Clinical Trials

Multiple completed Phase 1 clinical trials, sponsored entirely by AstraZeneca, have evaluated AZD1656 for therapeutic application in patients with type 2 diabetes mellitus, including those presenting with high blood sugar. Conducted using both monotherapy and concomitant metformin regimens, these investigations assessed the compound's safety, tolerability, pharmacokinetics, pharmacodynamics, and potential drug-drug interactions. Collectively, this body of research establishes the early safety and pharmacokinetic profiles of AZD1656 in type 2 diabetes research.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01221545 Completed
Type 2 Diabetes Mellitus
AstraZeneca
 2010-10 Phase 1
NCT01221519 Completed
Type 2 Diabetes Mellitus|High Blood Sugar
AstraZeneca
 2010-09 Phase 1
NCT01103622 Completed
Type 2 Diabetes Mellitus
AstraZeneca
 2010-06 Phase 1
NCT01103609 Completed
Type 2 Diabetes Mellitus
AstraZeneca
 2010-04 Phase 1
NCT01095991 Completed
Type 2 Diabetes Mellitus
AstraZeneca
 2010-03 Phase 1
NCT01096940 Completed
Type 2 Diabetes Mellitus
AstraZeneca
 2010-03 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the AZD1656 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD1656 selectively binds to and activates glucokinase in hepatocytes and pancreatic beta cells, accelerating the rate-limiting conversion of glucose to glucose-6-phosphate. This enzyme activation enhances glucose-stimulated insulin secretion and promotes hepatic glycogen synthesis, thereby lowering blood glucose levels to address the therapeutic requirements of type 2 diabetes mellitus.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.