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RO5095932

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment154

FDA Designations

No designations recorded

Clinical trial landscape

RO5095932 · 2 trials · 1 indication

Phase 1 2
NCT01017302A Study With RO5095932 in Patients With Type 2 Diabetes on Stable Metformin Therapy.Diabetes Mellitus Type 2
COMPLETED32 Analytics
NCT00961909A Study of RO5095932 in Patients With Type 2 Diabetes MellitusDiabetes Mellitus Type 2
COMPLETED122 Analytics
PHASE1COMPLETED
A Study With RO5095932 in Patients With Type 2 Diabetes on Stable Metformin Therapy.
Diabetes Mellitus Type 2Unlock trial analytics
PHASE1COMPLETED
A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus
Diabetes Mellitus Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Safety and Tolerability of various doses of RO5095932
Weeks 1-4, 6, 8
Safety and tolerability: AEs, laboratory parameters, ECG, body weight, vital signs
monitored throughout study, with weekly ECG and 2x weekly to 2-weekly laboratory assessments on study treatment and at intervals during follow-up
Change in hemoglobin A1c (HbA1c)
from baseline to week 6

Secondary Endpoints

Safety and Tolerability of a single dose of RO5095932
Week 5, 6, 8
Pharmacokinetics: blood concentration
Weeks 1-4, 6, 8
Pharmacodynamics: glucose, insulin, C-peptide
Weeks 1-4, 6, 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
3EXPERIMENTAL -
4PLACEBO_COMPARATOR -
1activeEXPERIMENTAL -
1placeboPLACEBO_COMPARATOR -
2activeEXPERIMENTAL -
2placeboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PlaceboDRUGSubcutenaous once weekly for 4 weeks
RO5095932DRUGEscalating subcutaneous doses once weekly over a 4 weeks period
metforminDRUGstable dose
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Adult patients, 18-65 years of age * Diabetes mellitus, type 2 for at least 6 months before screening * On treatment with stable doses of metformin for at least 3 months before screening * BMI between \>/=25 and \</=39 Exclusion Criteria: * Type 1 diabetes * Pancreatitis * T...

Countries:United States
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Frequently asked questions about RO5095932

What is RO5095932 used for?

RO5095932 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities. The drug is being studied in patients with Type 2 diabetes, including those on stable metformin therapy.

Who makes RO5095932?

RO5095932 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Type 2 Diabetes Mellitus. As of now, the drug is in Phase 1 development and has not received regulatory approval.

What phase is RO5095932 in?

RO5095932 is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total of 154 participants enrolled. The drug is investigational and has not been approved by the FDA or any other regulatory body. It is being studied for the treatment of Type 2 Diabetes Mellitus.

What clinical trials is RO5095932 in?

RO5095932 has been studied in two completed Phase 1 clinical trials: NCT00961909, which enrolled 122 patients with Type 2 Diabetes Mellitus, and NCT01017302, which enrolled 32 patients with Type 2 diabetes on stable metformin therapy. Both trials were conducted in the United States and were randomized, double-blind, and placebo-controlled.

Is RO5095932 FDA approved?

RO5095932 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Type 2 Diabetes Mellitus. Two Phase 1 trials have been completed, but the drug has not yet progressed to later stages of development or received marketing authorization. It remains under investigation for safety and efficacy.