Status:
TERMINATED
An Efficacy and Safety Study of Fixed-dose Rosiglitazone/Glimepiride to Treat Chinese Type 2 Diabetes Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 subje...
Detailed Description
The antihyperglycemic effect of the thiazolidinedione (TZD) class of oral antidiabetic agents is due to their ability to increase insulin sensitivity at the cellular level, which in turn improves the ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT01453049
Start Date
April 1 2010
End Date
October 1 2010
Last Update
March 27 2012
Active Locations (12)
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1
GSK Investigational Site
Wuhan, Hubei, China, 430030
2
GSK Investigational Site
Suzhou, Jiangsu, China, 215004
3
GSK Investigational Site
Dalian, Liaoning, China, 116027
4
GSK Investigational Site
Hangzhou, Zhejiang, China, 310003