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A Trial Investigating NN1218 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

United States

Study Type

Interventional

Intervention

Faster-acting insulin aspart

insulin aspart

Faster-acting insulin aspart

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 or type 2 diabetes mellitus for more than 12 months
Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for 12 months or longer for subjects with type 1 diabetes and for 3 months or longer for subjects with type 2 diabetes
Body Mass Index (BMI) between 18.0-32.0 kg/m2 (both inclusive)

Exclusion Criteria:

Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to trial start
Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
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 Type

Experimental

Active Comparator

Arm Label

NN1218, formulation A

NN1218, formulation B

NN1218, formulation C

NN1218, formulation D

insulin aspart

Arm Description

Outcomes

Primary Outcome Measures

Area under the blood glucose concentration-time curve

Secondary Outcome Measures

Area under the blood glucose concentration-time curve

Full Information

NCT ID

NCT01121276

First Posted

May 10, 2010

Last Updated

January 16, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01121276

Brief Title

A Trial Investigating NN1218 in Subjects With Type 1 and Type 2 Diabetes

Official Title

A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 and Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (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 and in the United States of America (USA). The aim of this trial is to investigate the absorption and effect in the body of NN1218 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

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NN1218, formulation A

Arm Type

Experimental

Arm Title

NN1218, formulation B

Arm Type

Experimental

Arm Title

NN1218, formulation C

Arm Type

Experimental

Arm Title

NN1218, formulation D

Arm Type

Experimental

Arm Title

insulin aspart

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Faster-acting insulin aspart

Other Intervention Name(s)

NN1218

Intervention Description

0.2 U/kg body weight injected subcutaneously (under the skin)

Intervention Type

Drug

Intervention Name(s)

insulin aspart

Intervention Description

0.2 U/kg body weight injected subcutaneously (under the skin)

Intervention Type

Drug

Intervention Name(s)

Faster-acting insulin aspart

Other Intervention Name(s)

NN1218

Intervention Description

0.2 U/kg body weight injected subcutaneously (under the skin)

Intervention Type

Drug

Intervention Name(s)

Faster-acting insulin aspart

Other Intervention Name(s)

NN1218

Intervention Description

0.2 U/kg body weight injected subcutaneously (under the skin)

Intervention Type

Drug

Intervention Name(s)

Faster-acting insulin aspart

Other Intervention Name(s)

NN1218

Intervention Description

0.2 U/kg body weight injected subcutaneously (under the skin)

Primary Outcome Measure Information:

Title

Area under the blood glucose concentration-time curve

Time Frame

from 0-2 hours

Secondary Outcome Measure Information:

Title

Area under the blood glucose concentration-time curve

Time Frame

from 0-6 hours

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 or type 2 diabetes mellitus for more than 12 months Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for 12 months or longer for subjects with type 1 diabetes and for 3 months or longer for subjects with type 2 diabetes Body Mass Index (BMI) between 18.0-32.0 kg/m2 (both inclusive) Exclusion Criteria: Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to trial start Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) 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

Chula Vista

State/Province

California

ZIP/Postal Code

91911

Country

United States

12. IPD Sharing Statement

Citations:

Citation

Heise T, Haahr H, Jensen L, Ericsen L, Hompesch M. Faster-acting Insulin Aspart Improves Postprandial Glycemia vs Insulin Aspart in Patients with Type 1 Diabetes Mellitus (T1DM). Diabetes 2014; 63 ((Suppl 1)): A34 (abstract 129-OR)

Results Reference

background

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

A Trial Investigating NN1218 in Subjects With Type 1 and Type 2 Diabetes

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