Comparing the Pharmacodynamics and Pharmacokinetics of Explorative Formulation of Insulin Degludec With Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin degludec; Drug: insulin glargine

• Registration Number: NCT01865292
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics (the effect of the investigated drug on the body) and pharmacokinetics (the exposure of the trial drug in the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, with insulin glargine in subjects with type 1 and type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Study First Submitted: 2013-05-27
• Study First Submitted QC: 2013-05-27
• Study First Posted: 2013-05-30
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-16
• Last Update Posted: 2015-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Glycosylated haemoglobin (HbA1c) below or equal to 10 procent based on central laboratory results
• Specific inclusion criteria for subject with type 1 diabetes:
• Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months prior to screening
• Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
• Specific inclusion criteria for subject with type 2 diabetes:
• Diagnosed with type 2 diabetes mellitus for at least 12 months prior to screening
• Treated with insulin for the past 3 months prior to screening
• Body Mass Index (BMI) between 22.0 and 35.0 kg/ m^2 (both inclusive)

Exclusion Criteria

• Subject with a history of significant multiple drug allergies or with a known allergy or suspected allergy to the trial product or any medicine chemically related to the trial product,as judged by the Investigator.
• Subject with a history of or presence of cancer
• Any condition that the Investigator and/or Sponsor feels would interfere with study
• Specific exclusion criteria for subject with type 2 diabetes:
• Therapy with oral antidiabetic drugs within the past 3 months prior to screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Insulin degludec	insulin degludec	-
Insulin glargine	insulin glargine	-

Primary Outcome Measures

Name	Time	Method
Area under the glucose infusion rate curve	0-24 hours after dosing

Secondary Outcome Measures

Name	Time	Method
Area under the insulin degludec/insulin glargine curve	0-96 hours after dosing