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sulfonylurea

Phase 3

Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Mar 8, 2017

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_CONTROLLED
Total Trials1
Total Enrollment264
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00395746Effect of Liraglutide in Combination With Sulfonylurea (SU) on Blood Glucose Control in Subjects With Type 2 DiabetesPHASE3 COMPLETED 264Oct 1, 2006May 1, 2008Mar 8, 20171 Japan
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Study Endpoints
Primary Endpoints
Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment
after 24 weeks of treatment
Secondary Endpoints
Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment
after 52 weeks of treatment
Fasting Plasma Glucose After 24 Weeks of Treatment
after 24 weeks of treatment
Fasting Plasma Glucose After 52 Weeks of Treatment
after 52 weeks of treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
0.6 mg + SUEXPERIMENTALLiraglutide 0.6 mg + sulphonylurea
0.9 mg + SUEXPERIMENTALLiraglutide 0.9 mg + sulphonylurea
SU Mono - 1PLACEBO_COMPARATORLiraglutide placebo 0.6 mg + sulphonylurea
SU Mono - 2PLACEBO_COMPARATORLiraglutide placebo 0.9 mg + sulphonylurea
Interventions
NameTypeDescription
sulfonylureaDRUGSU agent
liraglutideDRUGLiraglutide 0.6 mg/day or placebo. Injected s.c. (under the skin) once daily.
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Type 2 diabetes * Diet/exercise therapy with sulfonylurea (SU) for at least eight weeks * HbA1c greater than or equal to 7.0% and less than 10.0% * BMI less than 35 kg/m2 Exclusion Criteria: * Treatment with insulin within the last 12 weeks * Treatment with any drug that cou...

Countries:Japan
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