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RG1511

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 Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

RG1511 · 1 trial · 1 indication

Phase 1 1
NCT00517465A Multiple Ascending Dose Study of R1511 in Patients With Type 2 Diabetes Mellitus.Diabetes Mellitus Type 2
COMPLETED41 Analytics
PHASE1COMPLETED
A Multiple Ascending Dose Study of R1511 in Patients With Type 2 Diabetes Mellitus.
Diabetes Mellitus Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

AEs, laboratory parameters, vital signs.
Throughout study
Glucose AUC
Days -1, 1 and 8.

Secondary Endpoints

Insulin, C-peptide, glucagon and GLP-1 AUC
Days -1, 1 and 8
24h glucose
Days -1, 1 and 8
Lipid profiles
Days -1 and 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

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

Interventions

NameTypeDescription
PlaceboDRUGpo bid
RG1511DRUGStarting multiple doses of 100mg po bid escalated in subsequent groups of patients to potential maximum multiple dose of 1200mg po bid.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * adult patients, 18-65 years of age; * type 2 diabetic patients; * naive to anti-diabetic therapy, or taken off current anti-diabetic therapy for \>=2 weeks before first treatment. Exclusion Criteria: * type 1 diabetes mellitus; * clinically significant cardiovascular disease...

Countries:GermanyHungarySlovakiaUnited Kingdom
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Frequently asked questions about RG1511

What is RG1511 used for?

RG1511 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is in Phase 1 clinical development and has completed one trial in patients with this condition.

Who makes RG1511?

RG1511 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.

What phase is RG1511 in?

RG1511 is in Phase 1 clinical development. It has completed one Phase 1 trial, and the drug remains investigational, meaning it has not yet been approved for any use.

What clinical trials is RG1511 in?

RG1511 has one completed clinical trial, NCT00517465, titled 'A Multiple Ascending Dose Study of R1511 in Patients With Type 2 Diabetes Mellitus.' This Phase 1 study enrolled 41 participants and was conducted in Germany, Hungary, Slovakia, and the United Kingdom.

Is RG1511 the same as R1511?

Yes, RG1511 is also referred to as R1511 in clinical trial documentation. The completed study NCT00517465 uses the name R1511, indicating that both names refer to the same investigational drug.