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NCT01121276 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01121276
Other study ID # NN1218-3824
Secondary ID U1111-1113-68972
Status Completed
Phase Phase 1
First received May 10, 2010
Last updated January 16, 2017
Start date April 2010
Est. completion date September 2010

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 82
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Faster-acting insulin aspart
0.2 U/kg body weight injected subcutaneously (under the skin)
• insulin aspart
0.2 U/kg body weight injected subcutaneously (under the skin)
• Faster-acting insulin aspart
0.2 U/kg body weight injected subcutaneously (under the skin)
• Faster-acting insulin aspart
0.2 U/kg body weight injected subcutaneously (under the skin)
• Faster-acting insulin aspart
0.2 U/kg body weight injected subcutaneously (under the skin)

Locations
Country Name City State
United States Novo Nordisk Investigational Site Chula Vista California

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (1)

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)

Outcome
Type Measure Description Time frame Safety issue
Primary Area under the blood glucose concentration-time curve from 0-2 hours
Secondary Area under the blood glucose concentration-time curve from 0-6 hours
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