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

Roche

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus Type 2

Treatments

Drug: Placebo

Drug: RO6811135

Study type

Interventional

Funder types

Industry

Identifiers

NCT01789788

BP28436

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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