Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron compared with oral semaglutide in adults with T2DM and increased cardiovascular risk that is inadequately managed alone or on stable treatment with other background glucose-lowering medication(s).
Interventions
DRUGElecoglipron
Elecoglipron is administered orally once daily.
DRUGSemaglutide
Semaglutide is administered orally once daily.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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(s) * HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol) * Increased risk of cardiovascular (CV) events defined by ≥1 of: documented coronary heart disease, peripheral arterial disease, ischemic cerebrovascular disease, or heart failure (NYHA II-III); or ≥2 CV risk factors * 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 Mellitus (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 Gastrointestinal (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 (NYHA IV) * History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Hemoglobin A1c (HbA1c) | Baseline to Week 52 |
Secondary
| Measure | Time frame |
|---|---|
| Percent change from baseline to Week 52 in body weight | Baseline to Week 52 |
| Change from baseline to Week 52 in body weight (kg) | Baseline to Week 52 |
| Achieved ≥ 5% weight loss from baseline at Week 52 and achieved HbA1c < 7% (53 mmol/mol) at Week 52 | Baseline to Week 52 |
| Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 52 | Week 52 |
| Achieved HbA1c < 7% (53 mmol/mol) at Week 52 | Week 52 |
| Achieved ≥ 5% weight loss from baseline at Week 52 | Baseline to Week 52 |
| Change from baseline to Week 52 in Systolic Blood Pressure (BP) and Diastolic BP | Baseline to Week 52 |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, China, Germany, Hungary, Italy, Japan, Poland, South Korea, Taiwan, United Kingdom, United States
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed