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
Study ATG115317, 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
1 other identifier
interventional
427
6 countries
33
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 diabetes-mellitus-type-2
Started Dec 2011
Typical duration for phase_3 diabetes-mellitus-type-2
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 15, 2011
CompletedFirst Posted
Study publicly available on registry
December 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedNovember 21, 2016
November 1, 2016
1.3 years
December 15, 2011
November 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Non inferiority of glimepiride/atorvastatin compared with glimepiride + atorvastatin taken as separate tablets in reducing HbA1c levels
Change from baseline
Week 20
Non inferiority of glimepiride/atorvastatin compared with glimepiride + atorvastatin taken as separate tablets in reducing LDL levels
Change from baseline
Week 20
Study Arms (2)
Glimepiride Atorvastatin fixed dose combination
ACTIVE 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 combination
ACTIVE 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
1 tablet by mouth once a day
1 tablet by mouth once a day
1 tablet by mouth once a day
1 tablet by mouth once a day
1 tablet by mouth once a day
1 tablet by mouth once a day
1 tablet by mouth once a day
1 tablet by mouth once a day
1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
1 tablet of Atorvastatin and 1 tablet of Glimepiride co-administered once daily
1 tablet of Atorvastatin and 1 tablet of Glimepiride co-administered once daily
Eligibility Criteria
You may qualify if:
- 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 ≥40 years old with a cardiovascular risk factor, or \<40 years old with LDL-C level 100mg/dL
- HbA1c levels ≥7.0 and \<9.5% at screening or within 3 months prior to study enrollment
- Fasting blood glucose \>7.0 mmol/L on 4 days in a week
- Statin-naĂŻve or no statin use for 2 months prior to screening
- Provision of informed consent
You may not qualify if:
- Concomitant treatment:
- Concomitant treatment with statins other than study medication
- Concomitant treatment with fenofibrate or other lipid lowering agents
- concomitant treatment with anti-diabetic therapy other than study treatment or change in metformin monotherapy for subjects already treated with metformin
- Concurrent diseases and symptoms:
- Subjects with Type 1 diabetes or who have a current need for insulin therapy
- Subjects with symptomatic hyperglycaemia requiring immediate therapy in the judgement of the investigator
- Subjects with myalgia
- Significant hypertriglyceridaemia as defined by fasting triglycerides \>3.5 mmol/L
- Clinically significant ongoing cardiovascular disease:
- Subjects who have had an acute cardiovascular event within 30 days prior to randomisation
- Subjects with unstable or severe angina, coronary insufficiency or New York Heart Association class III-IV heart failure
- subjects with a prior heart transplant or who are awaiting a heart transplant
- Subjects with systolic blood pressure \>160 mmHg or diastolic blood pressure \>90 mmHg while on anti-hypertensive treatment
- General Health:
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (33)
GSK Investigational Site
Ipoh, 30450, Malaysia
GSK Investigational Site
Johor Bahru, 80100, Malaysia
GSK Investigational Site
Kuala Lumpur, 59100, Malaysia
GSK Investigational Site
Kubang Kerian, 16150, Malaysia
GSK Investigational Site
Cuernavaca, 62250, Mexico
GSK Investigational Site
Del. Cuauhtémoc, 06700, Mexico
GSK Investigational Site
Gadalajara, Jalisco, C.P. 44130, Mexico
GSK Investigational Site
Guadalajara Jalisco, C.P. 44210, Mexico
GSK Investigational Site
Mexico City, 06700, Mexico
GSK Investigational Site
Mexico City, 11650, Mexico
GSK Investigational Site
Cebu City, 6000, Philippines
GSK Investigational Site
Davao City, 8000, Philippines
GSK Investigational Site
Manila, 1008, Philippines
GSK Investigational Site
Pasig, 1600, Philippines
GSK Investigational Site
Santa Cruz, Manila, 1012, Philippines
GSK Investigational Site
Moscow, 109240, Russia
GSK Investigational Site
Saint Petersburg, 191119, Russia
GSK Investigational Site
Saratov, 410054, Russia
GSK Investigational Site
Bucheon-si, 134 727, South Korea
GSK Investigational Site
Busan, 602-739, South Korea
GSK Investigational Site
Kangwondo, 220-701, South Korea
GSK Investigational Site
Seocho-ku, Seoul, 137-701, South Korea
GSK Investigational Site
Seongnam-si Gyeonggi-do, 463-707, South Korea
GSK Investigational Site
Seoul, 110-744, South Korea
GSK Investigational Site
Seoul, 110-746, South Korea
GSK Investigational Site
Seoul, 135-710, South Korea
GSK Investigational Site
Seoul, 138-736, South Korea
GSK Investigational Site
Seoul, 139-872, South Korea
GSK Investigational Site
Seoul, 152-703, South Korea
GSK Investigational Site
Suwon, 463442, South Korea
GSK Investigational Site
Chiangrai, 57000, Thailand
GSK Investigational Site
Nakhon Ratchasima, 30000, Thailand
GSK Investigational Site
Rajathevee, 10400, Thailand
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2011
First Posted
December 19, 2011
Study Start
December 1, 2011
Primary Completion
April 1, 2013
Study Completion
September 1, 2013
Last Updated
November 21, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.