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RO6811135

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 Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

RO6811135 · 3 trials · 2 indications

Phase 1 3
NCT01802853A Bioavailability and Pharmacokinetic Study of Subcutaneous and Intravenous RO6811135 in Healthy VolunteersHealthy Volunteer
COMPLETED12 Analytics
NCT01789788A Safety, Pharmacokinetics and Pharmacodynamics Study of RO6811135 in Patients With Type 2 Diabetes MellitusDiabetes Mellitus Type 2
COMPLETED56 Analytics
NCT01676584A Study of Single Dose RO6811135 in Healthy VolunteersHealthy Volunteer
COMPLETED56 Analytics
PHASE1COMPLETED
A Bioavailability and Pharmacokinetic Study of Subcutaneous and Intravenous RO6811135 in Healthy Volunteers
Healthy Volunteer
NCT0180285312
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PHASE1COMPLETED
A Safety, Pharmacokinetics and Pharmacodynamics Study of RO6811135 in Patients With Type 2 Diabetes Mellitus
Diabetes Mellitus Type 2
NCT0178978856
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PHASE1COMPLETED
A Study of Single Dose RO6811135 in Healthy Volunteers
Healthy Volunteer
NCT0167658456
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Study Endpoints

Primary Endpoints

Absolute bioavailability of RO6811135 after subcutaneous administration: Area under the concentration-time curve (AUC)
48 hours
Safety: Incidence of adverse events
approximately 5 months

Secondary Endpoints

Safety: Incidence of adverse events
approximately 5 weeks
Pharmacodynamics: Fasting serum glucose/serum insulin
48 hours
Nausea scale: Visual analogue scale
48 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
A: RO6811135 s.c.EXPERIMENTAL -
B: RO6811135 i.v.ACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
RO6811135EXPERIMENTAL -

Interventions

NameTypeDescription
RO6811135DRUGSingle subcutaneous dose
PlaceboDRUGMatching placebo, multiple doses
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male healthy volunteers, 18-45 years of age inclusive * Healthy as determined by screening assessments * Body mass index (BMI) between 18-30 kg/m2 Exclusion Criteria: * Any clinically relevant history or the presence of respiratory, renal, hepatic, gastrointestinal, hematolo...

Countries:United KingdomUnited States
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Frequently asked questions about RO6811135

What is RO6811135 used for?

RO6811135 is an investigational small molecule being developed by Roche Holding AG for the treatment of Type 2 Diabetes Mellitus. It has also been studied in healthy volunteers to assess its safety, tolerability, and pharmacokinetics. The drug is in Phase 1 clinical development and is not yet approved.

Who makes RO6811135?

RO6811135 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company has sponsored multiple Phase 1 clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers and in patients with Type 2 Diabetes Mellitus.

What phase is RO6811135 in?

RO6811135 is in Phase 1 clinical development. All three trials listed for the drug are Phase 1 studies, and all have been completed. The drug remains investigational and has not received regulatory approval for any indication.

What clinical trials is RO6811135 in?

RO6811135 has been studied in three completed Phase 1 trials: NCT01676584, a single-dose study in healthy volunteers; NCT01789788, a safety, pharmacokinetics, and pharmacodynamics study in patients with Type 2 Diabetes Mellitus; and NCT01802853, a bioavailability and pharmacokinetic study of subcutaneous and intravenous dosing in healthy volunteers.

Is RO6811135 FDA approved?

RO6811135 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. All completed trials have been early-stage studies focused on safety, tolerability, and pharmacokinetics in healthy volunteers and patients with Type 2 Diabetes Mellitus.

What is the mechanism of action of RO6811135?

The molecular target and mechanism of action for RO6811135 have not been disclosed in the available clinical trial information. The drug is classified as a small molecule and is being investigated for its potential role in treating Type 2 Diabetes Mellitus.