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A Study of RO6811135 in Patients With Type 2 Diabetes Who Are Inadequately Controlled With Metformin

Primary Purpose

Diabetes Mellitus Type 2

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Placebo
RO6811135
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 - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults between the age of 18 and 65
  • Have been diagnosed with diabetes for at least 3 months and treated with a stable dose of metformin for at least 8 weeks
  • Hemoglobin A1c between 7.2 and 10.5%
  • Fasting plasma glucose less than 250 mg/dL
  • C-peptide greater than 1.5 ng/mL
  • Body mass index (BMI) between 27 and 44

Exclusion Criteria:

  • Pregnant or lactating women
  • Type 1 diabetes
  • Had undergone weight loss surgery or weight loss procedure involving the gastrointestinal tract, such as gastric bypass, gastric stapling, or gastric banding
  • Uncontrolled hypertension or other significant cardiovascular disease as determined by investigator
  • Significant kidney or liver disease as determined by the investigator

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    RO6811135

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change from baseline in HbA1c

    Secondary Outcome Measures

    Change from baseline in fasting plasma glucose (FPG)
    Pharmacokinetics: Area under the concentration-time curve (AUC)
    Safety: Incidence of adverse events

    Full Information

    First Posted
    September 23, 2013
    Last Updated
    November 1, 2016
    Sponsor
    Hoffmann-La Roche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01951183
    Brief Title
    A Study of RO6811135 in Patients With Type 2 Diabetes Who Are Inadequately Controlled With Metformin
    Official Title
    A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP, PHASE 2A STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-DAILY RO6811135 IN TYPE 2 DIABETIC PATIENTS INADEQUATELY CONTROLLED WITH METFORMIN
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Cancelled due to Sponsor's decision
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    December 2013 (Anticipated)
    Study Completion Date
    December 2013 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety and tolerability of RO6811135 in Type 2 diabetic patients treated with a stable dose of metformin.

    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
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Title
    RO6811135
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    RO681135 placebo subcutaneously daily
    Intervention Type
    Drug
    Intervention Name(s)
    RO6811135
    Intervention Description
    Subcutaneously daily
    Primary Outcome Measure Information:
    Title
    Change from baseline in HbA1c
    Time Frame
    from baseline to Week 12
    Secondary Outcome Measure Information:
    Title
    Change from baseline in fasting plasma glucose (FPG)
    Time Frame
    from baseline to Week 12
    Title
    Pharmacokinetics: Area under the concentration-time curve (AUC)
    Time Frame
    12 weeks
    Title
    Safety: Incidence of adverse events
    Time Frame
    19 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults between the age of 18 and 65 Have been diagnosed with diabetes for at least 3 months and treated with a stable dose of metformin for at least 8 weeks Hemoglobin A1c between 7.2 and 10.5% Fasting plasma glucose less than 250 mg/dL C-peptide greater than 1.5 ng/mL Body mass index (BMI) between 27 and 44 Exclusion Criteria: Pregnant or lactating women Type 1 diabetes Had undergone weight loss surgery or weight loss procedure involving the gastrointestinal tract, such as gastric bypass, gastric stapling, or gastric banding Uncontrolled hypertension or other significant cardiovascular disease as determined by investigator Significant kidney or liver disease as determined by the investigator
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clinical Trials
    Organizational Affiliation
    Hoffmann-La Roche
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study of RO6811135 in Patients With Type 2 Diabetes Who Are Inadequately Controlled With Metformin

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