Recent Updates
Recently added Catalysts

E1 and G1

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
E1 and G1DRUG -
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about E1 and G1

What is E1 and G1 used for?

E1 and G1 is an investigational small molecule combination being developed for Type 1 Diabetes and Type 2 Diabetes. It is currently in Phase 1 clinical development and is not approved by the FDA. The combination has been studied in patients with both types of diabetes in early-stage trials.

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 company is conducting clinical trials to evaluate this combination therapy for the treatment of diabetes.

What phase is E1 and G1 in?

E1 and G1 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in Type 1 Diabetes and one in Type 2 Diabetes. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is E1 and G1 in?

E1 and G1 has completed two Phase 1 clinical trials. NCT00239148 studied repeated doses of E1 in combination with G1 in 20 patients with Type 1 Diabetes. NCT00239187 studied the same combination in 30 patients with Type 2 Diabetes. Both trials were conducted in the United States.

Is E1 and G1 the same as G1 alone?

E1 and G1 is a combination therapy that includes both E1 and G1 components. The clinical trials specifically evaluated the effects of E1 when given in combination with G1, rather than G1 alone. The development program focuses on this combined treatment approach for diabetes.