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AZD1656

Phase 2

Type 2 Diabetes | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Jun 20, 2024

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials8
Total Enrollment243

FDA Designations

No designations recorded

Clinical trial landscape

AZD1656 · 26 trials · 13 indications

Phase 2 5Phase 1 21
NCT05216172AZD1656 in Transplantation With Diabetes tO PromoTe Immune TOleraNceType 2 Diabetes
COMPLETED26 Analytics
NCT01152385Japan Dose Regimen Study of AZD1656 in Japanese Type 2 Diabetes Mellitus PatientsType 2 Diabetes Mellitus
COMPLETED224 Analytics
NCT01020123Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus (TD2M) PatientsType II Diabetes Mellitus
COMPLETED530 Analytics
NCT00856908Safety and Tolerability After Four Weeks of Treatment With AZD1656 in Patients With Type 2 DiabetesType II Diabetes
COMPLETED20 Analytics
NCT00817778Study to Assess the Safety and Tolerability After Multiple Oral Doses of AZD1656 in Patients With Type 2 Diabetes Mellitus Treated With MetforminType 2 Diabetes
COMPLETED27 Analytics
PHASE2COMPLETED
AZD1656 in Transplantation With Diabetes tO PromoTe Immune TOleraNce
Type 2 Diabetes
NCT0521617226
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PHASE2COMPLETED
Japan Dose Regimen Study of AZD1656 in Japanese Type 2 Diabetes Mellitus Patients
Type 2 Diabetes Mellitus
NCT01152385224
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PHASE2COMPLETED
Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus (TD2M) Patients
Type II Diabetes Mellitus
NCT01020123530
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PHASE2COMPLETED
Safety and Tolerability After Four Weeks of Treatment With AZD1656 in Patients With Type 2 Diabetes
Type II Diabetes
NCT0085690820
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PHASE2COMPLETED
Study to Assess the Safety and Tolerability After Multiple Oral Doses of AZD1656 in Patients With Type 2 Diabetes Mellitus Treated With Metformin
Type 2 Diabetes
NCT0081777827
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Study Endpoints

Primary Endpoints

peripheral regulatory T cells
14 weeks

Change in mean peripheral Treg cell number between baseline and 3 months measured using flow cytometry analysis (FACS) in AZD1656 and placebo arms

Change in Haemoglobin A1c (HbA1c)
from baseline to 4 months
HbA1c: Change From Baseline to 4 Month
Baseline to 4th Month

AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue

Systolic Blood Pressure, Change From Baseline to End of Treatment
Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period
Diastolic Blood Pressure, Change From Baseline to End of Treatment
Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period
Pulse, Change From Baseline to End of Treatment
Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period
Weight, Change From Baseline to End of Treatment
Baseline is the day before first dose, end of treatment is last day of treatment
Clinically Relevant Change of Laboratory Variables
Measured regularly from day before first dose to day after last dose

Number of participants with clinically relevant change of laboratory variables (clinical chemistry, haematology and urinalysis parameters

