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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin degludec; Drug: insulin glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01865292

2006-001915-31 (EudraCT Number)

NN5401-1719

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 69 years old

Volunteers: No 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 exclusion criteria for subject with type 2 diabetes:
• Therapy with oral antidiabetic drugs within the past 3 months prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Insulin degludec

Experimental group

Treatment:

Drug: insulin degludec

Insulin glargine

Active Comparator group

Treatment:

Drug: insulin glargine