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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

Pivotal Trial

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

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

Diarrhoea

Nasopharyngitis

Sinusitis

Syncope

Carpal tunnel syndrome

Lumbar radiculopathy

Acute myocardial infarction

100%

80%

60%

40%

20%

Study treatment Arm

Insulin Lispro (Humalog) Maximum Extended Enrollment (MEE)

Insulin Lispro (Humalog) Lead-In Maximum Extended Enrollment

LY900014

Insulin Lispro (Humalog) Lead-In

Insulin Lispro (Humalog)

LY900014 (MEE)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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