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2000 Participants NeededMy employer runs this trial

Elecoglipron + Dapagliflozin for Type 2 Diabetes

(Eluminate-5 Trial)

Recruiting at 240 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
Must not be taking: Gastric motility drugs
Disqualifiers: Type 1 diabetes, Pancreatitis, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 and dapagliflozin in combination, compared with elecoglipron alone and dapagliflozin alone, 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 medicines. People with certain health conditions or risks may not be able to join.

Inclusion Criteria

HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
My type 2 diabetes is not well controlled with diet or current medication.
Body mass index (BMI) of ≥ 23 kg/m2 at screening
See 2 more

Exclusion Criteria

I or my family have a history of medullary thyroid cancer or MEN2.
I have had multiple severe low blood sugar episodes or do not notice low blood sugar symptoms.
I have a serious upper digestive condition or take medicine that affects my stomach's movement.
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 either elecoglipron and dapagliflozin in combination, elecoglipron alone, or dapagliflozin alone, 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 the effects and safety of taking both elecoglipron and dapagliflozin together versus each drug alone in people with type 2 diabetes. Participants are randomly assigned to different treatment groups.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Active Control

Group I: Elecoglipron dose level 2 + dapagliflozin-matched placeboExperimental Treatment2 Interventions
Group II: Elecoglipron dose level 2 + dapagliflozinExperimental Treatment2 Interventions
Group III: Elecoglipron dose level 1 + dapagliflozin-matched placeboExperimental Treatment2 Interventions
Group IV: Elecoglipron dose level 1 + dapagliflozinExperimental Treatment2 Interventions
Group V: Elecoglipron-matched placebo + dapagliflozinActive Control2 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

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