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A Study With RO5095932 in Patients With Type 2 Diabetes on Stable Metformin Therapy.

NCT ID: NCT01017302

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-08-31

Brief Summary

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This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in adult patients with type 2 diabetes mellitus. Patients that are on stable metformin therapy are eligible to enter the study. There will be a 5-weeks exenatide run in period and a 5-weeks period when co-administered with the study drug. RO5095932 will be administered subcutaneously as a single dose or as escalating doses. Patients will be randomized to receive either active drug or placebo in weeks 1 to 4. Active drug or placebo will be administered once weekly for 4 weeks. Patients who received active drug in weeks 1 to 4 will receive placebo in week 5. Patients who received a single dose of placebo in weeks 1 to 4, will receive a single dose of active drug in week 5. The anticipated time of study treatment is \<6 months. The target sample size is \<100 patients.

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

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

RO5095932

Intervention Type DRUG

Escalating subcutaneous doses once weekly over a 4 weeks period

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutenaous once weekly for 4 weeks

3

Group Type EXPERIMENTAL

RO5095932

Intervention Type DRUG

Single subcutenaous dose in week 5

4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single subcutaneous dose in week 5

Interventions

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Placebo

Subcutenaous once weekly for 4 weeks

Intervention Type DRUG

Placebo

Single subcutaneous dose in week 5

Intervention Type DRUG

RO5095932

Escalating subcutaneous doses once weekly over a 4 weeks period

Intervention Type DRUG

RO5095932

Single subcutenaous dose in week 5

Intervention Type DRUG

Eligibility Criteria

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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
* Treatment with insulin for more than one week within 3 months prior to study start
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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San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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NP22709

Identifier Type: -

Identifier Source: org_study_id