Recent Updates
Recently added Catalysts

AZD1656

Phase 2

Type II Diabetes Mellitus | Unknown | Metabolic |AstraZeneca PLC|Last Updated: Nov 26, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials3
Total Enrollment611
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01020123Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus (TD2M) PatientsPHASE2 COMPLETED 530 — — Oct 1, 2009Feb 1, 2011Nov 26, 201277 Chile, Germany +9
NCT00995787Safety and Tolerability of AZD1656 in Type 2 Diabetes Mellitus (T2DM) Patients Treated With Metformin and SulfonylureaPHASE1 COMPLETED 75 — — Oct 1, 2009Feb 1, 2010Feb 26, 20101 United States
NCT00960791Study to Assess the Absorption, Distribution, Metabolism and Excretion of AZD1656 in Type 2 Diabetes Mellitus (T2DM)PHASE1 COMPLETED 6 — — Jul 1, 2009Sep 1, 2009Sep 16, 20092 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
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

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
Secondary Endpoints
FPG: to Evaluate Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.
baseline to 4 month
SMPG: Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.
baseline to 4 month
OGTT/Plasma Glucose
baseline to 4 month
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAZD1656
2EXPERIMENTALAZD1656
3EXPERIMENTALAZD1656
4EXPERIMENTALAZD1656
5EXPERIMENTALAZD1656
6PLACEBO_COMPARATOR -
7ACTIVE_COMPARATORGlipizide administered to 1 group of patients
AZD1656EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
AZD1656DRUGDifferent doses of AZD1656 administered to 5 groups of patients
PlaceboDRUGAZD1656 placebo and glipizide placebo administered to 1 group of patients
GlipizideDRUGGlipizide administered to 1 group of patients
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites77

Inclusion Criteria: * female of non-childbearing potential * Treated with maximally tolerated dose of metformin (≥ 1500mg/day) for at least 10 weeks prior to enrolment. * Patients with HbA1c ≥ 7.5 but ≤ 10% at enrolment visit (Visit 1) can enter cohort 1.Patients with HbA1c between \>10 % and \<12 ...

Countries:ChileGermanyHungaryLatviaLithuaniaMexicoPeruPolandRomaniaSwedenUnited KingdomUnited States
Unlock Eligibility Criteria