Glycemic Stability of Insulin Aspart Versus Insulin Lispro in Insulin Pump Therapy

NCT00428207 | Terminated Results

• 1 other identifier: 06-18
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine:

1. 1.whether there is a difference between insulin aspart and insulin lispro in continuous insulin pump therapy
2. 2.whether duration of the insulin infusion set placement effect blood sugar control if the infusion set is in place for longer then 72-96 hours

Conditions

Type 1 Diabetes Mellitus

Keywords

type 1 diabetes, insulin pump therapy, glycemic stability

Outcome Measures

Primary Outcomes (1)

• Glycemic Stability

  Glycemic stability will be assessed by MAGE (Mean Amplitude of Glycemic Excursion)(5), M value of Schlichtkrull, standard deviation \& coefficient of variation using 7 point finger stick blood glucose measurements performed 48-96 hours after insertion of the pump infusion catheter. Data collected 48 to 72 hours post-catheter insertion will be analyzed separately from the data collected 72 to 96 hours post-catheter insertion. The mean of the measurements taken throughout the study will be used for calculation of the primary endpoint.

  48 to 96 hours

Secondary Outcomes (1)

• Frequency of Catheter Change

  48 to 96 hours

Study Arms (2)

Insulin Aspart Versus Insulin Lispro

ACTIVE COMPARATOR

Insulin aspart will be used for diabetes management, and will be delivered continuously, subcutaneously using a pump for a four week period. Insulin aspart doses will be adjusted by the principal investigator as needed to maintain glycemic control. Insulin dose adjustments will vary from patient to patient based on the carbohydrate consumption, level of physical activity, and fingerstick monitoring results SMBG (7 times per day). SMBG results collected during this four week period will be compared to the SMBG results collected while participant uses alternative treatment (insulin Lispro).

Drug: Insulin Aspart versus Insulin Lispro

Insulin Lispro Versus Insulin Aspart

ACTIVE COMPARATOR

Insulin lispro will be used for diabetes management, and will be delivered continuously, subcutaneously using a pump for a four week period. Dose will be adjusted as needed to maintain glycemic control. Insulin dose adjustments will vary from patient to patient based on the carbohydrate consumption, level of physical activity, and fingerstick monitoring results SMBG (7 times per day). SMBG results collected during this four week period will be compared to the SMBG results collected while participant uses alternative treatment (insulin Aspart).

Drug: Insulin Lispro versus Insulin Aspart

Interventions

Insulin Aspart versus Insulin Lispro DRUG

Subjects will be randomly assigned to insulin aspart versus insulin lispro via random number generation. Half of the patients will begin with insulin aspart, and then will be crossed over to insulin lispro. The insulin sequence will be reversed for the other half of the patients.

Also known as: NovoLog, NovoRapid, Humalog

Insulin Aspart Versus Insulin Lispro

Insulin Lispro versus Insulin Aspart DRUG

Subjects will be randomly assigned to insulin lispro versus insulin aspart via random number generation. Half of the patients will begin with insulin lispro, and then will be crossed over to insulin aspart. The insulin sequence will be reversed for the other half of the patients.

Also known as: Humalog, NovoRapid, Novolog

Insulin Lispro Versus Insulin Aspart

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 diabetes treated with CSII at least 3 months.
• Males and females, \> 18 years but \< 75 years old.
• Hemoglobin A1c ≤ 8.0 % at measurement taken at week 0 (screening visit).
• Duration of diabetes ≥ 12 months.
• Willingness to perform self-blood glucose monitoring several times/day.

You may not qualify if:

• Previous insulin precipitation in pump infusion catheters.
• Daily insulin requirements \> 25% of pump reservoir capacity. (This would preclude the subject from using the pump infusion system for more than 3 days).
• Use of an insulin pump that does not have a downloadable record of basal and bolus doses.
• Known or suspected allergy to trial products.
• Pregnancy, breast-feeding, intention to become pregnant or inadequate contraception measures.
• Known or suspected alcohol or drug abuse.
• Impaired renal function with creatinine ≥ 1.7 mg/dl.
• Pronounced catheter site scarring.
• Chronic use of drugs that may influence glycemic control (e.g. steroids).
• Any other significant concomitant disease that would interfere with participation in and completion of the trial.

Sponsors & Collaborators

• Joslin Diabetes Center: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Aspart; Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; 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

Limitations and Caveats

The 7 point fingerstick blood glucose profile was not sensitive enough to detect differences in the treatments.

Results Point of Contact

• Title: Howard Wolpert, MD
• Organization: Joslin Diabetes Center

howard.wolpert@joslin.harvard.edu

6173092665

Study Officials

• Howard A Wolpert, MD

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2007
• First Posted: January 29, 2007
• Study Start: February 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: May 30, 2017
• Results First Posted: May 30, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)