A Comparison of Atorvastatin and Glimepiride Fixed Dose Combination and Atorvastatin and Glimepiride Loose Combination in the Treatment of Patients With Type 2 Diabetes Mellitus
NCT01495013 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 427
Last updated 2016-11-21
Summary
The aim of this 20 week study is to show that glimepiride/atorvastatin fixed dose combination tablet is safe and as effective as atorvastatin + glimepiride combination taken as separate tablets, in improving glycaemic control (glycated haemoglobin, HbA1c) and cholesterol levels (Low-density lipoprotein, LDL) in diabetic subjects, who are inadequately controlled on a stable dose of metformin. Eight dose combinations will be included.
Conditions
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
1mg Glimepiride/10mg Atorvastatin FDC
1 tablet by mouth once a day
- DRUG
-
2mg Glimepiride/10mg Atorvastatin FDC
1 tablet by mouth once a day
- DRUG
-
3mg Glimepiride/10mg Atorvastatin FDC
1 tablet by mouth once a day
- DRUG
-
4mg Glimepiride/10mg Atorvastatin FDC
1 tablet by mouth once a day
- DRUG
-
1mg Glimepiride/20mg Atorvastatin FDC
1 tablet by mouth once a day
- DRUG
-
2mg Glimepiride/20mg Atorvastatin FDC
1 tablet by mouth once a day
- DRUG
-
3mg Glimepiride/20mg Atorvastatin FDC
1 tablet by mouth once a day
- DRUG
-
4mg Glimepiride/20mg Atorvastatin FDC
1 tablet by mouth once a day
- DRUG
-
1mg Glimepiride
1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
- DRUG
-
2mg Glimepiride
1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
- DRUG
-
3mg Glimepiride
1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
- DRUG
-
4mg Glimepiride
1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
- DRUG
-
10mg Atorvastatin
1 tablet of Atorvastatin and 1 tablet of Glimepiride co-administered once daily
- DRUG
-
20mg Atorvastatin
1 tablet of Atorvastatin and 1 tablet of Glimepiride co-administered once daily
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-12-31
- Primary Completion
- 2013-04-30
- Completion
- 2013-09-30
Countries
- Malaysia
- Mexico
- Philippines
- Russia
- South Korea
- Thailand
Study Locations
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