Study of RO6807952 in Patients With Diabetes Mellitus Type 2

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. Identifier: NCT01516476
Recruitment Status : Terminated
First Posted : January 24, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

January 12, 2012
January 24, 2012
November 2, 2016
November 2011
January 2012   (Final data collection date for primary outcome measure)
Change in hemoglobin A1c (HA1c) [ Time Frame: Baseline and 12 weeks ]
Same as current
Complete list of historical versions of study NCT01516476 on Archive Site
  • Change in fasting plasma glucose [ Time Frame: Baseline and 12 weeks ]
  • Safety (incidence of adverse events) [ Time Frame: 12 weeks ]
Same as current
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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 evaluate 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 study treatment is 12 weeks.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus Type 2
  • Drug: Placebo
    Placebo for 12 weeks
  • Drug: RO6807952
    multiple doses for 12 weeks
  • Drug: liraglutide
    liraglutide for 12 weeks
  • Experimental: Liraglutide Arm
    Intervention: Drug: liraglutide
  • Placebo Comparator: Placebo Arm
    Intervention: Drug: Placebo
  • Experimental: RO6807952 Arm 1
    Intervention: Drug: RO6807952
  • Experimental: RO6807952 Arm 2
    Intervention: Drug: RO6807952
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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