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Study of RO6807952 in Patients With Diabetes Mellitus Type 2

Primary Purpose

Diabetes Mellitus Type 2

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
RO6807952
RO6807952
liraglutide
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Liraglutide Arm

Placebo Arm

RO6807952 Arm 1

RO6807952 Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Change in hemoglobin A1c (HA1c)

Secondary Outcome Measures

Change in fasting plasma glucose
Safety (incidence of adverse events)

Full Information

First Posted
January 12, 2012
Last Updated
November 1, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01516476
Brief Title
Study of RO6807952 in Patients With Diabetes Mellitus Type 2
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 Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide Arm
Arm Type
Experimental
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Title
RO6807952 Arm 1
Arm Type
Experimental
Arm Title
RO6807952 Arm 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for 12 weeks
Intervention Type
Drug
Intervention Name(s)
RO6807952
Intervention Description
multiple doses for 12 weeks
Intervention Type
Drug
Intervention Name(s)
RO6807952
Intervention Description
multiple doses for 12 weeks
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
liraglutide for 12 weeks
Primary Outcome Measure Information:
Title
Change in hemoglobin A1c (HA1c)
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change in fasting plasma glucose
Time Frame
Baseline and 12 weeks
Title
Safety (incidence of adverse events)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of RO6807952 in Patients With Diabetes Mellitus Type 2

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