Back to resultsA Study of RO6807952 in Patients With Diabetes Mellitus Type 2
Primary Purpose
Diabetes Mellitus Type 2
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
RO6807952
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 2
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Safety: Incidence of adverse events
Secondary Outcome Measures
Blood concentrations of RO6807952
Effect of RO6807952 on Hemoglobin HbA1c level
Effect of RO6807952 on glucose level
Change in meal tolerance test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01358929
Brief Title
A Study of RO6807952 in Patients With Diabetes Mellitus Type 2
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to RO6807952
Intervention Type
Drug
Intervention Name(s)
RO6807952
Intervention Description
Escalating subcutaneous dose
Primary Outcome Measure Information:
Title
Safety: Incidence of adverse events
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Blood concentrations of RO6807952
Time Frame
8 weeks
Title
Effect of RO6807952 on Hemoglobin HbA1c level
Time Frame
8 weeks
Title
Effect of RO6807952 on glucose level
Time Frame
8 weeks
Title
Change in meal tolerance test
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
12. IPD Sharing Statement
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A Study of RO6807952 in Patients With Diabetes Mellitus Type 2
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