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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled Single Dose, Dose Escalation Trial With Insulin 454 in Healthy Male Subjects, Followed by a Two-period Cross-over Trial With Insulin 454 and Insulatard® in Male Subjects With Type 1 and Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01865279
• Other study ID #: NN5401-1718
• Secondary ID: 2005-003974-65
• Status: Completed
• Phase: Phase 1
• First received: May 27, 2013
• Last updated: October 22, 2015
• Start date: December 2005
• Est. completion date: April 2006

Study information

• Verified date: October 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

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
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin degludec
Ascending single doses - 5 dose levels. Escalation to next dose level will be performed following evaluation of safety data.
• placebo
Ascending single doses - 5 dose levels
• insulin degludec
A single dose corresponding to that of isophane human insulin
• isophane human insulin
A single dose of 0.4 IU/kg is administered to subjects with type 1 diabetes while a single dose of 0.6 IU/kg is administered to subjects with type 2 diabetes

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	Frequency of adverse events (trial part 1 only)		From day prior to dosing and until 10-14 days after dosing	No
Primary	Area under the glucose infusion rate curve (trial part 2 only)		0-24 hours after dosing	No
Secondary	Area under the serum insulin concentration curve		0-72 hours after dosing	No

External Links

•   Clinical Trials at Novo Nordisk