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RO5027838

Phase 2

Diabetes Mellitus Type 2 | Small molecule | Metabolic |Roche Holding AG|Last Updated: Jul 28, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

Clinical trial landscape

RO5027838 · 1 trial · 1 indication

Phase 2 1
NCT00823680A Study of RO5093151 and RO5027838 in Patients With Type 2 Diabetes Mellitus on a Stable Dose of MetforminDiabetes Mellitus Type 2
COMPLETED110 Analytics
PHASE2COMPLETED
A Study of RO5093151 and RO5027838 in Patients With Type 2 Diabetes Mellitus on a Stable Dose of Metformin
Diabetes Mellitus Type 2
NCT00823680110
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Study Endpoints

Primary Endpoints

Absolute change in mean daily plasma glucose
From baseline to day 27

Secondary Endpoints

Fasting plasma glucose
Baseline, and weeks 1, 2, 3 and 4
Post-prandial glucose and insulin
Baseline, weeks 2 and 4
Insulin sensitivity, beta cell function, lipid profile, HbA1C
At baseline, and at planned visits up to week 4
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
RO5027838 200mgEXPERIMENTAL -
RO5027838 50mgEXPERIMENTAL -
RO5093151 10mgEXPERIMENTAL -
RO5093151 400mgEXPERIMENTAL -

Interventions

NameTypeDescription
PlaceboDRUGpo bid for 4 weeks
RO5027838DRUG200mg po qd for 4 weeks
RO5093151DRUG400mg po bid for 4 weeks
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Eligibility Criteria

Age Range35 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * adult patients, 35-65 years of age; * type 2 diabetes for \>=3 months; * treated for \>=3 months with stable dose of metformin \>=1.5g/day or maximum tolerated dose. Exclusion Criteria: * history of diabetic ketoacidosis; * currently or previously treated with insulin; * cur...

Countries:United StatesAustriaGermany
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Frequently asked questions about RO5027838

What is RO5027838 used for?

RO5027838 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is intended for use in patients with Type 2 Diabetes who are on a stable dose of metformin. The drug is currently in Phase 2 clinical development.

Who makes RO5027838?

RO5027838 is being developed by Roche Holding AG, a biopharmaceutical company traded on the OTC market under the ticker RHHBY. The drug is an investigational small molecule in Phase 2 clinical development for Type 2 Diabetes Mellitus.

What phase is RO5027838 in?

RO5027838 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of Type 2 Diabetes Mellitus in patients on a stable dose of metformin.

What clinical trials is RO5027838 in?

RO5027838 has been studied in one completed Phase 2 clinical trial, identified as NCT00823680. This trial enrolled 110 participants with Type 2 Diabetes Mellitus who were on a stable dose of metformin. The study was randomized, double-blind, and placebo-controlled, and was conducted in the United States, Austria, and Germany.

Is RO5027838 the same as RO5093151?

RO5027838 is not the same as RO5093151. Both drugs were studied together in a single clinical trial, NCT00823680, which evaluated the combination of RO5093151 and RO5027838 in patients with Type 2 Diabetes Mellitus on a stable dose of metformin. The trial was a Phase 2, randomized, double-blind, placebo-controlled study.