Recent Updates
Recently added Catalysts

RO4876904

Phase 2

Diabetes Mellitus Type 2 | Small molecule | Metabolic |Roche Holding AG|Last Updated: Aug 5, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment289

FDA Designations

No designations recorded

Clinical trial landscape

RO4876904 · 1 trial · 1 indication

Phase 2 1
NCT00502710A Study of Dipeptidyl-peptidase IV (DPP-IV) RO4876904 in Patients With Type 2 Diabetes.Diabetes Mellitus Type 2
COMPLETED289 Analytics
PHASE2COMPLETED
A Study of Dipeptidyl-peptidase IV (DPP-IV) RO4876904 in Patients With Type 2 Diabetes.
Diabetes Mellitus Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Absolute change in hemoglobin A1c (HbA1c)
Week 12

Secondary Endpoints

Absolute change in fasting plasma glucose (FPG), HbA1c response rate, absolute/relative change in insulin sensitivity, beta cell function, lipid profile.
Week 12
Adverse events (AEs), vital signs, laboratory parameters.
Throughout study
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RO4876904 1EXPERIMENTALEscalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.
RO4876904 2EXPERIMENTALEscalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.
RO4876904 3EXPERIMENTALEscalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.
RO4876904 4EXPERIMENTALEscalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.
PlaceboPLACEBO_COMPARATORPlacebo po daily. Patients receiving metformin before the study will continue on the same dose of metformin.

Interventions

NameTypeDescription
PlaceboDRUGPlacebo po daily.
RO4876904DRUGEscalating doses, at a starting dose of 12.5mg po daily.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites48

Inclusion Criteria: * adult patients, 18-75 years of age; * type 2 diabetes diagnosed \>= 1 month before screening; * drug-naive, or pretreated with maximum tolerated dose (MTD) of metformin; * BMI 25-45kg/m2. Exclusion Criteria: * type 1 diabetes; * any anti-hyperglycemic medication other than m...

Countries:United StatesAustraliaBrazilGuatemalaHong KongMexicoRussiaSpainUnited Kingdom
Unlock Eligibility Criteria

Frequently asked questions about RO4876904

What is RO4876904 used for?

RO4876904 is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus. It is a dipeptidyl-peptidase IV (DPP-IV) inhibitor, a class of drugs that helps regulate blood sugar levels. The drug is currently in Phase 2 clinical development and is not yet approved for use.

What does RO4876904 target?

RO4876904 targets the enzyme dipeptidyl-peptidase IV (DPP-IV). By inhibiting DPP-IV, the drug is designed to help manage blood glucose levels in patients with Type 2 Diabetes Mellitus. This mechanism is common in a class of diabetes medications known as gliptins.

Who makes RO4876904?

RO4876904 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market. The drug is currently in Phase 2 clinical trials for Type 2 Diabetes Mellitus.

What phase is RO4876904 in?

RO4876904 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for the treatment of Type 2 Diabetes Mellitus, and its Phase 2 trial has been completed.

What clinical trials is RO4876904 in?

RO4876904 has one completed Phase 2 clinical trial registered as NCT00502710. This study, titled 'A Study of Dipeptidyl-peptidase IV (DPP-IV) RO4876904 in Patients With Type 2 Diabetes,' enrolled 289 participants across multiple countries including the United States, Australia, and the United Kingdom. The trial was randomized, double-blind, and placebo-controlled.

Is RO4876904 the same as DPP-IV inhibitors?

RO4876904 is a specific DPP-IV inhibitor, meaning it belongs to the class of drugs that inhibit the enzyme dipeptidyl-peptidase IV. It is not the same as other DPP-IV inhibitors; it is a unique investigational compound developed by Roche. Its mechanism of action is shared with other drugs in this class.