MeSH terms:

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