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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01789788
First received: February 8, 2013
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: RO6811135
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: No ]
  • Pharmacodynamics of RO681135: Blood analysis [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: March 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RO6811135 Drug: RO6811135
multiple ascending doses
Placebo Comparator: Placebo Drug: Placebo
Matching placebo, multiple doses

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01789788

Locations
United States, California
Chula Vista, California, United States, 91911
United States, Ohio
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01789788     History of Changes
Other Study ID Numbers: BP28436
Study First Received: February 8, 2013
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 20, 2014