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

August 31, 2012
March 18, 2013
September 2012
March 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01682902 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes
A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 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.
  • 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.
  • Experimental: Formulation 1
    Intervention: Drug: NN1218
  • Experimental: Formulation 2
    Intervention: Drug: NN1218
  • Active Comparator: Insulin aspart (NovoLog®)
    Intervention: Drug: insulin aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
March 2013
March 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01682902
NN1218-3930, U1111-1121-5106
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Eva Gunge Novo Nordisk A/S
Novo Nordisk A/S
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP