Type 2 Diabetes Mellitus study: Elecoglipron vs Dapagliflozin
Official title A Phase III Study to Investigate the Efficacy and Safety of the Combination of Elecoglipron and Dapagliflozin in Adults With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT07662109
What this study is testing
What is Elecoglipron?
An investigational oral medicine being studied as a potential treatment for type 2 diabetes mellitus.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how well the two drugs work together and how safe they are, compared with each drug taken alone.
- Who it's for
- Adults who have type 2 diabetes that is not well controlled by diet, exercise, or other glucose‑lowering medicines.
- What's involved
- Participants will be assigned to take the combination of elecoglipron and dapagliflozin, elecoglipron alone, or dapagliflozin alone, with regular check‑ups to monitor safety and how they feel.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Lake City, Florida, United States
- Lakeland, Florida, United States
- Chicago, Illinois, United States
- Oxon Hill, Maryland, United States
- Troy, Michigan, United States
- Ridgeland, Mississippi, United States
- Albuquerque, New Mexico, United States
- Brooklyn, New York, United States
- Maumee, Ohio, United States
- Kingsport, Tennessee, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Paris, Texas, United States
- Newport News, Virginia, United States
- Kingwood, West Virginia, United States
- Buenos Aires, Argentina
- Natal, Brazil
- Beijing, China
+ 87 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Little Rock, Arkansas, United States; Los Angeles, California, United States; Lake City, Florida, United States; Lakeland, Florida, United States; Chicago, Illinois, United States; Oxon Hill, Maryland, United States and 101 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.