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: October 6, 2014
Last verified: October 2014
  Purpose

This randomized, double-blind, placebo-controlled, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics o f RO6811135 in patients with type 2 diabetes mellitus. Patients will be randomiz ed to receive either RO6811135 or placebo daily for 2 weeks, with a follow-up ex amination 2 to 3 weeks after the last dose of study drug.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo
Drug: RO6811135
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
Placebo Comparator: Placebo Drug: Placebo
Matching placebo, multiple doses
Experimental: RO6811135 Drug: RO6811135
multiple ascending 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 6, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014