Recruiting NCT07662109

A Phase III Study to Investigate the Efficacy and Safety of the Combination of Elecoglipron and Dapagliflozin in Adults With Type 2 Diabetes Mellitus

Phase III Interventional Type 2 Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Elecoglipron, Dapagliflozin, Elecoglipron-matched placebo, Dapagliflozin-matched placebo.
Who it may be relevant to: Registry conditions: Type 2 Diabetes Mellitus. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Brazil, China, Czechia +19
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-blind, Parallel-group Phase III Study 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 (Eluminate-5)

Overview

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.

Interventions

Drug Elecoglipron
Elecoglipron is administered orally once daily.
Drug Dapagliflozin
Dapagliflozin administered orally once daily.
Drug Elecoglipron-matched placebo
A placebo matching elecoglipron administered orally once daily.
Drug Dapagliflozin-matched placebo
A placebo matching dapagliflozin administered orally once daily.

Primary outcome measures

Change from baseline in Hemoglobin A1c (HbA1c) [Time frame: Baseline to Week 40]

Secondary outcome measures (10)

Change from baseline in Hemoglobin A1c (HbA1c) [Time frame: Baseline to Week 40]
Achievement of HbA1c < 7% (53 mmol/mol) [Time frame: Week 40]
Percent change in body weight [Time frame: Baseline to Week 40]
Change from baseline in body weight [Time frame: Baseline to Week 40]
Change from baseline in Fasting Plasma Glucose (FPG) [Time frame: Baseline to Week 40]
Change from baseline in daily mean 7-point Self-Monitored Blood Glucose (SMBG) [Time frame: Baseline to Week 40]
Achievement of ≥ 5% weight loss from baseline [Time frame: Baseline to Week 40]
Change from baseline in Systolic Blood Pressure (SBP) [Time frame: Baseline to Week 40]
Change from baseline in Diastolic Blood Pressure (DBP) [Time frame: Baseline to Week 40]
Time to initiation of rescue medication over 40 weeks [Time frame: Baseline to Week 40]

Eligibility criteria

Inclusion criteria

Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening
T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication
HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
Body mass index (BMI) of ≥ 23 kg/m2 at screening
Stable body weight (self-reported or documented) for 90 days prior to screening

Exclusion criteria

Type 1 Diabetes, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma
Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema
Have had more than one episode of severe hypoglycemia within 180 days prior to screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying
History of acute or chronic pancreatitis
Severe congestive heart failure (New York Heart Association IV)
History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

China · 48 centers

Research Site — Baotou
Research Site — Beijing
Research Site — Beijing
Research Site — Beijing
Research Site — Changde
Research Site — Changsha
Research Site — Changzhou
Research Site — Chengdu
… and 40 more centers

United States · 40 centers

Research Site — Huntsville
Research Site — Mobile
Research Site — Sheffield
Research Site — Little Rock
Research Site — Bakersfield
Research Site — Los Angeles
Research Site — Ontario
Research Site — Lake City
… and 32 more centers

India · 17 centers