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AZD5658

Phase 1

Type 2 Diabetes | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Feb 2, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01176097To Assess Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and the Effect of Fasting After Single Oral Doses of AZD5658 in Type 2 DiabetesPHASE1 COMPLETED 24 — — Jul 1, 2010Feb 1, 2011Feb 2, 20121 United States
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Study Endpoints
Primary Endpoints
To investigate the safety and tolerability of AZD5658 following oral administration of single ascending doses and to estimate the maximum tolerated dose (MTD).
AEs-, blood pressure and pulse during study days. Safety labs - day -1 to day 4; ECG - days 1, 2 and 3
Secondary Endpoints
To investigate the pharmacokinetics of AZD5658 after single ascending oral doses in type 2 diabetes mellitus patients.
Venous blood samples for the determination of concentrations of AZD5658 in plasma will be taken predose and at various times up to 72 hours postdose
Pharmacodynamics (plasma glucose and serum insulin)
Plasma glucose and serum insulin determined on Day -1 through Day 4
Effect of fasting on the pharmacokinetics and explore the pharmacodynamics of AZD5658.
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
6 - 8 cohortsEXPERIMENTAL6 patients in each cohort will receive AZD5658
Interventions
NameTypeDescription
AZD5658DRUGoral suspension, escalating single doses
PlaceboDRUGoral suspension,single doses
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Eligibility Criteria
Age Range20 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients must be of non-childbearing potential. * Body mass index between greater than or equal to 19 and less than or equal to 40 kg/m2 * Patients with confirmed Type 2 Diabetes diagnosis for at least 1 year and treated with Metformin Exclusion Criteria: * Clinically signif...

Countries:United States
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Competitive Landscape -Type 2 Diabetes 151 trials
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