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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01682902
First received: August 31, 2012
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Drug: NN1218
Drug: insulin aspart
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Mean change in plasma glucose concentration [ Time Frame: From 0-2 hours after administration of standardised meal after the first, the second, and the third 14-day treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-measured plasma glucose (SMPG) 7-point profile [ Time Frame: After the first, the second, and the third 14-day treatment period ] [ Designated as safety issue: No ]
  • Self-measured plasma glucose (SMPG) 9-point profile [ Time Frame: After the first, the second, and the third 14-day treatment period ] [ Designated as safety issue: No ]
  • Number of adverse events (AEs) (including infusion site reactions/infections) [ Time Frame: Days 0-14 for each treatment periods ] [ Designated as safety issue: No ]
  • Number of hypoglycaemic episodes [ Time Frame: Days 0-14 for each treatment periods ] [ Designated as safety issue: No ]
  • Number of unexplained self-reported episodes of hypoglycaemia or hyperglycaemia (confirmed by SMPG) [ Time Frame: Days 0-14 for each treatment periods ] [ Designated as safety issue: No ]
  • Number of episodes of infusion set occlusions [ Time Frame: Days 0-14 for each treatment periods ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: September 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formulation 1 Drug: NN1218
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.
Experimental: Formulation 2 Drug: NN1218
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.
Active Comparator: Insulin aspart (NovoLog®) Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682902

Locations
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Atlanta, Georgia, United States, 30318
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Eva Gunge Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01682902     History of Changes
Other Study ID Numbers: NN1218-3930, U1111-1121-5106
Study First Received: August 31, 2012
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014