A Study of LY900014 in a Medtronic Pump

NCT03760640 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 16917I8B-MC-ITSM
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare the study drug LY900014 to insulin lispro (Humalog) when both are delivered by the Medtronic MiniMed 670G System in adults with type 1 diabetes (T1D). The study will consist of two treatment periods of 4 weeks.

Conditions

Type1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) (24-Hour)

  Least Square (LS) mean was determined by mixed-model repeated measures (MMRM) with baseline, period, sequence, strata (Hemoglobin A1c (HbA1c) \[\<=7.0%, \>7.0%\] and percentage of time with sensor glucose values from 70 to 180 mg/dL over the 2 weeks prior to randomization \[\<=75%, \>75%\]), treatment (Type III sum of squares) as fixed factors.

  Week 2 through Week 4

Secondary Outcomes (5)

• Mean Sensor Glucose Value (24-Hour)

  Week 2 through Week 4

• Percentage of Time Spent in Auto Mode

  Week 2 through Week 4

• Percentage of Time With Sensor Glucose Values <54 mg/dL (24-Hour)

  Week 2 through Week 4

• Rate of Severe Hypoglycemic Events

  Week 2 through Week 4

• Total Daily Insulin Dose

  Week 2 through Week 4

Study Arms (2)

LY900014

EXPERIMENTAL

Participants received 100 units per milliliter (U/mL) of LY900014 administered via continuous subcutaneous insulin infusion (CSII) by the Medtronic MiniMed 670G insulin pump.

Drug: LY900014

Insulin Lispro (Humalog)

ACTIVE COMPARATOR

Participants received 100 U/mL of Insulin lispro (Humalog) administered via CSII by the Medtronic MiniMed 670G insulin pump.

Drug: Insulin Lispro

Interventions

LY900014 DRUG

Administered SC

Also known as: Ultra-Rapid Lispro, Lyumjev

LY900014

Insulin Lispro DRUG

Administered SC

Also known as: Humalog, LY275585

Insulin Lispro (Humalog)

Eligibility Criteria

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

You may qualify if:

• Participants must have been diagnosed with type 1 diabetes and have been using insulin continuously for at least 12 months
• Participants must be using an insulin pump with "rapid-acting insulin" for at least 6 months and the same "rapid acting insulin" for at least the past 30 days
• Participants must have hemoglobin A1c (HbA1c) values ≥6.0% and ≤8.0%
• Participants must have been using the MiniMed 670G insulin pump for at least the past 90 days
• Participants must use their Guardian (3) sensor at least an average of 75% of the time and remain in Auto Mode an average of 70% of the time

You may not qualify if:

• Participants must not have had more than 1 emergency treatment for very low blood glucose or any hospitalizations for poor glucose control (very high blood sugar or diabetic ketoacidosis) in the last 6 months
• Participants must not have significant abnormal accumulation of fat, loss of fat tissue, or scars just under the skin in areas of infusion or have a history of an infection at an infusion site within 90 days prior to screening
• Participants must not have a total daily insulin dose \>100 units
• Participants must not be receiving any oral or injectable medication intended for the treatment of diabetes other than rapid-acting analog insulin via CSII in the 30 days prior to screening
• Participants must not have major problems with their heart, kidneys, liver, or have a blood disorder

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

International Diabetes Center

Saint Louis Park, Minnesota, 55416, United States

Location

Related Publications (1)

• Bode B, Carlson A, Liu R, Hardy T, Bergenstal R, Boyd J, Morrett S, Ignaut D. Ultrarapid Lispro Demonstrates Similar Time in Target Range to Lispro with a Hybrid Closed-Loop System. Diabetes Technol Ther. 2021 Dec;23(12):828-836. doi: 10.1089/dia.2021.0184. Epub 2021 Oct 26.

  PMID: 34270335 DERIVED

MeSH Terms

Interventions

Insulin Lispro

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

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: November 30, 2018
• Study Start: February 18, 2019
• Primary Completion: October 7, 2019
• Study Completion: October 7, 2019
• Last Updated: October 29, 2020
• Results First Posted: October 29, 2020

Record last verified: 2019-10-15

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 (2)