A Study of LY900014 and Insulin Lispro With an External Continuous Subcutaneous Insulin Infusion System in Adult Participants With Type 1 Diabetes

NCT03433677 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: 16908I8B-MC-ITSI2017-002374-39
• Study Type: interventional
• Target: 49
• Locations: 2 countries
• Sites: 5

Brief Summary

The purpose of this study is to evaluate the compatibility and safety of LY900014 and insulin lispro with an external continuous subcutaneous insulin infusion system in adult participants with type 1 diabetes.

Conditions

Diabetes Type 1

Keywords

insulin pump

Outcome Measures

Primary Outcomes (1)

• Rate of Infusion Set Failures

  Infusion set failure events are defined as premature infusion set changes, due to a pump occlusion alarm OR due to unexplained hyperglycemia with blood glucose (SMBG) \>250 milligrams per deciliter (mg/dL) (13.9 millimoles per liter \[mmol/L\]) that does not decrease within 1 hour following a correction bolus delivered via the pump during the 6 week treatment period. Aggregate rate was calculated for each participant as the total number of events while the participant is on study treatment divided by the days of exposure \[last dose date and time -first dose date and time -duration of pump or treatment interruption\] times 30.

  6 Weeks

Secondary Outcomes (6)

• Percentage of Participants With at Least 1 Event of Infusion Set Failure

  6 Weeks

• Rate of Premature Infusion Set Changes

  6 Weeks

• Time Interval Until Infusion Set Change

  6 Weeks

• Ratio of Bolus/Total Insulin Dose

  6 Weeks

• Interstitial Glucose Reduction Rate From Hyperglycemia Following a Non-Meal-Related Correction Bolus Delivered Via the Pump

  6 Weeks

Study Arms (2)

LY900014

EXPERIMENTAL

100 units per milliliter (U/mL) LY900014 administered by individualized, continuous, subcutaneous insulin infusion (CSII)

Drug: LY900014

Insulin Lispro

EXPERIMENTAL

100 U/mL insulin lispro (Humalog®) administered by individualized CSII

Drug: Insulin lispro

Interventions

LY900014 DRUG

Administered by CSII

Also known as: Ultra-Rapid Lispro

LY900014

Insulin lispro DRUG

Administered by CSII

Also known as: Humalog

Insulin Lispro

Eligibility Criteria

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

You may qualify if:

• Diagnosed with type 1 diabetes and have been using insulin continuously for at least 12 months.
• Using an insulin pump with 'rapid-acting insulin' for at least 6 months and using the same rapid-acting insulin for at least the past 30 days.
• Have experience using Continuous Glucose Monitoring (CGM) or Flash Glucose Monitoring (FGM) for at least 60 days during the past 12 months.
• Have hemoglobin A1c values ≤8.5%, as determined by the central laboratory at screening.
• Have a body mass index (BMI) of ≤35 kilograms per meter squared at screening.
• Have been using the MiniMed 530G or 630G (US) or the MiniMed 640G (EU) insulin pump for at least the past 30 days.

You may not qualify if:

• Have had more than 1 emergency treatment for very low blood glucose in the last 6 months.
• Have had more than 1 emergency treatment for poor glucose control (hyperglycemia or diabetic ketoacidosis) in the last 6 months.
• Have significant insulin resistance defined as having received a total daily dose of insulin \>1.2 units per kilogram (U/kg) at screening, as determined by the average total daily insulin dose over the 3 days prior to screening divided by weight in kilograms based on investigator review of the participant's pump history.
• Have significant lipohypertrophy, lipoatrophy, or scars within the subcutaneous tissue in areas of infusion or have a history of abscess at an infusion site within the last 90 days prior to screening.
• Are receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than rapid-acting analog insulin via CSII in the 90 days prior to screening. Occasional pen or syringe injection of insulin is allowed, for example, due to pump malfunction or unexplained hyperglycemia not responsive to pump correction bolus.
• Taking certain diabetes medications that are not allowed for study participation.
• Have major problems with heart, kidneys, liver, or have a blood disorder.
• Have had or are now being treated for certain types of cancer that prevents study participation.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (5)

Valley Research

Fresno, California, 93720, United States

Location

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80045, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Seville, 41003, Spain

Location

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

Seville, 41009, Spain

Location

Related Links

• A Study of LY900014 and Insulin Lispro With an External Continuous Subcutaneous Insulin Infusion System in Adult Participants With Type 1 Diabetes (PRONTO-Pump)

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

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

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

Clinicaltrials.gov@lilly.com

800-545-5979

Study Officials

• 1-877-CTLILLY (1-877-285-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 14, 2018
• Study Start: February 21, 2018
• Primary Completion: September 4, 2018
• Study Completion: September 4, 2018
• Last Updated: October 8, 2019
• Results First Posted: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

US (3); ES (2)