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A Multiple Ascending Dose Study of R1511 in Patients With Type 2 Diabetes Mellitus.

NCT ID: NCT00517465

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-03-31

Brief Summary

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This 4 arm study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of multiple ascending doses of R1511 compared to placebo in patients with type 2 diabetes mellitus. The starting dose of R1511 will be 100mg po bid for 5 1/2 days; this dose will be escalated in subsequent groups of patients to a potential maximum of 1200mg po bid for 5 1/2 days after a satisfactory assessment of blinded safety, tolerability, pharmacokinetic and pharmacodynamic data of the previous dose. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.

Detailed Description

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

RG1511

Intervention Type DRUG

Starting multiple doses of 100mg po bid escalated in subsequent groups of patients to potential maximum multiple dose of 1200mg po bid.

2

Group Type EXPERIMENTAL

RG1511

Intervention Type DRUG

Starting multiple doses of 100mg po bid escalated in subsequent groups of patients to potential maximum multiple dose of 1200mg po bid.

3

Group Type EXPERIMENTAL

RG1511

Intervention Type DRUG

Starting multiple doses of 100mg po bid escalated in subsequent groups of patients to potential maximum multiple dose of 1200mg po bid.

4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

po bid

Interventions

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Placebo

po bid

Intervention Type DRUG

RG1511

Starting multiple doses of 100mg po bid escalated in subsequent groups of patients to potential maximum multiple dose of 1200mg po bid.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Berlin, , Germany

Site Status

Neuss, , Germany

Site Status

Balatonfüred, , Hungary

Site Status

Budapest, , Hungary

Site Status

Bratislava, , Slovakia

Site Status

Bratislava, , Slovakia

Site Status

Slough, , United Kingdom

Site Status

Welwyn Garden City, , United Kingdom

Site Status

Countries

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Poland Germany Hungary Slovakia United Kingdom

Other Identifiers

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NP20945

Identifier Type: -

Identifier Source: org_study_id