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Sitagliptin

Phase 3

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Johnson & Johnson|Last Updated: Jan 15, 2015

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment756

FDA Designations

No designations recorded

Clinical trial landscape

Sitagliptin · 1 trial · 1 indication

Phase 3 1
NCT01137812The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial)Diabetes Mellitus, Type 2
COMPLETED756 Analytics
PHASE3COMPLETED
The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial)
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Change in HbA1c From Baseline to Week 52
Day 1 (Baseline) and Week 52

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.

Secondary Endpoints

Percentage of Patients With HbA1c <7% at Week 52
Week 52
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52
Day 1 (Baseline) and Week 52
Percent Change in Body Weight From Baseline to Week 52
Day 1 (Baseline) and Week 52
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Canagliflozin 300 mgEXPERIMENTALEach patient will receive 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea
Sitagliptin 100 mgACTIVE_COMPARATOREach patient will receive 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea

Interventions

NameTypeDescription
Sitagliptin 100 mgDRUGOne 100 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea
Canagliflozin 300 mgDRUGOne 300 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea
MetforminDRUGPatients will continue to take background therapy with Metformin for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of the study.
SulphonylureaDRUGPatients will continue to take background therapy with Sulphonylurea for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of the study.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites184

Inclusion Criteria: * All patients must have a diagnosis of T2DM and be currently treated with metformin and sulphonylurea * Patients in the study must have a HbA1c between \>=7 and \<=10.5% and a fasting plasma glucose (FPG) \<300 mg/dL (16.7 mmol/L) Exclusion Criteria: * History of diabetic ket...

Countries:United StatesAustriaBelgiumBrazilCanadaDenmarkFranceGermanyIndiaIsraelMalaysiaNetherlandsNew ZealandPolandSingaporeSouth KoreaUkraine
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Frequently asked questions about Sitagliptin

What is Sitagliptin used for?

Sitagliptin is used for the treatment of Diabetes Mellitus, Type 2. It is a small molecule being developed by Johnson & Johnson for this metabolic condition. The drug is currently in Phase 3 clinical development, meaning it is investigational and not yet approved for use.

What does Sitagliptin target?

Sitagliptin is a small molecule being studied for the treatment of Type 2 Diabetes Mellitus. Its specific molecular target has not been disclosed in the available information. The drug is currently in Phase 3 clinical trials, indicating it is still under investigation.

Who makes Sitagliptin?

Sitagliptin is being developed by Johnson & Johnson, a company traded on the stock exchange under the ticker JNJ. The drug is a small molecule intended for the treatment of Type 2 Diabetes Mellitus and is currently in Phase 3 clinical development.

What phase is Sitagliptin in?

Sitagliptin is in Phase 3 clinical development. It is an investigational drug for the treatment of Type 2 Diabetes Mellitus and has not yet been approved by regulatory authorities. The drug is being developed by Johnson & Johnson.

What clinical trials is Sitagliptin in?

Sitagliptin has been studied in a Phase 3 clinical trial with the identifier NCT01137812, titled 'The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial)'. This trial, which has been completed, enrolled 756 participants with Type 2 Diabetes Mellitus.

Is Sitagliptin the same as canagliflozin?

No, Sitagliptin is not the same as canagliflozin. The clinical trial NCT01137812, which studied Sitagliptin, was a comparator trial that included canagliflozin as an active control. Sitagliptin is a separate drug being developed by Johnson & Johnson for Type 2 Diabetes Mellitus.