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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Drug: Placebo
* Drug: RO6811135


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matching placebo, multiple doses<br>|
| Experimental: RO6811135<br> | Drug: RO6811135<br>* multiple ascending doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | approximately 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Area under the concentration-time curve (AUC) |  | Day 1 and Day 14 | 
| Pharmacodynamics of RO681135: Blood analysis |  | 14 days |