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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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)

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Elecoglipron
  • Placebo

Treatment groups

600 Participants
are divided into 3 treatment groups

Sponsors and collaborators