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LY041001

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment97

FDA Designations

No designations recorded

Clinical trial landscape

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 2
NCT0009951597
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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 used for?

LY041001 is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus. It is in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in a completed clinical trial that enrolled 97 participants.

Who makes LY041001?

LY041001 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The company is conducting clinical research on this investigational drug for Type 2 Diabetes Mellitus.

What phase is LY041001 in?

LY041001 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. One Phase 2 trial has been completed, and the drug remains under investigation for Type 2 Diabetes Mellitus.

What clinical trials is LY041001 in?

LY041001 has one completed clinical trial registered under NCT00099515. This Phase 2 study, titled 'Comparing Intensive and Standard Training for Human Insulin Inhalation Powder (HIIP),' enrolled 97 participants with Type 2 Diabetes Mellitus across the United States, Argentina, Portugal, and South Africa.

Is LY041001 the same as human insulin inhalation powder?

LY041001 is associated with a clinical trial that compares intensive and standard training for human insulin inhalation powder (HIIP). The trial evaluates training methods for HIIP, and LY041001 is the drug being studied in this context for Type 2 Diabetes Mellitus.