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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: Faster-acting insulin aspart; Drug: insulin aspart

• Registration Number: NCT01682902
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-31
• Study Start: 2012-09
• Study First Submitted QC: 2012-09-07
• Study First Posted: 2012-09-11
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-06
• Last Update Posted: 2017-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Formulation 1	Faster-acting insulin aspart	-
Formulation 2	Faster-acting insulin aspart	-
Insulin aspart (NovoLog®)	insulin aspart	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Number of hypoglycaemic episodes	Days 0-14 for each treatment period
Number of unexplained self-reported episodes of hypoglycaemia or hyperglycaemia (confirmed by SMPG)	Days 0-14 for each treatment period
Self-measured plasma glucose (SMPG) 7-point profile	After the first, the second, and the third 14-day treatment period
Self-measured plasma glucose (SMPG) 9-point profile	After the first, the second, and the third 14-day treatment period
Number of adverse events (AEs) (including infusion site reactions/infections)	Days 0-14 for each treatment periods
Number of episodes of infusion set occlusions	Days 0-14 for each treatment period

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Atlanta, Georgia, United States