Recent Updates
Recently added Catalysts

injected insulin

Phase 3

Diabetes Mellitus | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Sep 17, 2019

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment299

FDA Designations

No designations recorded

Clinical trial landscape

injected insulin · 1 trial · 3 indications

Phase 3 1
NCT00157339Safety and Efficacy of Inhaled Insulin in Patients With Diabetes and Asthma or COPDDiabetes Mellitus
COMPLETED299 Analytics
PHASE3COMPLETED
Safety and Efficacy of Inhaled Insulin in Patients With Diabetes and Asthma or COPD
Diabetes Mellitus
NCT00157339299
Unlock trial analytics

Study Endpoints

Primary Endpoints

To test the hypothesis that the glycemic control achieved with preprandial Human Insulin Inhalation Powder is noninferior to that achieved with injectable insulin, as measured by mean change from baseline to endpoint in HbA1c.
12 months

Secondary Endpoints

To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on FEV1 and FVC before and after inhalation of bronchodilator.
12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on the response to bronchodilator as measured by change between pre- and post- bronchodilator FEV1 and FVC
12 months
To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on DLco.
12 months
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Human Insulin Inhalation PowderDRUGpatient specific dose, inhaled, before meals, 12 months
injected insulinDRUGpatient specific dose, injected, before meals, 12 months.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites101

Inclusion Criteria: * Type 1 or type 2 diabetes * asthma or COPD Exclusion Criteria: * Current smoking habit

Countries:United StatesArgentinaBulgariaCanadaChileColombiaCroatiaHong KongHungaryIndiaMexicoPhilippinesPuerto RicoSingaporeTaiwanThailand
Unlock Eligibility Criteria

Frequently asked questions about injected insulin

What is injected insulin used for?

Injected insulin is used for the treatment of Diabetes Mellitus. It is being developed by Eli Lilly and Company as a small molecule therapy for this metabolic condition. The drug is currently in Phase 3 clinical development and remains investigational, meaning it has not yet been approved by regulatory authorities.

Who makes injected insulin?

Eli Lilly and Company (NYSE: LLY) is developing injected insulin. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for Diabetes Mellitus. As a Phase 3 asset, it is still in clinical development and has not received regulatory approval.

What phase is injected insulin in?

Injected insulin is in Phase 3 clinical development. It is an investigational therapy for Diabetes Mellitus being developed by Eli Lilly and Company. The Phase 3 trial has been completed, but the drug has not yet been approved by regulatory authorities and remains under clinical investigation.

What clinical trials is injected insulin in?

Injected insulin has one completed Phase 3 clinical trial, NCT00157339, titled "Safety and Efficacy of Inhaled Insulin in Patients With Diabetes and Asthma or COPD." The trial enrolled 299 participants across multiple countries including the United States, Argentina, Bulgaria, Canada, Chile, Colombia, Croatia, Hong Kong, Hungary, India, Mexico, Philippines, Puerto Rico, Singapore, Taiwan, and Thailand.

Is injected insulin FDA approved?

Injected insulin is not FDA approved. It is an investigational drug in Phase 3 clinical development for Diabetes Mellitus. The completed Phase 3 trial, NCT00157339, evaluated its safety and efficacy, but regulatory approval has not been granted, and the drug remains under clinical investigation.