Type 2 Diabetes Mellitus
Conditions
Brief summary
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)
Interventions
DRUGPlacebo
Placebo is administered orally once daily.
DRUGElecoglipron
Elecoglipron is administered orally once daily.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Stable body weight (self-reported or documented) for 90 days prior to screening
Exclusion criteria
* 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 * 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 | Description |
|---|---|---|
| Change from baseline in Hemoglobin A1c (HbA1c) | Baseline to Week 40 | Summary statistics |
Secondary
| Measure | Time frame |
|---|---|
| Achieved HbA1c < 7% (53 mmol/mol) at Week 40 | Week 40 |
| Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 40 | Week 40 |
| Percent change from baseline to Week 40 in body weight | Baseline to Week 40 |
| Change from baseline to Week 40 in body weight (kg) | Baseline to Week 40 |
| Change from baseline to Week 40 in Systolic blood pressure (SBP) | Baseline to Week 40 |
| Change from baseline to Week 40 in fasting plasma glucose (FPG) | Baseline to Week 40 |
| Achieved HbA1c < 7% (53 mmol/mol) at Week 40 without hypoglycemia (glucose < 54 mg/dL [3.0 mmol/L] or severe hypoglycemia) | Baseline to Week 40 |
| Change from baseline to Week 40 in daily mean 7-point self-monitoring blood glucose (SMBG) | Baseline to Week 40 |
| Change from baseline to Week 40 in diastolic blood pressure (DBP) | Baseline to Week 40 |
| Change from baseline to Week 40 in total daily insulin dose (IU) | Baseline to Week 40 |
| Discontinued insulin by Week 40 | Baseline to Week 40 |
Countries
Australia, Bulgaria, Canada, China, Czechia, Germany, India, Japan, Malaysia, Poland, South Korea, Thailand, United States
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed