Back to results

Investigation of the Response Relationship of NN5401 in Type 1 Diabetics

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

insulin degludec/insulin aspart

biphasic insulin aspart 30

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
Body mass index 18.0-28.0 kg/m^2 (both inclusive)

Exclusion Criteria:

Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic
Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

IDegAsp low

IDegAsp middle

IDegAsp high

BIAsp 30 low

BIAsp 30 middle

BIAsp 30 high

Arm Description

Outcomes

Primary Outcome Measures

Area (AUC) under the glucose infusion rate curve

Secondary Outcome Measures

Area (AUC) under the insulin aspart concentration time curve

Full Information

NCT ID

NCT00993096

First Posted

October 8, 2009

Last Updated

February 9, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT00993096

Brief Title

Investigation of the Response Relationship of NN5401 in Type 1 Diabetics

Official Title

A Trial Investigating the Pharmacodynamic Response of NN5401 in Subjects With Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (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 was conducted in Europe. The aim of this clinical trial was to evaluate the pharmacodynamic dose-response relationship of NN5401 (insulin degludec/insulin aspart) at three therapeutically relevant doses in subjects with type 1 diabetes. The trial is designed as a four period, incomplete block cross-over trial where the trial participant will be randomised to a treatment sequence by which the subject will receive two matched dose levels of NN5401 and biphasic insulin aspart, respectively.

6. Conditions and Keywords

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

Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IDegAsp low

Arm Type

Experimental

Arm Title

IDegAsp middle

Arm Type

Experimental

Arm Title

IDegAsp high

Arm Type

Experimental

Arm Title

BIAsp 30 low

Arm Type

Experimental

Arm Title

BIAsp 30 middle

Arm Type

Experimental

Arm Title

BIAsp 30 high

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

insulin degludec/insulin aspart

Intervention Description

Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin)

Intervention Type

Drug

Intervention Name(s)

insulin degludec/insulin aspart

Intervention Description

Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin)

Intervention Type

Drug

Intervention Name(s)

insulin degludec/insulin aspart

Intervention Description

Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)

Intervention Type

Drug

Intervention Name(s)

biphasic insulin aspart 30

Intervention Description

Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin)

Intervention Type

Drug

Intervention Name(s)

biphasic insulin aspart 30

Intervention Description

Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin)

Intervention Type

Drug

Intervention Name(s)

biphasic insulin aspart 30

Intervention Description

Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)

Primary Outcome Measure Information:

Title

Area (AUC) under the glucose infusion rate curve

Time Frame

From 0 to 24 hours after single-dose administration

Secondary Outcome Measure Information:

Title

Area (AUC) under the insulin aspart concentration time curve

Time Frame

From 0 to 24 hours after single-dose administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months Body mass index 18.0-28.0 kg/m^2 (both inclusive) Exclusion Criteria: Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

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:

Facility Name

Novo Nordisk Investigational Site

City

Neuss

ZIP/Postal Code

41460

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

25772444

Citation

Heise T, Nosek L, Klein O, Coester H, Svendsen AL, Haahr H. Insulin degludec/insulin aspart produces a dose-proportional glucose-lowering effect in subjects with type 1 diabetes mellitus. Diabetes Obes Metab. 2015 Jul;17(7):659-64. doi: 10.1111/dom.12463. Epub 2015 May 1.

Results Reference

result

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

Investigation of the Response Relationship of NN5401 in Type 1 Diabetics

We'll reach out to this number within 24 hrs