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Insulin

LY900014 for Type 2 Diabetes

Phase 3
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

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.

Eligible Conditions
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
Secondary study objectives
Change From Baseline in Bolus/Total Insulin Dose Percentage at Week 12
Change From Baseline in Daily Insulin Dose at Week 12
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
+8 more

Side effects data

From 2019 Phase 3 trial • 933 Patients • NCT03214380
4%
Nasopharyngitis
2%
Upper respiratory tract infection
1%
Diarrhoea
1%
Gastritis
1%
Empyema
1%
Diabetic ulcer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Insulin Lispro (Humalog) Lead-In Maximum Extended Enrollment
Insulin Lispro (Humalog) Maximum Extended Enrollment (MEE)
LY900014
Insulin Lispro (Humalog) Lead-In
Insulin Lispro (Humalog)
LY900014 (MEE)

Trial Design

1Treatment groups
Experimental Treatment
Group I: LY900014Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY900014
2017
Completed Phase 3
~3020
Insulin Glargine
2013
Completed Phase 4
~7140

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,640 Previous Clinical Trials
3,221,457 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,358 Previous Clinical Trials
417,903 Total Patients Enrolled
~39 spots leftby Sep 2025
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