A Study of RO6807952 in Patients With Diabetes Mellitus Type 2
NCT ID: NCT01358929
Last Updated: 2016-11-02
Study Results
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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COMPLETED
PHASE1
45 participants
INTERVENTIONAL
2011-04-30
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
RO6807952
Escalating subcutaneous dose
2
Placebo
Placebo to RO6807952
Interventions
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Placebo
Placebo to RO6807952
RO6807952
Escalating subcutaneous dose
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of type 2 diabetes \>/=3 months and \</=10 years prior to screening
* Fasting plasma glucose \>/=110 mg/dL and \</=240 mg/dL
* Patients on a stable dose of metformin for at least 2 months prior to screening
* Hemoglobin HbA1c \>/=6.5% and \</=10.5%
* Body mass index \>/=25 kg/m2 and \</=42 kg/m2
* Systolic blood pressure \<155 mmHg and diastolic blood pressure \<95 mmHg
Exclusion Criteria
* History of significant renal and hepatic diseases
* History of metabolic acidosis and diabetic gastroparesis
* History of pancreatitis
* History of coagulation disorders or unexplained excessive bleeding
* History of clinically significant cardiovascular disease or severe symptomatic hypoglycemia within 6 months of screening
18 Years
70 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Chula Vista, California, United States
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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BP25742
Identifier Type: -
Identifier Source: org_study_id