A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes
- Registration Number
- NCT04585776
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
In this study, participants with type 1 diabetes (T1D) will take the study drug LY900014 and insulin degludec. The reason for this study is to evaluate the amount of time with glucose values within target range.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- Participants must have type 1 diabetes and have been treated with insulin therapy for at least 1 year
- Participants must be using Continuous Glucose Monitoring (CGM) with total CGM use ≥ 2 months in the prior 6 months
- Participants must have been on the same type of short acting insulin (Humalog U-100, Novolog, Admelog, or Apidra) for at least 30 days prior to screening
- Participants must have been treated with long-acting insulin degludec U-100 for at least 30 days prior to screening
- Participants must not have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months before screening
- Participants must not have had more than 1 episode of severe hypoglycemia within the last 90 days prior to screening
- Participants must not be taking certain diabetes medications that are not allowed for study participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LY900014 + Insulin Degludec LY900014 LY900014 (100 units/milliliter (U/mL)) is a prandial insulin administered subcutaneously (SC) 0-2 minutes before meals. Insulin degludec (100 U/mL) is a basal insulin administered once daily SC. Participants received individually adjusted insulin doses during the 35-day titration period. The target glucose values were: fasting glucose 80-110 milligrams per deciliter (mg/dL), overnight glucose excursion (the difference between bedtime and prebreakfast glucose levels) \< or = +/- 30 mg/dL, postprandial glucose peak \<140 mg/dL or \<20% increase from premeal level. Following the titration period, there was an 11-day maintenance period during which the doses were kept unchanged unless for safety reasons. LY900014 + Insulin Degludec Insulin Degludec LY900014 (100 units/milliliter (U/mL)) is a prandial insulin administered subcutaneously (SC) 0-2 minutes before meals. Insulin degludec (100 U/mL) is a basal insulin administered once daily SC. Participants received individually adjusted insulin doses during the 35-day titration period. The target glucose values were: fasting glucose 80-110 milligrams per deciliter (mg/dL), overnight glucose excursion (the difference between bedtime and prebreakfast glucose levels) \< or = +/- 30 mg/dL, postprandial glucose peak \<140 mg/dL or \<20% increase from premeal level. Following the titration period, there was an 11-day maintenance period during which the doses were kept unchanged unless for safety reasons.
- Primary Outcome Measures
Name Time Method Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM) Day 46 Percentage of Time with Sensor Glucose Values Between 70 and 180 mg/dL (both inclusive) with CGM.
- Secondary Outcome Measures
Name Time Method Ratio of Prandial Dose to Total Daily Dose (TDD) of Insulin Day 46 Prandial:TDD ratio
Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD) Day 46 ICR×TDD is determined to evaluate the relationship between insulin to carbohydrate ratio (g/U) and the total daily insulin dose (U/day).
Insulin to Carbohydrate Ratio (ICR) Day 46 ICR was evaluated to estimate how many carbohydrates will be covered by one unit of insulin.
Trial Locations
- Locations (3)
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
Iowa Diabetes and Endocrinology Research Center
🇺🇸West Des Moines, Iowa, United States
HealthPartners Institute dba International Diabetes Center
🇺🇸Minneapolis, Minnesota, United States