PHASE2 · Type 2 Diabetes · sponsored by Housey Healthcare ULC
Official title: HP-211 Safety and Proof of Concept Dose Ranging Study in Patients With Type 2 Diabetes Also covers: NCT07502508 — Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy Key Inclusion Criteria: * Have type 2 diabetes for greater than 3 months and no longer than 5 years by history prior to entering the trial, based upon ADA disease diagnostic criteria. * Have an HbA1c \> 6.5% and = 10% as determined by the central lab at Visit 1 (Screening). * Have been on a stable maximum dose of metformin for at least 3 months prior to entering the study or have been on stable therapy of diet and exercise only for at least 3 months. Stable treatment is defined as no change in treatment or dose in the last 3 months. Key Exclusion Criteria: * Have known type 1 diabetes. * Diabetic complications * Have taken any oral (other than metformin) or injectable treatment (insulin or GLP-1 RA classes or other) for type 2 diabetes currently or for greater than a 4 week duration previously. Previous treatment must have been stopped at least 3 months prior to screening * Systolic blood pressure greater than 150 mmHg or a diastolic blood pressure greater than 100 mmHg at Visit 1 on average after three supine measurements, or a known history of renal artery stenosis. * At baseline, the QT interval corrected by Fridericia (QTcF) ECG findings (\>450 msec for males and \>470 msec for females), left bundle branch block, or cardiac arrhythmia requiring medical or surgical treatment within 6 months prior to Visit 1 on the ECG.
What the clinic will ask you
Southwest General Healthcare Center's own pre-screening questions. You answer them when you apply — they go to the clinic only.
- Have you been diagnosed with type 2 diabetes?YesNoUnsure
- Do you have type 1 diabetes?NoYesUnsure
- Have you had diabetic complications like kidney disease, nerve damage, or eye problems from diabetes?UnsureYesNo
- In the last 6 months, have you had severe low blood sugar that required someone else to help you recover?YesNoUnsure
- Do you have a personal or family history of MEN1, MEN2, or medullary thyroid cancer?NoUnsureYes
- In the last 6 months, have you had diabetic ketoacidosis or a hyperosmolar coma?NoYesUnsure
