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: September 22, 2014
Last verified: September 2014

February 8, 2013
September 22, 2014
March 2013
September 2013   (final data collection date for primary outcome measure)
Safety: Incidence of adverse events [ Time Frame: approximately 5 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01789788 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Safety, Pharmacokinetics and Pharmacodynamics Study of RO6811135 in Patients With Type 2 Diabetes Mellitus
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.

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Placebo
    Matching placebo, multiple doses
  • Drug: RO6811135
    multiple ascending doses
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: RO6811135
    Intervention: Drug: RO6811135
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01789788
BP28436
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP