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glimepiride

Phase 3

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |GSK plc|Last Updated: Nov 21, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment427

FDA Designations

No designations recorded

Clinical trial landscape

glimepiride · 1 trial · 1 indication

Phase 3 1
NCT01495013A Comparison of Atorvastatin and Glimepiride Fixed Dose Combination and Atorvastatin and Glimepiride Loose Combination in the Treatment of Patients With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2
COMPLETED427 Analytics
PHASE3COMPLETED
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
Diabetes Mellitus, Type 2
NCT01495013427
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Study Endpoints

Primary Endpoints

Non inferiority of glimepiride/atorvastatin compared with glimepiride + atorvastatin taken as separate tablets in reducing HbA1c levels
Week 20

Change from baseline

Non inferiority of glimepiride/atorvastatin compared with glimepiride + atorvastatin taken as separate tablets in reducing LDL levels
Week 20

Change from baseline

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Glimepiride Atorvastatin fixed dose combinationACTIVE_COMPARATORAll subjects will start on 1mg glimepiride/10 mg atorvastatin fixed dose combination (FDC) and either treatment can be titrated up based on fasting glucose or LDL levels. The following glimepiride/atorvastations FDCs will be available for use 1mg/10mg, 2mg/10mg, 3mg/10mg, 4mg/10mg, 1mg/20mg, 2mg/20mg, 3mg/20mg, 4mg/20mg.
Glimepiride +Atrovastatin loose combinationACTIVE_COMPARATORAll subjects will start on 1mg glimepiride/10 mg atorvastatin loose combination (given as separate tablets) and either treatment can be titrated up based on fasting glucose or LDL levels. Glimepiride single dose tablets are available for 1mg, 2mg, 3mg and 4mg. Atorvastatin single dose tablets are available for 10mg and 20mg.

Interventions

NameTypeDescription
1mg Glimepiride/10mg Atorvastatin FDCDRUG1 tablet by mouth once a day
2mg Glimepiride/10mg Atorvastatin FDCDRUG1 tablet by mouth once a day
3mg Glimepiride/10mg Atorvastatin FDCDRUG1 tablet by mouth once a day
4mg Glimepiride/10mg Atorvastatin FDCDRUG1 tablet by mouth once a day
1mg Glimepiride/20mg Atorvastatin FDCDRUG1 tablet by mouth once a day
2mg Glimepiride/20mg Atorvastatin FDCDRUG1 tablet by mouth once a day
3mg Glimepiride/20mg Atorvastatin FDCDRUG1 tablet by mouth once a day
4mg Glimepiride/20mg Atorvastatin FDCDRUG1 tablet by mouth once a day
1mg GlimepirideDRUG1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
2mg GlimepirideDRUG1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
3mg GlimepirideDRUG1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
4mg GlimepirideDRUG1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
10mg AtorvastatinDRUG1 tablet of Atorvastatin and 1 tablet of Glimepiride co-administered once daily
20mg AtorvastatinDRUG1 tablet of Atorvastatin and 1 tablet of Glimepiride co-administered once daily
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites33

Inclusion Criteria: * Adult (≥18 years of age) males and females ( including of child-bearing potential) with Type 2 diabetes mellitus. * Currently treated for Type 2 daibetes mellitus with metformin monotherapy and have been a stable dose of metformin for atleast 3 months * patients with CVD or ≥4...

Countries:MalaysiaMexicoPhilippinesRussiaSouth KoreaThailand
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