800 Participants NeededMy employer runs this trial

Elecoglipron + Dapagliflozin for Type 2 Diabetes

(Eluminate-1 Trial)

Recruiting at 123 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: AstraZeneca
Must be taking: Glucose-lowering medications
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron alone or in combination with dapagliflozin compared with placebo in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes whose blood sugar isn't well controlled by diet, exercise, or other diabetes medications. Participants should not have certain health conditions that could interfere with the study.

Inclusion Criteria

I have had Type 2 Diabetes for at least 90 days.
My type 2 diabetes is not well controlled with diet or current medication.
HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
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Exclusion Criteria

I or my family have had medullary thyroid cancer or MEN2.
I have type 1 or secondary diabetes, or a history of ketoacidosis or diabetic coma.
I am currently being treated for diabetic eye disease or macular swelling.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive elecoglipron alone or in combination with dapagliflozin, or placebo, administered orally once daily

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares a new drug called elecoglipron alone or combined with dapagliflozin against placebo (inactive treatment) to see how well they lower blood sugar in people with type 2 diabetes.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Elecoglipron dose level 2 + dapagliflozin-matched placeboExperimental Treatment2 Interventions
Group II: Elecoglipron dose level 1 + dapagliflozin-matched placeboExperimental Treatment2 Interventions
Group III: Elecoglipron (one of the studied dose levels) + dapagliflozinExperimental Treatment2 Interventions
Group IV: Elecoglipron-matched placebo + dapagliflozin-matched placeboPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology