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BioChaperone insulin lispro

Phase 1

Type 1 Diabetes Mellitus | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Nov 22, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

BioChaperone insulin lispro · 2 trials · 2 indications

Phase 1 2
NCT02562313A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®Type 1 Diabetes Mellitus
COMPLETED80 Analytics
NCT02562326A Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 2 Diabetes MellitusType 2 Diabetes Mellitus
COMPLETED51 Analytics
PHASE1COMPLETED
A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®
Type 1 Diabetes MellitusUnlock trial analytics
PHASE1COMPLETED
A Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 2 Diabetes Mellitus
Type 2 Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacodynamics: ΔAUCBG 0-2h
2 Hours

Incremental Area Under the Blood Glucose concentration-time Curve from 0-2 hours after the start of the meal.

Pharmacokinetics: AUClis 0-30min
30 minutes

Area Under the serum insulin Lispro concentration-time Curve from 0-30 minutes

Secondary Endpoints

AUClis_0-6h
up to 6 Hours
Cmax
up to 6 Hours
tCmax
up to 6 Hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BioChaperone insulin lisproEXPERIMENTAL -
Humalog®ACTIVE_COMPARATORInsulin lispro

Interventions

NameTypeDescription
BioChaperone insulin lisproDRUGBioChaperone insulin lispro bolus infusion followed by test meal intake
Humalog®DRUGHumalog® bolus infusion followed by test meal intake
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Type 1 diabetes for at least 12 months * Body Mass Index (BMI) between 18.5 and 28.5 kg/m\^2, both inclusive * Using or having used a Roche CSII system (Accu-Chek® Spirit Combo/ Accu- Chek® Spirit) for at least 6 months before screening. In Part B subjects using any form of CS...

Countries:Germany
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Frequently asked questions about BioChaperone insulin lispro

What is BioChaperone insulin lispro used for?

BioChaperone insulin lispro is an investigational drug being studied for the treatment of Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus. It is a small molecule being developed by Eli Lilly and Company for use in these metabolic conditions.

What does BioChaperone insulin lispro target?

BioChaperone insulin lispro is a form of insulin lispro, a rapid-acting insulin analog. It is designed to work by mimicking the body's natural insulin to help control blood sugar levels in people with diabetes. The drug is being studied for use in Type 1 and Type 2 diabetes.

Who makes BioChaperone insulin lispro?

BioChaperone insulin lispro is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is currently in Phase 1 clinical development for the treatment of Type 1 and Type 2 diabetes.

What phase is BioChaperone insulin lispro in?

BioChaperone insulin lispro is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of Type 1 and Type 2 Diabetes Mellitus.

What clinical trials is BioChaperone insulin lispro in?

BioChaperone insulin lispro has been studied in two completed Phase 1 clinical trials. NCT02562313 investigated continuous subcutaneous insulin infusion of a liquid formulation compared to Humalog in patients with Type 1 diabetes. NCT02562326 investigated efficacy, pharmacokinetics, safety, and tolerability compared to Humalog U-100 in patients with Type 2 diabetes.

Is BioChaperone insulin lispro the same as Humalog?

BioChaperone insulin lispro is not the same as Humalog, but it is being studied in comparison to Humalog. BioChaperone insulin lispro is an investigational drug that combines insulin lispro with a BioChaperone technology, while Humalog is an approved insulin lispro product. The two drugs have been compared in clinical trials for diabetes treatment.