Type 1 Diabetes
Conditions
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.
Interventions
DRUGLY900014
Administered SC
DRUGInsulin Degludec
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Insulin to Carbohydrate Ratio (ICR) | Day 46 | ICR was evaluated to estimate how many carbohydrates will be covered by one unit of insulin. |
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LY900014 + Insulin Degludec LY900014 (100 U/mL) is a prandial insulin administered 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 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. | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | LY900014 + Insulin Degludec |
|---|---|
| Age, Continuous | 42.20 years STANDARD_DEVIATION 13.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 31 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
Primary
Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM)
Percentage of Time with Sensor Glucose Values Between 70 and 180 mg/dL (both inclusive) with CGM.
Time frame: Day 46
Population: All participants who received at least one dose of study drug and had post-baseline sensor glucose values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY900014 + Insulin Degludec | Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM) | Day-time | 71.57 percentage of time | Standard Deviation 14.37 |
| LY900014 + Insulin Degludec | Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM) | Night-time | 65.76 percentage of time | Standard Deviation 19.846 |
| LY900014 + Insulin Degludec | Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM) | 24-Hour Period | 70.18 percentage of time | Standard Deviation 14.589 |
Secondary
Insulin to Carbohydrate Ratio (ICR)
ICR was evaluated to estimate how many carbohydrates will be covered by one unit of insulin.
Time frame: Day 46
Population: All participants who received at least one dose of study drug and had post-baseline ICR values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY900014 + Insulin Degludec | Insulin to Carbohydrate Ratio (ICR) | Breakfast | 9.03 grams per insulin unit (g/U) | Standard Deviation 3.49 |
| LY900014 + Insulin Degludec | Insulin to Carbohydrate Ratio (ICR) | Lunch | 9.07 grams per insulin unit (g/U) | Standard Deviation 3.423 |
| LY900014 + Insulin Degludec | Insulin to Carbohydrate Ratio (ICR) | Dinner | 9.11 grams per insulin unit (g/U) | Standard Deviation 3.529 |
| LY900014 + Insulin Degludec | Insulin to Carbohydrate Ratio (ICR) | Across meals | 9.05 grams per insulin unit (g/U) | Standard Deviation 3.398 |
Secondary
Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD)
ICR×TDD is determined to evaluate the relationship between insulin to carbohydrate ratio (g/U) and the total daily insulin dose (U/day).
Time frame: Day 46
Population: All participants who received at least one dose of study drug and had post-baseline values for ICR and TDD.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LY900014 + Insulin Degludec | Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD) | Dinner | 427.6 g/day | Standard Deviation 206.98 |
| LY900014 + Insulin Degludec | Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD) | Breakfast | 411.1 g/day | Standard Deviation 169.77 |
| LY900014 + Insulin Degludec | Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD) | Lunch | 421.3 g/day | Standard Deviation 184.18 |
| LY900014 + Insulin Degludec | Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD) | Across meals | 420.0 g/day | Standard Deviation 183.52 |
Secondary
Ratio of Prandial Dose to Total Daily Dose (TDD) of Insulin
Prandial:TDD ratio
Time frame: Day 46
Population: All participants who received at least one dose of study drug and had post-baseline values for prandial and total daily insulin dose.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LY900014 + Insulin Degludec | Ratio of Prandial Dose to Total Daily Dose (TDD) of Insulin | 52.06 percentage of insulin dose | Standard Deviation 12.282 |