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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Randomised, Double-Blind, Single Dose, Six-Period Cross-over Dose Response Trial Comparing the Pharmacodynamics and Pharmacokinetics of Insulin 454 With Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01865292
• Other study ID #: NN5401-1719
• Secondary ID: 2006-001915-31
• Status: Completed
• Phase: Phase 1
• First received: May 27, 2013
• Last updated: October 16, 2015
• Start date: August 2006
• Est. completion date: November 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 69 Years

Eligibility

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

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
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
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.

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 after dosing	No
Secondary	Area under the insulin degludec/insulin glargine curve		0-96 hours after dosing	No

External Links

•   Clinical Trials at Novo Nordisk