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Sitagliptin

Phase 3

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Sanofi|Last Updated: Oct 4, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment112
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00851903Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension TrialPHASE3 COMPLETED 112 — — Jun 1, 2009Sep 1, 2011Oct 4, 201216 United States, Austria +14
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Study Endpoints
Primary Endpoints
HbA1c Response Rate: Percentage of Patients Achieving Glycosylated Haemoglobin A1c (HbA1c) < 7% at Study Endpoint (End of Treatment Period)
study endpoint: week 12 or earlier in case of premature discontinuation
Secondary Endpoints
HbA1c: Change From Baseline to Study Endpoint
baseline, study endpoint: week 12 or earlier in case of premature discontinuation
Self-Monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint
baseline, study endpoint: week 12 or week 8 if value not available at week 12
7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint
baseline, study endpoint: week 12 or week 8 if value not available at week 12
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Combination insulin glargine and sitagliptinEXPERIMENTALInsulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 \< Fasting Plasma Glucose (FPG) ≤ 100 mg/dL (3.9 \<FPG ≤ 5.5 mmol/L). Sitagliptin: stable dose of 100 mg once a day administered with or without food.
Interventions
NameTypeDescription
Insulin GlargineDRUGSubcutaneous injection. 100 Units/mL solution for injection in a prefilled SoloStar® pen (3 mL).
SitagliptinDRUGOral administration. 100mg film-coated tablets.
MetforminDRUGPatients continued with metformin as usual oral anti-diabetic treatment.
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Eligibility Criteria
Age Range35 Years — 71 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion criteria: * Patients who completed the core study LANTU\_C\_02761 (NCT00751114) i.e. went through the visit 14 investigation, * HbA1c \>= 7 %, * Dose of metformin compliant with the inclusion criteria of the core study (i.e. at least 1 g/day), and maintained stable for the duration of the...

Countries:United StatesAustriaBrazilColombiaEgyptGreeceHong KongIndiaIsraelLebanonMexicoNetherlandsPortugalSouth KoreaSpainUnited Kingdom
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