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LY041001

Phase 4

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Trials Updated: Dec 21, 2007

LY041001 development status

Highest phase Phase 4 (NCT00985712)
Phase scored for LLYPhase 2
Registered trials 6 across 3 sponsors since Jun 2008

LY041001 target and mechanism

ModalitySmall molecule

Also known as LY041001 (HIIP), Human Insulin Inhalation Powder, Human Regular U-500 Insulin, Humulin R, U-500R, Huminsulin Regular, Huminsulin Normal, Humulin R U-500

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment97

FDA Designations

No designations recorded

LY041001 clinical trials

LY041001 · 1 trial · 1 indication

Phase 2 1
NCT00099515Comparing Intensive and Standard Training for Human Insulin Inhalation Powder (HIIP)Diabetes Mellitus, Type 2
COMPLETED97 Analytics
PHASE2COMPLETED
Comparing Intensive and Standard Training for Human Insulin Inhalation Powder (HIIP)
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Hypothesis that std training for HIIP system is noninferior to intensive training by 1.2 mmol/L with respect to overall 2-hr postprandial glucose excursion of (SMBG) in type 2 diabetes patients that have been on preprandial trmt with HIIP
4 weeks

Secondary Endpoints

Assess the suitability of the HIIP delivery system for type 2 diabetes patients
4 weeks
Compare the SMBG profiles of preprandial HIIP administration with standard training and with intensive training Assess patient compliance with the HIIP delivery system Directions for Use (DFU) provided by the Sponsor with and without intensive training
4 weeks
Compare the test meal blood glucose profiles of preprandial HIIP administration with standard training and with intensive training
4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -
BEXPERIMENTAL -

Interventions

NameTypeDescription
LY041001 (HIIP)DRUGInhalation, capsule, TID 3 times per day min 6 IU max 60 IU
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Type 2 diabetes for at least 12 months * Age 18 or older. * Taking at least 1 oral antihyperglycemic medication. * Have an HbA1C between 7.5 and 12. * Be a nonsmoker Exclusion Criteria: * Body Mass Index (BMI) greater than 40. * Have frequent episodes of severe hypoglycemia....

Countries:United StatesArgentinaPortugalSouth Africa
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Frequently asked questions about LY041001

What is LY041001?

LY041001 is an investigational small molecule developed by Eli Lilly and Company for type 2 diabetes mellitus. It is also known as LY041001 (HIIP), a human insulin inhalation powder. It has been studied in a Phase 2 clinical trial and is not described as approved.

What is LY041001 used for in type 2 diabetes?

LY041001 was studied for the treatment of type 2 diabetes mellitus. The single Phase 2 trial evaluated intensive versus standard training for human insulin inhalation powder in adults with this condition. It is an investigational agent, and no approved use has been established for it.

Who makes LY041001?

LY041001 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the Phase 2 study of the human insulin inhalation powder in type 2 diabetes.

What phase is LY041001 in?

LY041001 is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are listed. The study enrolled 97 participants and was randomized and controlled, though it was not double blind.

What clinical trial is LY041001 in?

LY041001 has been studied in one Phase 2 trial, NCT00099515, titled Comparing Intensive and Standard Training for Human Insulin Inhalation Powder (HIIP). The completed trial enrolled 97 adults with type 2 diabetes across the United States, Argentina, Portugal, and South Africa, and it was randomized and controlled.

Is LY041001 the same as HIIP?

Yes, LY041001 is also known as LY041001 (HIIP), where HIIP stands for human insulin inhalation powder. The Phase 2 trial NCT00099515 used this HIIP designation in its title while studying adults with type 2 diabetes.