Clinical trial NCT01789788: A Safety, Pharmacokinetics and Pharmacodynamics Study of RO6811135 in Patients With Type 2 Diabetes Mellitus
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-02-12
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: approximately 5 months
Secondary outcomes:
measure: Pharmacokinetics: Area under the concentration-time curve (AUC)
timeFrame: Day 1 and Day 14
measure: Pharmacodynamics of RO681135: Blood analysis
timeFrame: 14 days
Other outcomes:
Locations:
city: Chula Vista
country: United States
state: California
city: Cincinnati
country: United States
state: Ohio
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: