Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Explorative Formulation of Insulin Degludec

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin degludec; Drug: placebo; Drug: isophane human insulin

• Registration Number: NCT01865279
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commerical formulation.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2006-04
• Study Completion: 2006-04
• 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: 2015-10-22
• Last Update Posted: 2015-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

Inclusion Criteria

• HEALTHY SUBJECTS:
• Subjects will be healthy male subjects, who are considered to be generally healthy based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
• Body mass index (BMI) between 18.0-27.0 kg/m^2 (both inclusive)
• SUBJECTS WITH TYPE 1 AND TYPE 2 DIABETES:
• Subjects will be male volunteers, who are considered to be generally healthy, except for the underlying diabetes mellitus, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
• Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months or diagnosed with type 2 diabetes mellitus for at least 12 months
• Body Mass Index (BMI) between 18.0-27.0 kg/m^2 (both inclusive) for subjects with type 1 diabetes or 25.0-35.0 kg/m^2 (both inclusive) for subjects with type 2 diabetes
• Glycogylated haemoglobin (HbA1c) maximum 8.5 % based on central laboratory results
• Subjects with type 2 diabetes must have been treated with insulin for the past 3 months prior to screening

Exclusion Criteria

• Participation in any other trials involving investigational products within 3 months preceding the start of dosing
• History of significant multiple drug allergies or with a known allergy to the trial product or any medicine chemically related to the trial product, as judged by the investigator
• Hepatitis or carrier of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies or a positive result to the test for human immunodeficiency (HIV) antibodies
• Any clinically significant abnormal haematology or biochemistry screening tests, as judged by the investigator
• Subjects who have donated any blood or plasma in the past month or in excess of 1000 ml within the 12 weeks preceding screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Trial part 1	placebo	-
Trial part 2	isophane human insulin	-
Trial part 2	insulin degludec	-
Trial part 1	insulin degludec	-

Primary Outcome Measures

Name	Time	Method
Frequency of adverse events (trial part 1 only)	From day prior to dosing and until 10-14 days after dosing
Area under the glucose infusion rate curve (trial part 2 only)	0-24 hours after dosing

Secondary Outcome Measures

Name	Time	Method
Area under the serum insulin concentration curve	0-72 hours after dosing