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

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ClinicalTrials.gov Identifier: NCT01682902
Recruitment Status : Completed
First Posted : September 11, 2012
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE August 31, 2012
First Posted Date  ICMJE September 11, 2012
Last Update Posted Date January 9, 2017
Study Start Date  ICMJE September 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2012)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2012)
  • Self-measured plasma glucose (SMPG) 7-point profile [ Time Frame: After the first, the second, and the third 14-day treatment period ]
  • Self-measured plasma glucose (SMPG) 9-point profile [ Time Frame: After the first, the second, and the third 14-day treatment period ]
  • Number of adverse events (AEs) (including infusion site reactions/infections) [ Time Frame: Days 0-14 for each treatment periods ]
  • Number of hypoglycaemic episodes [ Time Frame: Days 0-14 for each treatment period ]
  • Number of unexplained self-reported episodes of hypoglycaemia or hyperglycaemia (confirmed by SMPG) [ Time Frame: Days 0-14 for each treatment period ]
  • Number of episodes of infusion set occlusions [ Time Frame: Days 0-14 for each treatment period ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes
Official Title  ICMJE A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 1
Intervention  ICMJE
  • 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.
    Other Name: NN1218
  • 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.
Study Arms  ICMJE
  • Experimental: Formulation 1
    Intervention: Drug: Faster-acting insulin aspart
  • Experimental: Formulation 2
    Intervention: Drug: Faster-acting insulin aspart
  • Active Comparator: Insulin aspart (NovoLog®)
    Intervention: Drug: insulin aspart
Publications * 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;19(1):25-33. doi: 10.1089/dia.2016.0350. Epub 2017 Jan 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2013)
43
Original Estimated Enrollment  ICMJE
 (submitted: September 7, 2012)
36
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01682902
Other Study ID Numbers  ICMJE NN1218-3930
U1111-1121-5106 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date January 2017

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