A Study of LY900014 in a Medtronic Pump

Type1 Diabetes Mellitus Clinical Trial

Official title:

Evaluation of LY900014 in a Medtronic Pump

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03760640
• Other study ID #: 16917
• Secondary ID: I8B-MC-ITSM
• Status: Completed
• Phase: Phase 2
• Start date: February 18, 2019
• Est. completion date: October 7, 2019

Study information

• Verified date: October 15, 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 7, 2019
• Est. primary completion date: October 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type1 Diabetes Mellitus

Intervention

Drug:
• LY900014
Administered SC
• Insulin Lispro
Administered SC

Locations

Country	Name	City	State
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	International Diabetes Center	Saint Louis Park	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean Sensor Glucose Value (24-Hour)	LS mean was determined by MMRM with baseline, period, sequence, strata (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	Percentage of Time Spent in Auto Mode	LS mean was determined by MMRM with baseline, period, sequence, strata (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	Percentage of Time With Sensor Glucose Values <54 mg/dL (24-Hour)	LS mean was determined by MMRM with baseline, period, sequence, strata (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	Rate of Severe Hypoglycemic Events	Severe hypoglycemic is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience coma with or without seizures, and may require parenteral therapy. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within a treatment group *36525. No severe hypoglycemia was reported for this study.	Week 2 through Week 4
Secondary	Total Daily Insulin Dose	LS mean was determined by MMRM with baseline, period, sequence, strata (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