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Completed

NCT Number: NCT01682902

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Atlanta, Georgia, 30318, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Faster-acting insulin aspart

Drug

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 names: NN1218

insulin aspart

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Self-measured plasma glucose (SMPG) 7-point profile

    Time frame: After the first, the second, and the third 14-day treatment period

  2. Self-measured plasma glucose (SMPG) 9-point profile

    Time frame: After the first, the second, and the third 14-day treatment period

  3. Number of adverse events (AEs) (including infusion site reactions/infections)

    Time frame: Days 0-14 for each treatment periods

  4. Number of hypoglycaemic episodes

    Time frame: Days 0-14 for each treatment period

  5. Number of unexplained self-reported episodes of hypoglycaemia or hyperglycaemia (confirmed by SMPG)

    Time frame: Days 0-14 for each treatment period

  6. Number of episodes of infusion set occlusions

    Time frame: Days 0-14 for each treatment period

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 11, 2012
Registry last updated
Jan 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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