Combination therapy of Elecoglipron and Dapagliflozin in adults with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 3 study, adults with type 2 diabetes who are not adequately controlled with lifestyle changes or existing glucose-lowering medications will be randomized to receive Elecoglipron, Dapagliflozin, or their matched-placebo combinations. The goal is to evaluate the efficacy, safety, and tolerability of the combination versus the single agents. Key outcomes include changes in HbA1c and other safety measures over a defined treatment period. Eligible participants have stable weight, BMI ≥23, and HbA1c between 7% and 10.5%. Exclusion criteria include type 1 diabetes, significant GI conditions, and recent severe hypoglycemia. The study is sponsored by AstraZeneca with locations in Huntsville, Mobile, and Sheffield, Alabama.

Why it matters

Who can join: the full rules

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

Where it's running

• Research Site
  Little Rock, Arkansas, United States Recruiting
• Research Site
  Los Angeles, California, United States Recruiting
• Research Site
  Lake City, Florida, United States Recruiting
• Research Site
  Lakeland, Florida, United States Recruiting
• Research Site
  Chicago, Illinois, United States Recruiting
• Research Site
  Oxon Hill, Maryland, United States Recruiting

+253 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.