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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01789788
Recruitment Status : Completed
First Posted : February 12, 2013
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Placebo Drug: RO6811135 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : March 2013
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Matching placebo, multiple doses
Experimental: RO6811135 Drug: RO6811135
multiple ascending doses


Outcome Measures

Primary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: approximately 5 months ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Day 1 and Day 14 ]
  2. Pharmacodynamics of RO681135: Blood analysis [ Time Frame: 14 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01789788     History of Changes
Other Study ID Numbers: BP28436
First Posted: February 12, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

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