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Regular insulin

Phase 2

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Becton, Dickinson and Company|Last Updated: Aug 22, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Regular insulin · 1 trial · 1 indication

Phase 2 1
NCT00553488Feasibility Study of the Effect of Intra-Dermal Insulin Injection on Blood Glucose Levels After EatingDiabetes Mellitus, Type 1
COMPLETED30 Analytics
PHASE2COMPLETED
Feasibility Study of the Effect of Intra-Dermal Insulin Injection on Blood Glucose Levels After Eating
Diabetes Mellitus, Type 1Unlock trial analytics

Study Endpoints

Primary Endpoints

Area Under Curve (AUC) of the blood glucose (BG) profile after the meal, with and without baseline correction.
90 mins

Secondary Endpoints

Maximal BG (BGmax)
Approximately 4 hours per injection
Total BG-AUC0-4 h
Approximately 4 hrs per injection
Minimal BG (BGmin, time to BGmin (tBGmin)
Approximately 4 hrs per injection
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORRegular insulin SC at -17 mins
2ACTIVE_COMPARATORRegular insulin ID at -17 mins
3ACTIVE_COMPARATORRegular insulin ID at -2 mins
4ACTIVE_COMPARATORInsulin lispro given SC at -2 mins
5EXPERIMENTALInsulin lispro given ID at -2 mins

Interventions

NameTypeDescription
Regular insulin (Humulin)DRUGInsulin will be given either subcutaneously or intra-dermally, and at two different times prior to the liquid meal (T zero). At -17 mins, regular insulin will be given either SC or ID. At -2 mins, regular insulin will be given ID; also insulin lispro will be given either SC or ID. Each patient will receive 1 injection on 5 different study days.
Insulin lispro (Humalog)DRUGInsulin will be given either subcutaneously or intra-dermally, and at two different times prior to the liquid meal (T zero). At -17 mins, regular insulin will be given either SC or ID. At -2 mins, regular insulin will be given ID; also insulin lispro will be given either SC or ID. Each patient will receive 1 injection on 5 different study days.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Type 1 diabetes for 1-15 years, on multiple daily injections (MDI) or insulin pump (CSII) in stable control with HbA1c \<= 9.0%. * Able to attend clinic for 5 different days Exclusion Criteria: * BMI \> 32 kg/m2 * Evidence of gastroparesis or impaired renal function or lipod...

Countries:Germany
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Frequently asked questions about Regular insulin

What is Regular insulin used for in Diabetes Mellitus, Type 1?

Regular insulin is used for the treatment of Diabetes Mellitus, Type 1. It is an investigational small molecule being studied for its ability to manage blood glucose levels in patients with this condition. The drug is currently in Phase 2 clinical development.

What does Regular insulin target?

Regular insulin is a form of insulin, which targets insulin receptors to help regulate glucose metabolism. It is being studied for its effects on blood glucose levels after eating in patients with Type 1 diabetes. The drug is administered via intradermal injection.

Who makes Regular insulin?

Regular insulin is being developed by Becton, Dickinson and Company, a company traded on the New York Stock Exchange under the ticker symbol BDX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Type 1 diabetes.

What phase is Regular insulin in?

Regular insulin is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for its potential use in managing blood glucose levels in patients with Type 1 diabetes.

What clinical trials is Regular insulin in?

Regular insulin has one completed clinical trial, identified as NCT00553488. This Phase 2 study, titled 'Feasibility Study of the Effect of Intra-Dermal Insulin Injection on Blood Glucose Levels After Eating,' enrolled 30 male participants aged 18 years and older in Germany. The trial was active-controlled and randomized.

Is Regular insulin the same as other insulin products?

Regular insulin is a specific formulation of insulin being developed by Becton, Dickinson and Company. It is administered via intradermal injection, which is a unique delivery method compared to traditional subcutaneous insulin. The drug is currently in Phase 2 trials for Type 1 diabetes.