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

Phase 1

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: Placebo; Drug: RO6811135

• Registration Number: NCT01789788
• Lead Sponsor: Hoffmann-La Roche

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 available

Study Timeline

• Study First Submitted: 2013-02-08
• Study First Submitted QC: 2013-02-08
• Study First Posted: 2013-02-12
• Study Start: 2013-03
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
RO6811135	RO6811135	-

Primary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	approximately 5 months

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Area under the concentration-time curve (AUC)	Day 1 and Day 14
Pharmacodynamics of RO681135: Blood analysis	14 days