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Dapagliflozin/Metformin

Phase 1

Healthy Volunteers | Small molecule | Other |AstraZeneca PLC|Last Updated: Jun 1, 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
RandomizedCONTROLLEDBiomarker
Total Trials2
Total Enrollment136
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01072578A Study to to Assess the Effect of Dapagliflozin When Administered Once a Day Versus Twice a Day on Blood GlucosePHASE1 COMPLETED 16 — — Feb 1, 2010Apr 1, 2010Jun 1, 20121 Germany
NCT01055691A Study Comparing the Amount of Metformin and After Taking a Combination Tablet vs. Separate TabletsPHASE1 COMPLETED 120 — — Jan 1, 2010Apr 1, 2010Jun 1, 20121 Germany
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Study Endpoints
Primary Endpoints
Calculation of derivation of pharmacokinetic variables
Up to 14 blood samples will be obtained on day 1 (with the closest interval between samples being 15 minutes), one sample on days 3 and 4, and up to 21 samples on day 5
bioequivalence will be demonstrated if the 90% confidence interval (CI) for the formulation effect is contained within the interval of 0.8000-1.2500 for AUC(0-t), AUCinf and Cmax with respect to both dapagliflozin and metformin.
Immediately prior to administration of the investigational product (IP). After intake of IP PK blood samples will be drawn every 15 minutes for the first hour, every 30 minutes for the second hour and every hour up to 72 h after intake of IP.
Secondary Endpoints
Calculation of derivation of pharmacodynamic variables (inhibition of plasma glucose re-absorption, 24 hour urine glucose excretion, inhibition of rate of gut glucose absorption by measuring plasma glucose, insulin and GIP).
plasma glucose will be drawn on Day 5, creatinine will be drawn at pre-dose of Day 4 and of Day 5, glucose and insulin will be drawn on Day 5 , Day 5 for GIP, urine will be collected on Day 5 in 4-hour intervals
To examine the safety and tolerability of the combination of dapagliflozin and metformin
Adverse events and laboratory variables assessed throughout both 5-day treatment periods, and a follow-up visit 5-10 days later
To examine the safety and tolerability of the combination of dapagliflozin and metformin.
Throughout study (for 4 days in each period and a follow-up visit ~6 days later)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTALFixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet
4EXPERIMENTALFree combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets
Interventions
NameTypeDescription
DapagliflozinDRUGDapagliflozin tablets 5 mg, Oral Twice daily dose for 5 days (total daily dose 10 mg)
Dapagliflozin/MetforminDRUGFixed dose combination dapagliflozin/metformin IR tablet 2.5 mg/850 mg Oral Single dose
MetforminDRUGmetformin IR tablet 850 mg Oral Single dose
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Female healthy volunteers must be post-menopausal (cessation of menses \>1year, be surgically sterile (documented) or have undergone hysterectomy) or be sexually abstinent from enrolment until follow-up examination * Have normal physical exam, vital signs ECG findings, and lab...

Countries:Germany
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