A Safety, Pharmacokinetics and Pharmacodynamics Study of RO6811135 in Patients With Type 2 Diabetes Mellitus

Tracking Information
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; (submitted: February 8, 2013)	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; (submitted: February 8, 2013)	Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Day 1 and Day 14 ]; Pharmacodynamics of RO681135: Blood analysis [ Time Frame: 14 days ]
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
Condition ICMJE	Diabetes Mellitus Type 2
Intervention ICMJE	Drug: Placebo Matching placebo, multiple doses; Drug: RO6811135 multiple ascending doses
Study Arms	Placebo Comparator: Placebo Intervention: Drug: Placebo; Experimental: RO6811135 Intervention: Drug: RO6811135
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: August 19, 2013)	56
Original Estimated Enrollment ICMJE; (submitted: February 8, 2013)	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: Adult patients, 18 to 65 years of age, inclusive; Type 2 diabetes mellitus according to WHO criteria diagnosed for at least 3 months prior to screening; On stable dose of metformin for at least 2 months prior to screening; Fasting plasma glucose during the screening period </= 240 mg/dL; Hemoglobin A1c (HbA1c) levels at screening >/= 6.5% and </= 10.5%; Evidence of insulin secretory capacity at screening; Body mass index (BMI) 27 to 42 kg/m2, inclusive; Females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol Exclusion Criteria: Type 1 diabetes; Acquired or secondary forms of diabetes such as those resulting from pancreatic surgery/injury, cystic fibrosis related diabetes; History of acute metabolic complications such as diabetic ketoacidosis or state of hyperosmolar hyperglycemia; Evidence or history of clinically significant diabetic complications such as clinically severe diabetic peripheral neuropathy, clinically significant nephropathy as judged by the investigator, or pre-proliferative/proliferative diabetic retinopathy as judged by the investigator; History of severe symptomatic hypoglycemia (requiring assistances of a third party) within 6 months prior to screening; History or presence of clinically significant concomitant disease or disorder; Hemoglobin level below the lower limit of reference range at screening; Pregnant or lactating women; History of anaphylaxis or severe systemic hypersensitivity or allergic reactions
Sex/Gender	Sexes Eligible for Study: All
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	Study Director: Clinical Trials Hoffmann-La Roche
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