Last updated: 11/04/2018 05:17:36

A Study Of Rosiglitazone Plus Insulin To Treat Type 2 Diabetes Mellitus Patients

GSK study ID
AVD102209
See study documents
Clinicaltrials.gov ID
NCT00349427
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomized, Double-Blind, Placebo-Control, Clinical Evaluation of Insulin Plus Rosiglitazone Compared to Insulin Plus Placebo for 24 Weeks in Subjects with Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin
Trial description: This study is designed to demonstrate that addition of rosiglitazone (4mg) to insulin in Type 2 diabetes mellitus subjects who have not achieved glycemic goals on insulin injections alone is efficacious in terms of improving glycemic control.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

glycemic control at treatment 24-week measured by HbA1c (Glycosylated hemoglobin)

Timeframe: 24 weeks

Secondary outcomes:

glycemic control at treatment 24-week measured by fasting plasma glucose and daily insulin dose, proportion of subjects who reduce total daily insulin dose after treatment of 8, 16, and 24 weeks

Timeframe: 8, 16, and 24 weeks

Interventions:
  • Drug: Rosiglitazone 4 mg
    • Enrollment:
    256
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Type 2 Diabetes Mellitus
    Product
    rosiglitazone
    Collaborators
    Not applicable
    Study date(s)
    October 2005 to November 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 70 years
    Accepts healthy volunteers
    No
    • Inclusion:
    • Patients with type 2 Diabetes mellitus on a minimum dose of 30 units/day insulin monotherapy continuously for at least 8 weeks
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion:
    • Patients with type 2 Diabetes mellitus on a minimum dose of 30 units/day insulin monotherapy continuously for at least 8 weeks
    • If Patients are taking another oral antidiabetic agent may stop their oral agent and adjust their insulin dose properly over 8 weeks prior to screening if they are asked by doctor who considers him/her suitable for study in all other respects, and the HbA1c level>7.5%. Exclusion:
    • Fasting plasma glucose >13 mmol/L at screening
    • Ongoing edema or history of peripheral edema requiring pharmacological treatment within 12 months
    • Drug abuse
    • Women pregnant or lactating
    • Use any rosiglitazone like drug in 3 months
    • Use more than one oral antidiabetic agent in 2 months
    • Uncontrolled hypertension
    • Chronic heart failure
    • Anemia

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Beijing, China, 100029
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Shanghai, China, 200233
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Beijing, China, 100034
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Shanghai, China, 200032
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Beijing, China, 100853
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Xian, Shanxi, China, 710032
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 10 Results

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2006-23-11

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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