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GWP42004

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Jazz Pharmaceuticals plc|Last Updated: Dec 20, 2022

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment207
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02053272A Study of GWP42004 as Add on to Metformin in the Treatment of Participants With Type 2 DiabetesPHASE2 COMPLETED 207 — — Feb 1, 2014Feb 1, 2016Dec 20, 202225 Romania, United Kingdom
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Study Endpoints
Primary Endpoints
Change from baseline to the end of treatment in mean glycosylated haemoglobin A1c (HbA1c) level.
Baseline (Day 1) and End of treatment (Day 85)

At baseline and at the end of treatment, a fasting blood sample is taken for measurement of HbA1c levels. Values are calculated as a percentage of total haemoglobin. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement.

Secondary Endpoints
Change from baseline to the end of treatment in mean fasting plasma glucose concentration.
Baseline (Day 1) and End of treatment (Day 85)
Change from baseline to the end of treatment in mean serum glucose concentration two hours post glucose challenge (Oral Glucose Tolerance Test [OGTT])
Baseline (Day 1) and End of treatment (Day 85)
Change from baseline to the end of treatment in mean serum fructosamine concentration.
Baseline (Day 1) and End of treatment (Day 85)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
2 mg GWP42004 bidACTIVE_COMPARATORLicaps® size double zero (Size 00) hard gelatin capsules containing 2 mg GWP42004 dissolved in excipients Macrogolglycerol Ricinoleate and Oleoyl macrogol-6-glycerides. One capsule taken twice daily for 12 weeks.
5 mg GWP42004 bidACTIVE_COMPARATORLicaps® size double zero (Size 00) hard gelatin capsules containing 5 mg GWP42004 dissolved in excipients Macrogolglycerol Ricinoleate and Oleoyl macrogol-6-glycerides. One capsule taken twice daily for 12 weeks.
15 mg GWP42004 bidACTIVE_COMPARATORLicaps® size double zero (Size 00) hard gelatin capsules containing 15 mg GWP42004 dissolved in excipients Macrogolglycerol Ricinoleate and Oleoyl macrogol-6-glycerides. One capsule taken twice daily for 12 weeks.
PlaceboPLACEBO_COMPARATORLicaps® size double zero (Size 00) hard gelatin capsules containing excipients Macrogolglycerol Ricinoleate and Oleoyl macrogol-6-glycerides. One capsule taken twice daily for 12 weeks.
Interventions
NameTypeDescription
GWP42004DRUGThe total dose administered within any 24-hour interval will be two capsules (typically 12 hours apart).
PlaceboDRUGThe total dose administered within any 24-hour interval will be two capsules (typically 12 hours apart).
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study (see Section 15.2). * Male or female participants aged 18 years or above. * Clinically diagnosed with Type 2 diabetes. * Participants receiving oral metformin (≥1000 mg per day) as anti-dia...

Countries:RomaniaUnited Kingdom
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