A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes

Phase 3

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: LY900014; Drug: Insulin Lispro; Drug: Insulin Glargine; Drug: Insulin Degludec

• Registration Number: NCT03740919
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) in children and adolescents with type 1 diabetes (T1D).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-12
• Study First Submitted QC: 2018-11-12
• Study First Posted: 2018-11-14
• Study Start: 2019-04-07
• Primary Completion: 2021-07-02
• Study Completion: 2021-07-02
• Status Verified: 2021-12
• Results First Submitted: 2021-12-23
• Results First Submitted QC: 2021-12-23
• Last Update Submitted: 2021-12-23
• Results First Posted: 2022-01-24
• Last Update Posted: 2022-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 751

Inclusion Criteria

• T1D for at least 6 months at the screening visit.

• Have been treated with only one of the following rapid-acting insulin analogs as part of an multiple daily injection regimen for at least the last 90 days prior to the screening visit:

  • insulin lispro U-100, or
  • insulin aspart
  • insulin glulisine or
  • fast acting insulin aspart

• Have been treated with only one of the following basal insulins for at least the last 90 days prior to the screening visit:

  • insulin glargine U-100 (once a day [QD] or twice a day [BID]), or
  • insulin detemir U-100 (QD or BID), or
  • insulin degludec U-100 (QD)

• Have a HbA1c value ≤ 9.9% at the screening visit.

Exclusion Criteria

• Have current hypoglycemic unawareness or have had more than 1 episode of severe hypoglycemia within 6 months prior to the screening visit.
• Have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to the screening visit.
• Have been on a treatment regimen that includes regular human insulin, neutral protamine Hagedorn (NPH), Afrezza® (insulin human) inhalation powder, any premixed insulins or use of diluted insulins within 90 days prior to the screening visit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY900014	LY900014	Participants received 100 U/mL LY900014 administered SC, 0 to 2 minutes before start of the meal.
LY900014 Postmeal	LY900014	Participants received 100 U/mL LY900014 administered SC, up to 20 minutes after the start of the meal.
Insulin Lispro (Humalog)	Insulin Lispro	Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) administered subcutaneously (SC), 0 to 2 minutes before each meal with once or twice daily basal insulin. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
Insulin Lispro (Humalog)	Insulin Glargine	Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) administered subcutaneously (SC), 0 to 2 minutes before each meal with once or twice daily basal insulin. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
Insulin Lispro (Humalog)	Insulin Degludec	Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) administered subcutaneously (SC), 0 to 2 minutes before each meal with once or twice daily basal insulin. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26	Baseline, Week 26	Change from baseline in HbA1c was analyzed using mixed model repeated measures (MMRM) and includes fixed class effects of treatment, strata (pooled country, type of basal insulin, and age group), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. An unstructured covariance structure will be used to model the within-participant errors.; The Efficacy estimand included data collected prior to permanent discontinuation of study drug through Week 26.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Documented Hypoglycemic Events	Baseline through Week 26	Documented hypoglycemia is defined as \<54 mg/dL and ≤70 mg/dL, respectively.
Change From Baseline in HbA1c (Postprandial) at Week 26	Baseline, Week 26	Change from baseline in HbA1c postprandial was analyzed using (MMRM and includes fixed class effects of treatment, strata (pooled country, type of basal insulin, and age group), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. An unstructured covariance structure will be used to model the within-participant errors.; The Efficacy estimand included data collected prior to permanent discontinuation of study drug through Week 26.
Rate of Severe Hypoglycemia	Week 0 through Week 26	Severe hypoglycemia: during these episodes, participants have an altered mental status and cannot assist in their own care, may be semiconscious or unconscious, or experience coma with or without seizures, and require assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.; The rate of severe hypoglycemia per 100 years was calculated as: 100 times the total number of severe hypoglycemia episodes within the period divided by total exposure (in year) for all participants within the treatment group.
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values at Week 26	Baseline, Week 26	Change from baseline in 7-point SMBG values were analyzed using MMRM and includes fixed class effects of treatment, strata (pooled country, type of basal insulin, and age group, and HbA1c stratum (≤8.0%, \>8.0%)) baseline value, visit, and treatment-by-visit interaction. An unstructured covariance structure was used to model the within-participant errors.
Rate of Documented Post-dose Hypoglycemic Events Within 1 and 2 Hours After the Prandial Dose	Baseline through Week 26	Documented post-dose hypoglycemia event is an event of blood glucose of \< 54 mg/dL and ≤70 mg/dL that occurred within 1 and 2 hours after the prandial dose. The rate of documented hypoglycemia was estimated by a negative binomial regression including treatment and age group as independent variable and number of episodes as dependent variables with log (exposure/365.25 days) as the offset in the model.
Change From Baseline in Insulin Dose at Week 26	Baseline, Week 26	Change from baseline in insulin dose was analyzed using mixed model repeated measures (MMRM) and includes fixed class effects of treatment, strata (pooled country, type of basal insulin, age group, and HbA1c stratum (≤8.0%, \>8.0%)), baseline value, visit and treatment-by-visit interaction. An unstructured covariance structure was used to model the within-participant errors.
Percentage of Participants With Documented Post-dose Hypoglycemic Events Within 1 and 2 Hours After the Prandial Dose	Baseline through Week 26	Documented post-dose hypoglycemia \<54 milligrams per deciliter (mg/dL) and ≤ 70 mg/dL that occurred 1 and 2 hours after prandial dose.
Rate of Documented Hypoglycemia Events	Week 0 through Week 26	Documented hypoglycemia is defined as a hypoglycemic event of blood glucose of ≤70 mg/dL or \<54 mg/dL. The rate of documented hypoglycemia was estimated by negative binomial regression including treatment and age group as independent variables and number of episodes as dependent variable with log (exposure/365.25 days) as the offset in the model.
Percentage of Participants With HbA1c < 7.0% and <7.5%	Week 26	Percentage of participants with HbA1c \< 7.0% and \<7.5% was analyzed using a longitudinal logistic regression with repeated measurements conducted by a generalized linear mixed model including independent variables of treatment, baseline HbA1c value, visit, baseline HbA1c-by-visit interaction, and treatment-by-visit interaction. An unstructured covariance structure was used.

Trial Locations

Locations (111)

University of Alabama Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Arizona; 🇺🇸 Tucson, Arizona, United States

Children's Hospital Los Angeles - Dept of Endocrinology; 🇺🇸 Los Angeles, California, United States

Stanford University School of Medicine - Division of Pediatric Endocrinology & Diabetes; 🇺🇸 Palo Alto, California, United States

Center of Excellence in Diabetes & Endocrinology; 🇺🇸 Sacramento, California, United States

Rady Childrens Hospital - San Diego; 🇺🇸 San Diego, California, United States

Barbara Davis Center; 🇺🇸 Aurora, Colorado, United States

Florida Hospital; 🇺🇸 Orlando, Florida, United States

Tallahassee Memorial HealthCare; 🇺🇸 Tallahassee, Florida, United States

University of South Florida Diabetes & Endocrinology Center; 🇺🇸 Tampa, Florida, United States

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