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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01682902
• Date of registration: 31/08/2012
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes
• Scientific title: A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes
• Date of first enrolment: September 2012
• Target sample size: 43
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01682902
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Global Clinical Registry (GCR, 1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes

Diabetes Mellitus, Type 1

Intervention(s)

Drug: insulin aspart

Drug: Faster-acting insulin aspart

Primary Outcome(s)

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 Outcome(s)

Self-measured plasma glucose (SMPG) 7-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 episodes of infusion set occlusions [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 hypoglycaemic episodes [Time Frame: Days 0-14 for each treatment period]

Self-measured plasma glucose (SMPG) 9-point profile [Time Frame: After the first, the second, and the third 14-day treatment period]

Secondary ID(s)

NN1218-3930

U1111-1121-5106

Source(s) of Monetary Support

Please refer to primary and secondary sponsors