Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD1656 · 24 trials · 11 indications
Change in mean peripheral Treg cell number between baseline and 3 months measured using flow cytometry analysis (FACS) in AZD1656 and placebo arms
AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue
Number of participants with clinically relevant change of laboratory variables (clinical chemistry, haematology and urinalysis parameters
| Arm | Type | Description |
|---|---|---|
| AZD1656 | EXPERIMENTAL | AZD1656 100mg BD for 3 months |
| placebo | PLACEBO_COMPARATOR | placebo 100mg BD for 3 months |
| high | EXPERIMENTAL | AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose) |
| Middle | EXPERIMENTAL | AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose) |
| low | EXPERIMENTAL | AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose) |
| 4 | PLACEBO_COMPARATOR | - |
| 1 | EXPERIMENTAL | AZD1656 |
| 2 | EXPERIMENTAL | AZD1656 |
| 3 | EXPERIMENTAL | AZD1656 |
| 5 | EXPERIMENTAL | AZD1656 |
| 6 | PLACEBO_COMPARATOR | - |
| 7 | ACTIVE_COMPARATOR | Glipizide administered to 1 group of patients |
| A - AZD1656 | EXPERIMENTAL | AZD1656 |
| B - Placebo | PLACEBO_COMPARATOR | Placebo |
| A | EXPERIMENTAL | 3 gradually increasing repeated oral doses of AZD1656 given to 3 groups (6 on active substance in each group) |
| B | PLACEBO_COMPARATOR | Placebo oral suspension given to 3 groups (2 on placebo in each group) |
| Name | Type | Description |
|---|---|---|
| AZD1656 | DRUG | active drug |
| Placebo | DRUG | placebo |
| Glipizide | DRUG | Glipizide administered to 1 group of patients |
| Digoxin | DRUG | Oral tablet od on Day 4 |
| Warfarin | DRUG | Oral tablet od on Day 4 |
| simvastatin | DRUG | Oral tablet, single dose |
| Sitagliptin | DRUG | Oral tablet od |
| Gemfibrozil | DRUG | Oral tablet bid on day 1 - 5. |
| Pioglitazone | DRUG | Tablet oral single dose for 10 days |
| Glucagon | DRUG | 1 mg injected 3 hr post AZD1656 morning dose on day 5 alt. day 8 |
| Insulin | DRUG | Insulin infusion given during 3 hours at one occasion. |
Inclusion Criteria: 1. Females or males aged 18 years and above 2. Having undergone renal transplantation at the Royal London Hospital within the previous 24 hours 3. A pre-transplant diagnosis of Type 2 diabetes 4. Provision of written, informed consent prior to any study specific procedures 5. In...
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AZD1656 is an investigational small molecule developed by AstraZeneca PLC for glucose lowering in type 1 and type 2 diabetes. It has been studied in clinical trials in patients with type 2 diabetes mellitus and in kidney transplant recipients with diabetes. It is not described as an approved medicine.
AZD1656 targets glucokinase, also known as GCK. It acts as a glucokinase activator, a small molecule that activates the GCK enzyme. Glucokinase plays a central role in glucose sensing and insulin secretion, which is the basis for studying AZD1656 for glucose lowering in diabetes.
AZD1656 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor behind the clinical program studying the compound in diabetes and in transplant recipients with diabetes.
AZD1656 is in clinical development, with Phase 1 and Phase 2 trials completed. It is an investigational drug and is not described as FDA approved. Nine trials have been completed in total, and none are currently active.
Completed AZD1656 trials include NCT05216172 in kidney transplant recipients with type 2 diabetes, NCT01221545 and NCT01221519 in type 2 diabetes mellitus, and NCT01152385, a Phase 2 dose regimen study in Japanese patients with type 2 diabetes mellitus. Across the program, 611 participants were enrolled.