Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes
Brief summary
This is a Phase 2, randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of icovamenib in participants with Type 2 Diabetes who are not achieving glycemic targets despite antihyperglycemic medications.
Detailed description
This study is a 52-week, Phase 2 trial is designed to examine whether treatment with icovamenib in participants with T2D who are currently on standard-of-care antihyperglycemic medications (metformin, SGLT2 inhibitor, alogliptin, or sitagliptin) plus lifestyle management will result in a greater reduction in HbA1c than those therapies alone. The trial investigates participants who have been on a stable dose of their antihyperglycemic medication(s) for at least 3 months prior to screening whose HbA1c remains above the target established by the American Diabetes Association (ADA).
Interventions
DRUGicovamenib 100mg
icovamenib 100mg
DRUGPlacebo
Matching placebo
Sponsors
Biomea Fusion Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
The study uses a randomized, double-blind, placebo-controlled design with parallel assignment between 2 treatments. The trial begins with a Screening Period of up to 28 days. Eligible participants will be randomly assigned to 1 of 2 treatment arms using a 2:1 ratio (active to placebo). Starting on Day 1, participants will receive icovamenib 100 mg or placebo in addition to their currently prescribed antihyperglycemic medication(s). Treatment with icovamenib or placebo will last for 12 weeks. At Week 12, participants in each treatment arm will continue on their currently prescribed antihyperglycemic medication(s). The total duration of the trial is approximately 56 weeks (including screening and follow-up).
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Males or females, age ≥18 years and ≤75 years 2. Diagnosed with T2D 3. Have been treated with lifestyle management with 1 to 3 antihyperglycemic medications: metformin, SGLT2i, alogliptin, or sitagliptin with a stable dose for at least 3 months prior to screening (if participants are taking metformin they must be on a minimum stable dose of ≥500 mg/day) 4. Have HbA1c ≥7.5 and ≤10.5% 5. Have a BMI ≤32 kg/m2 6. Female participants of childbearing potential must have a negative pregnancy test, must be non-lactating, must be willing to have additional pregnancy tests during the study, and must agree to the sex and contraception requirements. 7. Willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests. Key
Exclusion criteria
1. Have type 1 diabetes mellitus or a secondary form of diabetes 2. Have a history of diabetic ketoacidosis or hyperosmolar coma in the 6 months prior to screening 3. Have positive GAD autoantibody result within 60 days prior to screening 4. Have a history of severe hypoglycemia (defined by the occurrence of hypoglycemia symptoms requiring the assistance of another person for recovery) in the 6 months prior to screening or a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms as judged by the investigator 5. Have personal or family history (first-degree relative) of MEN1 6. Use of GLP-1 RA, dual GIP/GLP-1 RA, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, \[linagliptin, saxagliptin (these 2 are drugs within DPP-4i class)\], bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin in the 3 months prior to screening 7. Have fasting triglyceride ≥500 mg/dL 8. Have an eGFR \<60 mL/min/1.73 m2 by the CKD-EPI Creatinine Equation at screening 9. Have impaired liver function, defined as screening AST or ALT \>1.2×ULN, and/or total bilirubin \>ULN
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control | 26 weeks | Mean change in HbA1c from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control | 12 weeks | Mean change in HbA1c from baseline |
| To compare the change in fasting plasma glucose with icovamenib versus placebo during the off-treatment Follow-up Period | 26 weeks | Mean change in fasting plasma glucose from baseline |
| To compare the safety and tolerability of icovamenib versus placebo | 52 weeks | Incidence of AEs |
Countries
United States
Outcome results
None listed