Recruiting NCT07664553

A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus on Background Insulin

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, 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, Australia, Bulgaria, Canada, China +8
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 Compared With Placebo in Adults With Type 2 Diabetes Mellitus on Background Insulin (Eluminate-3)

Overview

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults with Type 2 Diabetes Mellitus (T2DM), treated with a background insulin and other background glucose-lowering medication(s)

Interventions

Drug Elecoglipron
Elecoglipron is administered orally once daily.
Drug Placebo
Placebo is administered orally once daily.

Primary outcome measures

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

Secondary outcome measures (11)

Achieved HbA1c < 7% (53 mmol/mol) at Week 40 [Time frame: Week 40]
Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 40 [Time frame: Week 40]
Percent change from baseline to Week 40 in body weight [Time frame: Baseline to Week 40]
Change from baseline to Week 40 in body weight (kg) [Time frame: Baseline to Week 40]
Change from baseline to Week 40 in Systolic blood pressure (SBP) [Time frame: Baseline to Week 40]
Change from baseline to Week 40 in fasting plasma glucose (FPG) [Time frame: Baseline to Week 40]
Achieved HbA1c < 7% (53 mmol/mol) at Week 40 without hypoglycemia (glucose < 54 mg/dL [3.0 mmol/L] or severe hypoglycemia) [Time frame: Baseline to Week 40]
Change from baseline to Week 40 in daily mean 7-point self-monitoring blood glucose (SMBG) [Time frame: Baseline to Week 40]
Change from baseline to Week 40 in diastolic blood pressure (DBP) [Time frame: Baseline to Week 40]
Change from baseline to Week 40 in total daily insulin dose (IU) [Time frame: Baseline to Week 40]
Discontinued insulin by Week 40 [Time frame: Baseline to Week 40]

Eligibility criteria

Inclusion criteria

Diagnosed with T2DM for at least 90 days prior to screening
Stable treatment with background insulin and other background glucose-lowering medication(s)
HbA1c value of ≥ 7% to ≤ 10.5%
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

T1DM, 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 (NYHA 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

Germany · 22 centers

Research Site — Amberg
Research Site — Bad Oeynhausen
Research Site — Berlin
Research Site — Bochum
Research Site — Brandenburg an der Havel
Research Site — Daaden
Research Site — Duisburg
Research Site — Eisenach
… and 14 more centers

United States · 17 centers

Research Site — Little Rock
Research Site — Sacramento
Research Site — Aurora
Research Site — DeLand
Research Site — Doral
Research Site — Ocoee
Research Site — Decatur
Research Site — Potomac
… and 9 more centers

China · 15 centers

Research Site — Changsha
Research Site — Changsha
Research Site — Hefei
Research Site — Hefei
Research Site — Huai'an
Research Site — Langfang
Research Site — Liangyugang
Research Site — Luoyang
… and 7 more centers

India · 12 centers