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: October 20, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo
Drug: RO6807952
Drug: liraglutide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in hemoglobin A1c (HA1c) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2
Study Start Date: November 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516476

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01516476     History of Changes
Other Study ID Numbers: BP27804
Study First Received: January 12, 2012
Last Updated: October 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Liraglutide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014