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lixisenatide AVE0010

Phase 3

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Sanofi|Last Updated: Aug 4, 2015

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
CONTROLLEDBiomarker
Total Trials2
Total Enrollment655
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01960179Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 DiabetesPHASE3 COMPLETED 361 — — Nov 1, 2013Mar 1, 2015Apr 9, 201530 Japan
NCT01940965Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 DiabetesPHASE3 COMPLETED 294 — — Sep 1, 2013Jul 1, 2015Aug 4, 201527 Japan
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Study Endpoints
Primary Endpoints
Safety over 24 and 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data.
from baseline to 24 weeks and 52 weeks
Safety over 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data
52 weeks
Secondary Endpoints
Absolute change in HbA1c
from baseline to week 24 and week 52
Absolute change in fasting plasma glucose
from baseline to week 24 and week 52
Absolute change in body weight
from baseline to week 24 and week 52
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
lixisenatideEXPERIMENTALlixisenatide monotherapy by group (Group 1: 52-week treatment; Group 2: 24-week treatment)
Lixisenatide + BiguanideEXPERIMENTAL52-week treatment with Lixisenatide in combination with biguanide (usual maintenance dose in the label)
Lixisenatide + TZDEXPERIMENTAL52-week treatment with lixisenatide in combination with TZD (usual maintenance dose in the label)
Lixisenatide + alpha-GIEXPERIMENTAL52-week treatment with Lixisenatide in combination with alpha-GI (usual maintenance dose in the label)
Lixisenatide + GlinideEXPERIMENTAL52-week treatment with Lixisenatide in combination with glinide (usual maintenance dose in the label)
Interventions
NameTypeDescription
lixisenatide AVE0010DRUGPharmaceutical form:solution Route of administration: Subcutaneous injection
biguanideDRUGPharmaceutical form:tablet Route of administration: oral
TZDDRUGPharmaceutical form:tablet Route of administration: oral
alpha-GIDRUGPharmaceutical form:tablet Route of administration: oral
glinideDRUGPharmaceutical form:tablet Route of administration: oral
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites30

Inclusion criteria: * Patients with type 2 diabetes mellitus diagnosed for at least 2 months. * Not treated with anti-diabetic drug or treated with a stable dose of 1 oral anti-diabetic drug (OAD) for at least 3 months prior to screening visit. Previous OAD (if any) have to be stopped at Visit 1.1 ...

Countries:Japan
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