Type 2 Diabetes Mellitus, Type 2 Diabetes With Chronic Kidney Disease
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) and impaired renal function, who are or will be on a background of sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin 10 mg as per guideline directed medical therapy (GDMT) for chronic kidney disease (CKD). Additionally, participants are on other glucose-lowering medication(s).
Interventions
DRUGElecoglipron
Elecoglipron is administered orally once daily.
DRUGPlacebo
Placebo 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 Type 2 Diabetes Mellitus for at least 90 days prior to screening * On SGTL2i or SGLT2i-naïve and other glucose lowering medication(s) * HbA1c value: 1. On stable dose of SGLT2i ≥ 7.0 % to ≤ 10.5% (53 to 91.3 mmol/mol) 2. SGLT2i-naive ≥ 7.5% to ≤ 10.5% (58 to 91.3 mmol/mol) * Impaired renal function * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Hemoglobin A1c (HbA1c) | Baseline to Week 40 |
Secondary
| Measure | Time frame |
|---|---|
| Achievement of HbA1c < 7% (53 mmol/mol) | Week 40 |
| Achievement of HbA1c ≤ 6.5% (48 mmol/mol) | Week 40 |
| Percent change in body weight | Baseline to Week 40 |
| Change from baseline in body weight | Baseline to Week 40 |
| Change from baseline in Systolic Blood Pressure (SBP) | Baseline to Week 40 |
| Achievement of HbA1c < 7% (53 mmol/mol) without hypoglycemia (glucose < 54 mg/dL (3.0 mmol/L) or severe hypoglycemia) | Baseline to Week 40 |
| Change from baseline in Fasting Plasma Glucose (FPG) | Baseline to Week 40 |
| Time to initiation of rescue medication over 40 weeks | Baseline to Week 40 |
| Change from baseline in Diastolic Blood Pressure (DBP) | Baseline to Week 40 |
Countries
Bulgaria, China, Denmark, Germany, India, Japan, Malaysia, Mexico, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States, Vietnam
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed