Last updated: 11/03/2018 14:45:40

An efficacy and safety study of fixed-dose rosiglitazone/glimepiride to treat Chinese type 2 diabetes patients

GSK study ID
113263
See study documents
Clinicaltrials.gov ID
NCT01453049
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A multi-center, randomized, double-blind, parallel-group study to compare the efficacy and safety of fixed-dose Rosiglitazone/Glimepiride combination therapy with Glimepiride monotherapy for 24 weeks in drug naive subjects with type 2 diabetes
Trial description: The purpose of this study is to demonstrate that the rosiglitazone/glimepiride fixed-dose combination tablet will safely and effectively control glycemia as first-line oral therapy in drug naïve subjects with type 2 diabetes. This 24-week study will compare the effects of treatment with rosiglitazone/glimepiride to treatment with glimepiride alone. The primary objective is to demonstrate superiority of rosiglitazone/glimepiride to glimepiride in lowering Glycosylated Hemoglobin (HbA1c).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Change from Baseline in glycosylated hemoglobin (HbA1c) at Week 24

Timeframe: Baseline (Week 0) and Week 24

Secondary outcomes:

Change from Baseline in fasting plasma glucose (FPG) at Week 24

Timeframe: Baseline (Week 0) and Week 24

Number of HbA1c responders and non-responders

Timeframe: Baseline (Week 0) and Week 24 (LOCF)

Number of FPG responders and non-responders

Timeframe: Baseline (Week 0) and Week 24 (LOCF)

Number of participants who achieved HbA1c <7%, HbA1c <=6.5%, or who achieved a decrease of >=0.7% from Baseline

Timeframe: Baseline (Week 0) and Week 24 (LOCF)

Change from Baseline in fasting proinsulin and insulin at Week 24/Early withdrawal (EW)

Timeframe: Baseline (Week 0) and Week 24/EW

Change from Baseline in homeostasis model assessment sensitivity (HOMA-S) at Week 24/EW

Timeframe: Baseline (Week 0) and Week 24/EW

Change from Baseline in homeostasis model assessment beta-cell function (HOMA-B) at Week 24/EW

Timeframe: Baseline (Week 0) and Week 24/EW

Number of participants at various dose levels at Week 24/EW

Timeframe: Week 24/EW

Change from Baseline in total cholesterol (TC), high density lipoprotein-cholesterol (HDL-C), low density lipoprotein-cholesterol (LDL-C), and triglyceride (TG) at Week 24/EW

Timeframe: Baseline (Week 0) and Week 24/EW

Change from Baseline in blood urea nitrogen (BUN), sodium, potassium, chloride, calcium, and phosphorus at Week 24/EW

Timeframe: Baseline (Week 0) and Week 24/EW

Change from Baseline in the ratio of TC/HDL-C and LDL-C/HDL-C at Week 24/EW

Timeframe: Baseline (Week 0) and Week 24/EW

Change from Baseline in high sensitivity C-reactive protein (hs-CRP) at Week 24/EW

Timeframe: Baseline (Week 0) and Week 24/EW

Percent change from Baseline in high sensitivity C-reactive protein (hs-CRP) at Week 24/EW

Timeframe: Baseline (Week 0) and Week 24/EW

Change from Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 24/EW

Timeframe: Baseline (Week 0) and Week 24/EW

Change from Baseline in Adjusted Diabetes Quality of Life (A-DQOL) scores at Week 24/EW

Timeframe: Baseline (Week 0) and Week 24/EW

Number of participants with hypoglycemic events

Timeframe: Week 24/EW

Number of hypoglycemic events

Timeframe: Week 24/EW

Number of participants with a bone fracture

Timeframe: Week 24/EW

Change from Baseline in white blood cell (WBC) count and platelet count at Week 24/EW

Timeframe: Baseline (Week 0) and Week 24/EW

Change from Baseline in red blood cell (RBC) count at Week 24/EW

Timeframe: Baseline (Week 0) and Week 24/EW

Change from Baseline in lymphocytes, monocytes, neutrophils, eosinophils, and basophils at Week 24/EW

Timeframe: Baseline (Week 0) and Week 24/EW

Change from Baseline in hematocrit (HCT) at Week 24/EW

Timeframe: Baseline (Week 0) and Week 24/EW

Change from Baseline in hemoglobin (HE), mean corpuscular hemoglobin concentration (MCHC), total protein (TP), and albumin at Week 24/EW

Timeframe: Baseline (Week 0) and Week 24/EW

Change from Baseline in mean corpuscular volume (MCV) at Week 24/EW

Timeframe: Baseline (Week 0) and Week 24/EW

Change from Baseline in mean corpuscular hemoglobin (MCH) at Week 24/EW

Timeframe: Baseline (Week 0) and Week 24/EW

Change from Baseline in alanine transaminase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), lactate dehydrogenase (LDH), alkaline phosphatase (ALP), and creatine kinase (CK) at Week 24/EW

Timeframe: Baseline (Week 0) and Week 24/EW

Change from Baseline in total bilirubin (TB), direct bilirubin (DB), creatinine, and uric acid (UC) at Week 24/EW

Timeframe: Baseline (Week 0) and Week 24/EW

Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Week 24/EW

Timeframe: Baseline (Week 0) and Week 24/EW

Change from Baseline in heart rate at Week 24/EW

Timeframe: Baseline (Week 0) and Week 24/EW

Change from Baseline in weight at Week 24/EW

Timeframe: Baseline (Week 0) and Week 24/EW

Change from Baseline in electrocardiogram (ECG) assessment of heart rate at Week 24/EW

Timeframe: Baseline (Week 0) and Week 24/EW

Change from Baseline in electrocardiogram (ECG) data at Week 24/EW

Timeframe: Baseline (Week 0) and Week 24/EW

Interventions:
  • Drug: rosiglitazone/glimepiride fix dose combination
  • Drug: glimepiride
    • Enrollment:
    86
    Primary completion date:
    2010-31-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    glimepiride, rosiglitazone, rosiglitazone/glimepiride
    Collaborators
    Not applicable
    Study date(s)
    April 2010 to October 2010
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 75 years
    Accepts healthy volunteers
    No
    • type 2 diabetes mellitus
    • HbA1c between 7.5% and 11.0% at screening
    • Documented history of significant hypersensitivity to thiazolidinediones, sulfonylureas, or compounds with similar chemical structures
    • Ongoing edema or history of edema requiring pharmacological treatment in the 12 months prior to screening
    Inclusion and exclusion criteria
    Inclusion criteria:
    • type 2 diabetes mellitus
    • HbA1c between 7.5% and 11.0% at screening
    • FPG between 7.0mmol/L and 13.3mmol/L at screening and at randomization visit
    • subject was treated with diet and/or exercise alone
    • QTc<450mesc or QTc<480msec for patients with bundle branch block
    • Body Mass Index (BMI) >19kg/m2
    • Subject has given written informed consent
    Exclusion criteria:
    • Documented history of significant hypersensitivity to thiazolidinediones, sulfonylureas, or compounds with similar chemical structures
    • Ongoing edema or history of edema requiring pharmacological treatment in the 12 months prior to screening
    • Presence of ischemic heart disease and/or peripheral arterial disease, or NYHA grade I-IV congestive heart failure
    • Taking nitrates
    • Clinically significant renal or hepatic disease
    • Anemia
    • Severe hypertriglyceridemia (TG>=5.65mmol/L)
    • Use of oral corticosteroids and Nicotinic acid
    • Systolic blood pressure <170mmHg, or diastolic blood pressure > 100mmHg while on anti-hypertensive treatment
    • Hyperthyroidism requiring treatment
    • Diagnosed macular edema
    • Women who are lactating, pregnant, or planning to become pregnant
    • Presence of an active cancer or recently treated for cancer
    • Drug/alcohol abuse
    • Unwilling or unable to comply with the procedures described in the protocol

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Dalian, Liaoning, China, 116027
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Chongqing, China, 400016
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tianjin, China, 300052
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Wuhan, China, 430022
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Shenyang, China, 110003
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Beijing, China, 100730
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 12 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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Other
    Actual primary completion date
    2010-31-10
    Actual study completion date
    2010-31-10

    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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