Study of RO6807952 in Patients With Diabetes Mellitus Type 2

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01516476
First received: January 12, 2012
Last updated: July 7, 2014
Last verified: July 2014

January 12, 2012
July 7, 2014
November 2011
January 2012   (final data collection date for primary outcome measure)
Change in hemoglobin A1c (HA1c) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01516476 on ClinicalTrials.gov Archive Site
  • Change in fasting plasma glucose [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Safety (incidence of adverse events) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of RO6807952 in Patients With Diabetes Mellitus Type 2
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of RO6807952 in Type 2 Diabetic Patients Inadequately Controlled With Metformin Alone

This randomized, double-blind, placebo-controlled, multi-center study will evalu ate the efficacy and safety of RO6807952 in patients with diabetes mellitus type 2 inadequately controlled with metformin alone. Patients will be randomized to receive doses of RO6807952, placebo, or liraglutide. The anticipated time on stu dy treatment is 12 weeks.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: RO6807952
    multiple doses for 12 weeks
  • Drug: Placebo
    Placebo for 12 weeks
  • Drug: liraglutide
    liraglutide for 12 weeks
  • Experimental: RO6807952 Arm 1
    Intervention: Drug: RO6807952
  • Experimental: RO6807952 Arm 2
    Intervention: Drug: RO6807952
  • Placebo Comparator: Placebo Arm
    Intervention: Drug: Placebo
  • Experimental: Liraglutide Arm
    Intervention: Drug: liraglutide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients >/= 18 and </=70 years of age
  • Diagnosis of diabetes mellitus, type 2 for at least 3 months
  • Treated with a stable dose of metformin
  • Hemoglobin A1c >/=7.0% and </=10.5% at screening
  • Fasting plasma glucose </=240 mg/dL at screening
  • Body mass index >/=27 kg/m2 and </=42 kg/m2 at screening
  • Willing and able to maintain existing diet and exercise habits throughout the study
  • C-peptide >1.5 ng/mL at screening

Exclusion Criteria:

  • History of significant liver or kidney disease
  • History of uncontrolled hypertension
  • History of significant cardiovascular disease
  • History of significant diabetic complications
  • History of significant gastrointestinal conditions
  • History of weight loss surgery or procedures involving the gastrointestinal tract
  • History of chronic or acute pancreatitis
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01516476
BP27804
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

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