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E1 and G1

Phase 1

Type 1 Diabetes | Small molecule | Metabolic |Opko Health Inc.|Trials Updated: Oct 18, 2019

E1 and G1 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Oct 2005

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment50

FDA Designations

No designations recorded

E1 and G1 clinical trials

E1 and G1 · 2 trials · 2 indications

Phase 1 2
NCT00239187A Study in Type 2 Diabetic Patients With Repeated Doses of E1 in Combination With G1Type 2 Diabetes
COMPLETED30 Analytics
NCT00239148A Study in Type 1 Diabetic Patients With Repeated Doses of E1 in Combination With G1Type 1 Diabetes
COMPLETED20 Analytics
PHASE1COMPLETED
A Study in Type 2 Diabetic Patients With Repeated Doses of E1 in Combination With G1
Type 2 DiabetesUnlock trial analytics
PHASE1COMPLETED
A Study in Type 1 Diabetic Patients With Repeated Doses of E1 in Combination With G1
Type 1 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the safety and tolerability of repeated subcutaneous doses of E1 in combination with G1 in patients with type 2 diabetes
To evaluate the safety and tolerability of repeated subcutaneous doses of E1 in combination with G1 in patients with type 1 diabetes

Secondary Endpoints

To evaluate the pharmacokinetics (PK) profile and clinical effects of repeated subcutaneous doses of E1 in combination with G1 in patients with type 2 diabetes
To evaluate the pharmacokinetic (PK) profile and clinical effects of repeated subcutaneous doses of E1 in combination with G1 in patients with type 1 diabetes
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
E1 and G1DRUG -
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Eligibility Criteria

Age Range30 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Informed consent obtained from participants * Clinical diagnosis Type 2 diabetes requiring treatment with Metformin and/or TZD and who are otherwise healthy * On a stable Metformin and/or TZD regimen for at least 60 days prior to screening * Maximum stimulated c-peptide level ...

Countries:United States
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Frequently asked questions about E1 and G1

What is E1 and G1 used for?

E1 and G1 is an investigational small molecule combination being studied for the treatment of Type 1 Diabetes and Type 2 Diabetes. It is currently in Phase 1 clinical development and has not been approved by the FDA.

Who makes E1 and G1?

E1 and G1 is being developed by Opko Health Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol OPK. The combination is in Phase 1 clinical trials for diabetes.

What phase is E1 and G1 in?

E1 and G1 is in Phase 1 clinical development. It is an investigational drug combination and has not received FDA approval. Clinical trials for both Type 1 and Type 2 Diabetes have been completed.

What clinical trials is E1 and G1 in?

E1 and G1 has been studied in two completed Phase 1 clinical trials. One trial, NCT00239148, enrolled 20 patients with Type 1 Diabetes, and another, NCT00239187, enrolled 30 patients with Type 2 Diabetes. Both trials were conducted in the United States.

Is E1 and G1 the same as G1?

E1 and G1 is a combination therapy that includes two components, E1 and G1. Clinical trials have studied the effects of E1 when given in combination with G1 in patients with diabetes.