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Study of RO6807952 in Patients With Diabetes Mellitus Type 2

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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Placebo Drug: RO6807952 Drug: liraglutide Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2011
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Liraglutide Arm Drug: liraglutide
liraglutide for 12 weeks
Placebo Comparator: Placebo Arm Drug: Placebo
Placebo for 12 weeks
Experimental: RO6807952 Arm 1 Drug: RO6807952
multiple doses for 12 weeks
Experimental: RO6807952 Arm 2 Drug: RO6807952
multiple doses for 12 weeks



Primary Outcome Measures :
  1. Change in hemoglobin A1c (HA1c) [ Time Frame: Baseline and 12 weeks ]

Secondary Outcome Measures :
  1. Change in fasting plasma glucose [ Time Frame: Baseline and 12 weeks ]
  2. Safety (incidence of adverse events) [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01516476


Locations
United States, Ohio
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01516476     History of Changes
Other Study ID Numbers: BP27804
First Posted: January 24, 2012    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
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists