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

NCT ID: NCT01865292

Last Updated: 2015-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2006-11-30

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.

Conditions

Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Insulin degludec

Group Type: EXPERIMENTAL

insulin degludec

Intervention Type: DRUG

Three single doses administrated subcutaneously (s.c., under the skin) on three separate dosing visits. Dose will vary when administered to subjects with type 1 and type 2 diabetes, respectively.

Insulin glargine

Group Type: ACTIVE_COMPARATOR

insulin glargine

Intervention Type: DRUG

Three single doses administrated subcutaneously (s.c., under the skin) on three separate dosing visits. Dose will vary when administered to subjects with type 1 and type 2 diabetes, respectively.

Interventions

insulin degludec

Three single doses administrated subcutaneously (s.c., under the skin) on three separate dosing visits. Dose will vary when administered to subjects with type 1 and type 2 diabetes, respectively.

Intervention Type: DRUG

insulin glargine

Three single doses administrated subcutaneously (s.c., under the skin) on three separate dosing visits. Dose will vary when administered to subjects with type 1 and type 2 diabetes, respectively.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Glycosylated haemoglobin (HbA1c) below or equal to 10 procent based on central laboratory results
• 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)
• 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
• Therapy with oral antidiabetic drugs within the past 3 months prior to screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Neuss, , Germany

Countries

Germany

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

2006-001915-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN5401-1719

Identifier Type: -

Identifier Source: org_study_id