A Safety, Pharmacokinetics and Pharmacodynamics Study of RO6811135 in Patients With Type 2 Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT01789788 |
Recruitment Status
:
Completed
First Posted
: February 12, 2013
Last Update Posted
: November 2, 2016
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
Tracking Information | ||||
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First Submitted Date ICMJE | February 8, 2013 | |||
First Posted Date ICMJE | February 12, 2013 | |||
Last Update Posted Date | November 2, 2016 | |||
Study Start Date ICMJE | March 2013 | |||
Actual Primary Completion Date | September 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Safety: Incidence of adverse events [ Time Frame: approximately 5 months ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01789788 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Safety, Pharmacokinetics and Pharmacodynamics Study of RO6811135 in Patients With Type 2 Diabetes Mellitus | |||
Official Title ICMJE | A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO6811135 in Patients With Type 2 Diabetes Mellitus. | |||
Brief Summary | This randomized, double-blind, placebo-controlled, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in patients with type 2 diabetes mellitus. Patients will be randomized to receive either RO6811135 or placebo daily for 2 weeks, with a follow-up examination 2 to 3 weeks after the last dose of study drug. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Diabetes Mellitus Type 2 | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
56 | |||
Original Estimated Enrollment ICMJE |
60 | |||
Actual Study Completion Date | September 2013 | |||
Actual Primary Completion Date | September 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01789788 | |||
Other Study ID Numbers ICMJE | BP28436 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Hoffmann-La Roche | |||
Study Sponsor ICMJE | Hoffmann-La Roche | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Hoffmann-La Roche | |||
Verification Date | November 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |