No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
2,000 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
This trial is looking for adults with Type 2 Diabetes who have been managing their condition for at least three months but still need better control. They're particularly interested in those whose blood sugar levels are in a specific range and who have a body weight that meets certain guidelines. However, they’re not accepting people with certain serious health issues, like a history of severe low blood sugar or specific types of diabetes other than Type 2.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
State
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Status
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)
* …
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
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