Comparison of Insulin Degludec With Insulin Glargine in Subjects With Type 1 Diabetes Mellitus

Diabetes Clinical Trial

Official title:

A Randomised, Single Centre, Double-blind, Two-Period Cross-over, Multiple Dose Trial Comparing the Pharmacodynamic Response of Insulin 454 With Insulin Glargine at Steady-State Conditions in Subjects With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868529
• Other study ID #: NN1250-1876
• Secondary ID: 2007-003534-41
• Status: Completed
• Phase: Phase 1
• First received: May 30, 2013
• Last updated: September 24, 2015
• Start date: January 2008
• Est. completion date: June 2008

Study information

• Verified date: September 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This trial was conducted in Europe. The aim of this trial was to compare the pharmacodynamic (the effect of the investigated drug on the body) response of insulin degludec (insulin 454) with insulin glargine at steady-state conditions in subjects with type 1 diabetes mellitus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes mellitus (as diagnosed clinically) and treated with insulin for at least 12 months

• Subject is considered to be generally healthy, except for the underlying diabetes mellitus and related morbidity (such as well controlled hypertension and dyslipidaemia) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator

• Body Mass Index (BMI) between 18.0 and 28.0 kg/m^2 (both inclusive)

• Glycosylated haemoglobin (HbA1c) below or equal to 10.0 % based on central laboratory results

• Subject with a daily basal insulin requirement of between 0.2 IU/kg/day and 0.6 IU/kg/day will be allowed to participate in the trial. Current total daily treatment with insulin must be less than 1.2 U/kg/day

Exclusion Criteria:

• Known or suspected allergy to trial product(s) or related products

• Subject who has participated in any other trials involving investigational products within 3 months preceding the start of dosing

• Subject who has donated any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin degludec
Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment.
• insulin glargine
Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the glucose infusion rate curve		0-24 hours in steady-state	No
Secondary	Area under the serum insulin concentration curve at steady state		0-24 hours after dosing	No

External Links

•   Clinical Trials at Novo Nordisk