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

NCT01682902 | Completed Phase 1

• 2 other identifiers: NN1218-3930U1111-1121-5106
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Mean change in plasma glucose concentration

  From 0-2 hours after administration of standardised meal after the first, the second, and the third 14-day treatment period

Secondary Outcomes (6)

• Self-measured plasma glucose (SMPG) 7-point profile

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

• Self-measured plasma glucose (SMPG) 9-point profile

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

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

  Days 0-14 for each treatment periods

• Number of hypoglycaemic episodes

  Days 0-14 for each treatment period

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

  Days 0-14 for each treatment period

Study Arms (3)

Formulation 1

EXPERIMENTAL

Drug: Faster-acting insulin aspart

Formulation 2

EXPERIMENTAL

Drug: Faster-acting insulin aspart

Insulin aspart (NovoLog®)

ACTIVE COMPARATOR

Drug: insulin aspart

Interventions

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.

Also known as: NN1218

Formulation 1

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.

Insulin aspart (NovoLog®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Atlanta, Georgia, 30318, United States

Location

Related Publications (1)

• 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.

  PMID: 28055230 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: September 11, 2012
• Study Start: September 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: January 9, 2017

Record last verified: 2017-01

Locations

US (1)