Primary Objective to assess the safety and tolerability of AZD1656, following oral administration of single ascending supratherapeutic doses of AZD1656 to patients with type 2 diabetes mellitus in a fasted state.
From screening until Follow up
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of AUC of AZD1656.
Blood samples will be collected from predose to 48 hrs at each treatment period 1
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of Cmax of AZD1656.
Blood samples will be collected from predose to 48 hrs at each treatment period 1
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of tmax of AZD1656.
Blood samples will be collected from predose to 48 hrs at each treatment period 1
evaluate the pharmacokinetics of digoxin after a single dose when administered alone and in combination with AZD1656 at steady state, by assessment of AUC and Cmax of digoxin
Serial PK blood samples will be taken on days 4-8 during the treatment periods
To evaluate the pharmacokinetics of warfarin after a single dose when administered alone and in combination with AZD1656 at steady state by assessment of AUC and Cmax of both enantiomers of warfarin (S- and R-warfarin).
Serial PK blood samples will be taken on days 4-10 during the treatment periods
To evaluate the effect of AZD1656 on the steady state pharmacokinetics of simvastatin (including simvastatin acid) and vice versa by assessment of AUC(0-24) and Cmax.
Frequent blood samples for PK analysis will be drawn during 24 hours post morning dose on day 4 in each treatment period (1-3)
To evaluate the effect of AZD1656 on the steady-state PK of sitagliptin and vice versa by assessment of AUC0-24 and Cmax
Serial PK sampling will be done on Days 5, 10 and 15
PK of AZD1656 when administered with placebo or following repeated dosing of gemfibrozil by assessment of AUC and Cmax.
Serial blood samples will be drawn on day 4-6 period 1 and 2 from pre-dose to 48 h post AZD1656 administration.
Change-from-baseline variables will be calculated for the safety variables listed below, as the post-treatment value minus the value at baseline
The baseline values will be as follows:
To evaluate the effect of AZD1656 on the steady state pharmacokinetics of Pioglitazone and vice versa by assessment of AUC (0-24) and Cmax.
Serial blood samples on Days 5, 10 and 15 to assess pharmacokinetics of Pioglitazon, the metabolite hydroxyl-Pioglitazone, AZD1656 and its metabolite as appropriate.
Safety variables (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG
AE will be collected from the time for randomisation until follow-up visit. Safety variables and vital signs will be measured at the pre-entry, during study days -2 to 10 and at the follow-up visit.
Total recovery of radioactive dose, rate and routes of excretion of total radioactivity, metabolic pattern and metabolic profile, and PK variables of AZD1656 (AUC, Cmax, tmax, t1/2, Total Ae, CL/F and CLR)
One blood sample for analysis of plasma concentrations of AZD1656 taken on several days during the treatment period. A full PK profile for AZD1656 will also be taken on the last day of treatment
Safety by assessment of adverse events, BP, pulse rate, plasma glucose, safety laboratory variables and ECG
Blood samples taken repeatedly during 24 hours on study day sessions
P-Glucose levels
Repeated sampling during the 24 hour period on day 5 and 8
24-hr glucose (Calculated plasma glucose AUC0-24, change in fasting plasma glucose)
Repeated sampling during the 24 hour period on day -1, 4 and 8
Pharmacokinetic variables ( Area under the plasma concentration vs. time curve (AUC), maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal elimination half-life (t½) and apparent oral clearance (CL/F)
Blood samples taken up to 72 hours
Pharmacodynamic variables
Blood samples taken repeatedly up to 6 hours during study days
Safety variables (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG)
Blood samples taken repeatedly during 24 hours on study day sessions
Safety variables (AE, BP, pulse, weight, plasma glucose, laboratory variables and ECG)
Blood samples taken repeatedly during 24 hours on study day sessions
Safety variables (AE, BP, pulse, plasma glucose, laboratory variables and ECG)
Blood samples taken repeatedly during 24 hours on study day sessions
Safety variables (AEs, blood pressure (BP), pulse, safety laboratory variables and electrocardiography (ECG)
Safety variables taken repeatedly during 24 hours on study day sessions
Safety variables (AE's, BP, pulse, lab variables, and ECG)
Safety variables taken repeatedly during 24 hours on study day sessions

Secondary Endpoints

regulatory T cells in renal transplant
3 months
delayed graft function
1 week
glycemic control: HbA1c
3 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD1656EXPERIMENTALAZD1656 100mg BD for 3 months
placeboPLACEBO_COMPARATORplacebo 100mg BD for 3 months
highEXPERIMENTALAZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
MiddleEXPERIMENTALAZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
lowEXPERIMENTALAZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
4PLACEBO_COMPARATOR -
1EXPERIMENTALAZD1656
2EXPERIMENTALAZD1656
3EXPERIMENTALAZD1656
5EXPERIMENTALAZD1656
6PLACEBO_COMPARATOR -
7ACTIVE_COMPARATORGlipizide administered to 1 group of patients
A - AZD1656EXPERIMENTALAZD1656
B - PlaceboPLACEBO_COMPARATORPlacebo
AEXPERIMENTAL3 gradually increasing repeated oral doses of AZD1656 given to 3 groups (6 on active substance in each group)
BPLACEBO_COMPARATORPlacebo oral suspension given to 3 groups (2 on placebo in each group)

