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

Primary Purpose

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

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

insulin degludec

insulin glargine

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insulin degludec

Insulin glargine

Arm Description

Outcomes

Primary Outcome Measures

Area under the glucose infusion rate curve

Secondary Outcome Measures

Area under the insulin degludec/insulin glargine curve

Full Information

NCT ID

NCT01865292

First Posted

May 27, 2013

Last Updated

October 16, 2015

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01865292

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

November 2006 (Actual)

Study Completion Date

November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Insulin degludec

Arm Type

Experimental

Arm Title

Insulin glargine

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

insulin degludec

Intervention Description

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

Intervention Name(s)

insulin glargine

Intervention Description

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.

Primary Outcome Measure Information:

Title

Area under the glucose infusion rate curve

Time Frame

0-24 hours after dosing

Secondary Outcome Measure Information:

Title

Area under the insulin degludec/insulin glargine curve

Time Frame

0-96 hours after dosing

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

City

Neuss

ZIP/Postal Code

41460

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

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