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Injectable Insulin

Phase 3

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Sep 16, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials3
Total Enrollment949

FDA Designations

No designations recorded

Clinical trial landscape

Injectable Insulin · 4 trials · 2 indications

Phase 3 3Phase 2 1
NCT00356109Evaluate the Efficacy of Insulin Patients With Type 1 DiabetesDiabetes Mellitus, Type 1
COMPLETED494 Analytics
NCT00325364Study of Human Insulin Inhalation Powder in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2
COMPLETED415 Analytics
NCT00127634Study of Human Insulin Inhalation Powder in Patients With Type 1 DiabetesDiabetes Mellitus, Type 1
COMPLETED385 Analytics
PHASE3COMPLETED
Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes
Diabetes Mellitus, Type 1Unlock trial analytics
PHASE3COMPLETED
Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes
Diabetes Mellitus, Type 2Unlock trial analytics
PHASE3COMPLETED
Study of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes
Diabetes Mellitus, Type 1Unlock trial analytics

Study Endpoints

Primary Endpoints

To test that preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint.
6 months
To assess the change in baseline to endpoint in HbA1c in Type II diabetic patients comparing inhaled human insulin to injectable insulin
6 months
To assess change in baseline to endpoint in HbA1c in type 1 diabetic patients.
24 months
Change in HbA1c from baseline
12 and 24 weeks

Secondary Endpoints

Insulin dose requirements
throughout the study
Insulin antibody binding levels
baseline, 1 month, 6 months, follow-up
To compare HbAlc change
6 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Human Insulin Inhalation PowderDRUGpatient specific dose, inhaled, before meals, 6 months
Injectable insulinDRUGpatient specific dose, injected, before meals, 6 months
Insulin GlargineDRUGpatient specific dose, injectable, before meals, 6 months
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites37

Inclusion Criteria: * Type 1 diabetes for at least 24 months * Have an HbA1c less than or equal to 11% * Patients who are on an insulin regimen involving 2 or 3 preprandial injections per day for at least 2 months * Non-smoker Exclusion Criteria: * Require a daily total insulin dosage greater tha...

Countries:United StatesArgentinaBelgiumFranceGermanyIndiaItalyMexicoPuerto RicoBrazilHungaryPolandPortugalTaiwanCanadaCroatiaJapan
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Frequently asked questions about Injectable Insulin

What is Injectable Insulin used for?

Injectable Insulin is used for the treatment of Diabetes Mellitus Type 1 and Diabetes Mellitus Type 2. It is a small molecule metabolic therapy being developed by Eli Lilly and Company. The drug is currently in Phase 3 clinical development for these indications.

Who makes Injectable Insulin?

Injectable Insulin is being developed by Eli Lilly and Company, a pharmaceutical company traded on the stock exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's efficacy in patients with Type 1 and Type 2 diabetes.

What phase is Injectable Insulin in?

Injectable Insulin is in Phase 3 clinical development. Eli Lilly and Company has completed three Phase 3 trials for the drug, studying its use in patients with Type 1 and Type 2 diabetes. The drug remains investigational and is not yet approved for commercial use.

What clinical trials is Injectable Insulin in?

Injectable Insulin has completed three Phase 3 clinical trials: NCT00127634 in Type 1 diabetes with 385 patients, NCT00325364 in Type 2 diabetes with 415 patients, and NCT00356109 in Type 1 diabetes with 494 patients. All trials were completed and enrolled adult patients.

Is Injectable Insulin the same as human insulin inhalation powder?

Injectable Insulin is related to human insulin inhalation powder, as two of its Phase 3 trials studied this formulation. However, the drug name Injectable Insulin refers to the general insulin product being developed by Eli Lilly, and the inhalation powder represents a specific delivery form tested in clinical trials.