Interventions

NameTypeDescription
AZD1656DRUGactive drug
PlaceboDRUGplacebo
GlipizideDRUGGlipizide administered to 1 group of patients
DigoxinDRUGOral tablet od on Day 4
WarfarinDRUGOral tablet od on Day 4
simvastatinDRUGOral tablet, single dose
SitagliptinDRUGOral tablet od
GemfibrozilDRUGOral tablet bid on day 1 - 5.
PioglitazoneDRUGTablet oral single dose for 10 days
GlucagonDRUG1 mg injected 3 hr post AZD1656 morning dose on day 5 alt. day 8
InsulinDRUGInsulin infusion given during 3 hours at one occasion.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:United KingdomJapanChileGermanyHungaryLatviaLithuaniaMexicoPeruPolandRomaniaSwedenUnited StatesIndia
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Competitive Landscape -Type 2 Diabetes 142 trials

Top 20 of 31 competitors

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY14PHASE3Retatrutide, Semaglutide
Amgen Inc.AMGN4PHASE3Maridebart cafraglutide
Novo Nordisk A/S Sponsored ADR Class BNVO19PHASE3Semaglutide
Pfizer Inc.PFE1PHASE3PF-08653944
ProKidney Corp. Class APROK1PHASE3Renal Autologous Cell Therapy
Oramed Pharmaceuticals IncorporatedORMP1PHASE3ORMD-0801
NewAmsterdam Pharma Company N.V.NAMS1PHASE3obicetrapib, ezetimibe daily
AstraZeneca PLCAZN3PHASE2AZD6234
Alnylam Pharmaceuticals, IncALNY2PHASE2ALN-4324
MediciNova, Inc.MNOV1PHASE2MN-001
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE1ARO-ALK7
MannKind CorporationMNKD1PHASE2Technosphere Insulin
Merck & Co., Inc.MRK1PHASE1MK-1403, additive coformulation
Insulet CorporationPODD5 - Undisclosed
Abbott LaboratoriesABT6N/AUndisclosed
Biomea Fusion IncBMEA2PHASE2icovamenib
Milestone Pharmaceuticals, Inc.MIST2PHASE2CX11
DexCom, Inc.DXCM6N/AUndisclosed
Design Therapeutics, Inc.DSGN1PHASE2Farxiga, Onglyza, Metformin Mix Treat type 2 diabetes, China Import
MiMedx Group, Inc.MDXG1N/AUndisclosed
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Frequently asked questions about AZD1656

What is AZD1656 used for?

AZD1656 is an investigational small molecule being studied for glucose lowering in Type 1 Diabetes, Type 2 Diabetes Mellitus, and healthy volunteers. It has been evaluated in Phase 1 clinical trials, all of which are completed, with a total enrollment of 611 participants across 9 studies.

Who makes AZD1656?

AZD1656 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is a small molecule in the metabolic therapeutic area, targeting glucose lowering for diabetes indications.

What phase is AZD1656 in?

AZD1656 is in Phase 1 clinical development. All 9 clinical trials for AZD1656 have been completed, with no active trials currently ongoing. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is AZD1656 in?

AZD1656 has completed several Phase 1 trials, including NCT00817505 evaluating tablet bioavailability in Type 1 Diabetes, NCT01083212 studying gemfibrozil effects on pharmacokinetics in Type 2 Diabetes Mellitus, NCT01103622 investigating digoxin interactions, and NCT01221519 assessing different tablet formulations in Type 2 Diabetes patients.

Is AZD1656 the same as any other drug?

AZD1656 is not known to have any alternative names. It is a distinct investigational compound developed by AstraZeneca, and no other names or aliases have been associated with this drug in clinical trial records.