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Sitagliptin

Phase 3

Diabetes Mellitus Type 2 | Small molecule | Metabolic |Roche Holding AG|Last Updated: Nov 4, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment666

FDA Designations

No designations recorded

Clinical trial landscape

Sitagliptin · 1 trial · 1 indication

Phase 3 1
NCT00754988A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.Diabetes Mellitus Type 2
COMPLETED666 Analytics
PHASE3COMPLETED
A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.
Diabetes Mellitus Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Mean changes in HbA1c
24 weeks

Secondary Endpoints

Change from baseline in fasting plasma glucose; change from baseline in body weight; responder rates for HbA1c (target <=7.0%, <=6.5%); responder rates for body weight; change from baseline in lipid profile; beta cell function.
24 weeks
Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.
Throughout study
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOROnce daily oral administration of placebo (matching sitagliptin). Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses.
SitagliptinACTIVE_COMPARATOROnce daily oral administration of 100 mg of sitagliptin. Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses.
Taspoglutide 10 mgEXPERIMENTALOnce weekly subcutaneous (sc) injection of 10 mg of taspoglutide. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses.
Taspoglutide up-titrated to 20 mgEXPERIMENTALOnce weekly sc injection of 10 mg of taspoglutide for the first 4 weeks, then up-titrated to once weekly sc injection of 20 mg of taspoglutide from week 5 onwards. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses.

Interventions

NameTypeDescription
MetforminDRUGAs prescribed
Placebo (matching sitagliptin)DRUGOnce daily oral administration of placebo (matching sitagliptin).
Placebo (matching taspoglutide)DRUGOnce weekly subcutaneous (sc) injection of placebo (matching taspoglutide).
SitagliptinDRUGOnce daily oral administration of 100 mg of sitagliptin.
TaspoglutideDRUGOnce weekly subcutaneous (sc) injection of 10 mg or 20 mg of taspoglutide.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites148

Inclusion Criteria: * adult patients, 18-75 years of age; * type 2 diabetes receiving metformin (\>=1500mg/day) for at least 12 weeks; * HbA1c \>=7.0% and \<=10.0% at screening; * BMI \>=25 (\>23 for Asians) and \<=45kg/m2 at screening; * stable weight +/- 5% for at least 12 weeks prior to screenin...

Countries:United StatesArgentinaAustraliaCanadaFranceGermanyGreeceMexicoNorwayPeruPolandPuerto RicoRomaniaSlovakiaSouth AfricaSouth KoreaSpainSwedenSwitzerlandTaiwanThailandTurkey (Türkiye)United Kingdom
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Frequently asked questions about Sitagliptin

What is Sitagliptin used for?

Sitagliptin is used for the treatment of Type 2 Diabetes Mellitus. It is being studied in patients whose condition is inadequately controlled with metformin. The drug is in Phase 3 clinical development and is being developed by Roche Holding AG.

What does Sitagliptin target?

Sitagliptin is a small molecule developed for Type 2 Diabetes Mellitus. Its specific molecular target is not disclosed in the available information. The drug is being evaluated in a Phase 3 clinical trial for its efficacy and safety in this patient population.

Who makes Sitagliptin?

Sitagliptin is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting a Phase 3 clinical trial of the drug for the treatment of Type 2 Diabetes Mellitus.

What phase is Sitagliptin in?

Sitagliptin is in Phase 3 clinical development. It is an investigational drug for Type 2 Diabetes Mellitus and has not been approved by regulatory authorities. The Phase 3 trial has been completed, with 666 participants enrolled.

What clinical trials is Sitagliptin in?

Sitagliptin has one completed Phase 3 clinical trial registered under NCT00754988. The study, titled "A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin," enrolled 666 participants across multiple countries.

Is Sitagliptin the same as Taspoglutide?

Sitagliptin is not the same as Taspoglutide. In the clinical trial NCT00754988, Taspoglutide is the investigational drug being compared against Sitagliptin as an active comparator. Sitagliptin is a separate drug developed by Roche Holding AG for Type 2 Diabetes Mellitus.