A Study of LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 187
- Locations
- 31
- Primary Endpoint
- Change From Baseline in Percentage of Time With Continuous Glucose Monitoring (CGM) Sensor Glucose Values Between 70-180 Milligrams/Deciliter (mg/dL) (3.9-10.0 Millimoles/Liter [mmol/L]) (Both Inclusive) During Daytime Period at Week 12
Study Overview
Brief Summary
This study is being done to evaluate glycemic control in participants with type 2 diabetes who are taking mealtime insulin LY900014 in combination with long-acting insulin glargine. Participants will use continuous glucose monitoring (CGM) (Freestyle Libre 14-day system) during the study.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants diagnosed (clinically) with type 2 diabetes mellitus (T2D) for at least 1 year prior to screening.
- •Have been treated with basal-bolus multiple daily injection (MDI) therapy for at least 90 days prior to screening including:
- •Basal insulin glargine U-100, in combination with bolus insulin analog (insulin lispro, insulin aspart, or insulin glulisine) with meals.
- •Participant must have been treated with the same type of allowed bolus insulin analog for at least 30 days prior to screening.
- •Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) for T2D in accordance with local regulations:
- •Dipeptidyl peptidase-4 (DPP-4) inhibitor
- •sodium glucose cotransporter 2 (SGLT2) inhibitor
- •oral glucagon-like peptide 1 (GLP-1) agonist
- •Doses of OAMs are required to have been stable for at least 90 days prior to screening.
- •Participants may be treated with injectable GLP-1 receptor agonist for T2D in accordance with local regulations. The GLP-1 receptor agonist dose is required to have been stable for at least 90 days prior to screening.
- •Have an HbA1c value ≥7.5% and ≤10% according to the central laboratory at screening.
Exclusion Criteria
- •Have been diagnosed at any time with type 1 diabetes mellitus or latent autoimmune diabetes in adults.
- •Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to screening.
- •Have had any episode of hyperglycemic hyperosmolar state or diabetic ketoacidosis within 6 months prior to screening.
- •Have hypoglycemia unawareness as judged by the investigator.
Arms & Interventions
LY900014
LY900014 (100 units/milliliter (U/mL)) is a mealtime insulin administered subcutaneously (SC) 0-2 minutes prior to each meal in combination with insulin glargine (100 U/mL) SC as long-acting insulin. Mealtime (bolus) and long-acting (basal) insulin doses were titrated to achieve glucose targets during the study.
Intervention: LY900014 (Drug)
LY900014
LY900014 (100 units/milliliter (U/mL)) is a mealtime insulin administered subcutaneously (SC) 0-2 minutes prior to each meal in combination with insulin glargine (100 U/mL) SC as long-acting insulin. Mealtime (bolus) and long-acting (basal) insulin doses were titrated to achieve glucose targets during the study.
Intervention: Insulin Glargine (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Percentage of Time With Continuous Glucose Monitoring (CGM) Sensor Glucose Values Between 70-180 Milligrams/Deciliter (mg/dL) (3.9-10.0 Millimoles/Liter [mmol/L]) (Both Inclusive) During Daytime Period at Week 12
Time Frame: Baseline, Week 12
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Time as variables.
Secondary Outcomes
- Change From Baseline in Percentage of Time With CGM Sensor Glucose Values Between 70-180 mg/dL (3.9-10.0 mmol/L) (Both Inclusive) During the 24-hour Period at Week 12(Baseline, Week 12)
- Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12(Baseline, Week 12)
- Change From Baseline in Percentage of Time With CGM Sensor Glucose Values <54 mg/dL (<3.0 mmol/L) During Daytime and 24-hour Periods at Week 12(Baseline, Week 12)
- Change From Baseline in Percentage of Time With CGM Sensor Glucose Values >180 mg/dL (>10.0 mmol/L) During Daytime and 24-hour Period at Week 12(Baseline, Week 12)
- Change From Baseline in Percentage of Time With CGM Sensor Glucose Value >250 mg/dL (>13.9 mmol/L) During Daytime and 24-hour Period at Week 12(Baseline, Week 12)
- Change From Baseline in Postprandial Incremental Area Under the Glucose Curve (iAUC) 0-1 Hour at Week 12(Baseline, Week 12)
- Change From Baseline in Postprandial Incremental Area Under the Glucose Curve (iAUC) 0-2 Hour at Week 12(Baseline, Week 12)
- Percentage of Participants With HbA1c <7% and ≤6.5%(Week 12)
- Change From Baseline in Daily Insulin Dose at Week 12(Baseline, Week 12)
- Change From Baseline in Bolus/Total Insulin Dose Percentage at Week 12(Baseline, Week 12)
- Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) - Glycemic Control Domain Score at Week 12(Baseline, Week 12)