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Study of RO6807952 in Patients With Diabetes Mellitus Type 2

NCT ID: NCT01516476

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-01-31

Brief Summary

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This randomized, double-blind, placebo-controlled, multi-center study will evaluate the efficacy and safety of RO6807952 in patients with diabetes mellitus type 2 inadequately controlled with metformin alone. Patients will be randomized to receive doses of RO6807952, placebo, or liraglutide. The anticipated time on study treatment is 12 weeks.

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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Liraglutide Arm

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

liraglutide for 12 weeks

Placebo Arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for 12 weeks

RO6807952 Arm 1

Group Type EXPERIMENTAL

RO6807952

Intervention Type DRUG

multiple doses for 12 weeks

RO6807952 Arm 2

Group Type EXPERIMENTAL

RO6807952

Intervention Type DRUG

multiple doses for 12 weeks

Interventions

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Placebo

Placebo for 12 weeks

Intervention Type DRUG

RO6807952

multiple doses for 12 weeks

Intervention Type DRUG

RO6807952

multiple doses for 12 weeks

Intervention Type DRUG

liraglutide

liraglutide for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients \>/= 18 and \</=70 years of age
* Diagnosis of diabetes mellitus, type 2 for at least 3 months
* Treated with a stable dose of metformin
* Hemoglobin A1c \>/=7.0% and \</=10.5% at screening
* Fasting plasma glucose \</=240 mg/dL at screening
* Body mass index \>/=27 kg/m2 and \</=42 kg/m2 at screening
* Willing and able to maintain existing diet and exercise habits throughout the study
* C-peptide \>1.5 ng/mL at screening

Exclusion Criteria

* History of significant liver or kidney disease
* History of uncontrolled hypertension
* History of significant cardiovascular disease
* History of significant diabetic complications
* History of significant gastrointestinal conditions
* History of weight loss surgery or procedures involving the gastrointestinal tract
* History of chronic or acute pancreatitis
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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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Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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BP27804

Identifier Type: -

Identifier Source: org_study_id