A Study of RO6807952 in Patients With Diabetes Mellitus Type 2
A Randomized, Placebo-Controlled, Sequential, Multiple-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MAR701/RO6807952 in Type 2 Diabetic Patients
1 other identifier
interventional
45
1 country
2
Brief Summary
This randomized, placebo-controlled, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6807952. Patients will receive multiple weekly subcutaneous doses of RO6870952. The anticipated time on study treatment is 8 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 diabetes-mellitus-type-2
Started Apr 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 18, 2011
CompletedFirst Posted
Study publicly available on registry
May 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedNovember 2, 2016
November 1, 2016
5 months
May 18, 2011
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Safety: Incidence of adverse events
8 weeks
Secondary Outcomes (4)
Blood concentrations of RO6807952
8 weeks
Effect of RO6807952 on Hemoglobin HbA1c level
8 weeks
Effect of RO6807952 on glucose level
8 weeks
Change in meal tolerance test
8 weeks
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Adult patients, 18 to 70 years of age, inclusive
- 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
You may not qualify if:
- Patients with type 1 diabetes
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Chula Vista, California, 91911, United States
Unknown Facility
Cincinnati, Ohio, 45227, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2011
First Posted
May 24, 2011
Study Start
April 1, 2011
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
November 2, 2016
Record last verified: 2016-11