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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01865292

Enrollment

Registered

2013-05-30

Start date

2006-08-31

Completion date

2006-11-30

Last updated

2015-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGinsulin 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.

DRUGinsulin 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 69 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Area under the glucose infusion rate curve	0-24 hours after dosing

Secondary

Measure	Time frame
Area under the insulin degludec/insulin glargine curve	0-96 hours after dosing

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026