A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682902
• Other study ID #: NN1218-3930
• Secondary ID: U1111-1121-5106
• Status: Completed
• Phase: Phase 1
• First received: August 31, 2012
• Last updated: January 6, 2017
• Start date: September 2012
• Est. completion date: March 2013

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in the United States of America (USA). The aim of the trial is to evaluate continuous subcutaneous infusion of NN1218 formulations and NovoLog® in subjects with type 1 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Type 1 diabetes mellitus (diagnosed clinically) for at least 12 months prior to the screening visit (Visit 1)

• Treatment with the same insulin analogue by CSII (continuous subcutaneous insulin infusion) for the previous 3 months prior to the screening visit (Visit 1)

• Using a MiniMed Paradigm® pump (515/715, 522/722 or 523/723) for the previous 6 months prior to the screening visit (Visit 1)

• Glycosylated haemoglobin (HbA1c) below or equal to 9.0% by central laboratory

• Body Mass Index (BMI) below or equal to 35.0 kg/m^2

Exclusion Criteria:

• History of diabetic ketoacidsosis (DKA) episodes requiring hospitalization within 6 months prior to the screening visit (Visit 1)

• History of abscess at the infusion site within 6 months prior to the screening visit (Visit 1)

• Hypoglycaemic unawareness as judged by the Investigator or history of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to the screening visit (Visit 1)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Faster-acting insulin aspart
Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period.
• Faster-acting insulin aspart
Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period.
• insulin aspart
Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period.

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bode BW, Johnson JA, Hyveled L, Tamer SC, Demissie M. Improved Postprandial Glycemic Control with Faster-Acting Insulin Aspart in Patients with Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion. Diabetes Technol Ther. 2017 Jan 5. doi: 10.1089

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in plasma glucose concentration		From 0-2 hours after administration of standardised meal after the first, the second, and the third 14-day treatment period	No
Secondary	Self-measured plasma glucose (SMPG) 7-point profile		After the first, the second, and the third 14-day treatment period	No
Secondary	Self-measured plasma glucose (SMPG) 9-point profile		After the first, the second, and the third 14-day treatment period	No
Secondary	Number of adverse events (AEs) (including infusion site reactions/infections)		Days 0-14 for each treatment periods	No
Secondary	Number of hypoglycaemic episodes		Days 0-14 for each treatment period	No
Secondary	Number of unexplained self-reported episodes of hypoglycaemia or hyperglycaemia (confirmed by SMPG)		Days 0-14 for each treatment period	No
Secondary	Number of episodes of infusion set occlusions		Days 0-14 for each treatment period	No

External Links

•   Clinical Trials at Novo Nordisk