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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well elecoglipron and dapagliflozin work together compared with either drug alone. It also checks safety and side effects. It is for adults with type 2 diabetes that is not well controlled with lifestyle changes alone or while taking other blood sugar medicines.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You have had type 2 diabetes for at least 90 days before screening.
  • Your diabetes is not well controlled with lifestyle changes alone or while on stable treatment with other blood sugar medicines.
  • Your HbA1c, a measure of average blood sugar, is 7% to 10.5%.
  • Your body mass index (BMI), a measure based on height and weight, is at least 23 at screening.
  • Your weight has stayed stable for 90 days before screening.

Who can't join

  • You have type 1 diabetes or another form besides type 2, including one present from birth. You have had ketoacidosis (dangerous acid buildup from diabetes) or a coma linked to very high blood sugar.
  • You are getting or expect to get treatment for diabetes-related eye damage or swelling in the part of the eye used for sharp vision.
  • You had severe low blood sugar more than once in the past 180 days, or you have trouble noticing signs of low blood sugar.
  • You have a serious condition in the upper digestive tract, or regularly take medicine that changes how food moves through or leaves your stomach.
  • You have had pancreatitis, which is swelling of the pancreas.
  • You have severe heart failure, called New York Heart Association class IV.
  • You or someone in your family has had medullary thyroid cancer or multiple endocrine neoplasia type 2, a condition that causes tumors in hormone-making glands.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (40)

AL

AR

CA

FL

GA

IA

IL

IN

LA

MA

MD

MI

MS

NC

NE

NM

NY

OH

OK

TN

TX

UT

VA

WA

WV