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
NCT ID: NCT01495013
Last Updated: 2016-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
427 participants
INTERVENTIONAL
2011-12-31
2013-09-30
Brief Summary
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Detailed Description
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Atherogenic dyslipidemia, which is defined as the triad of elevated triglycerides, low high-density lipoprotein cholesterol (HDL-C), and small low-density lipoprotein cholesterol (LDL-C) particles, is commonly found in individuals with T2D. In diabetic patients, the LDL particles tend to be smaller, denser, and more atherogenic than in the general population. As a result, in patients with diabetes, lowering LDL-C levels may lead to a greater benefit in terms of Cardiovascular disease (CVD) risk reduction than in patients without diabetes. Multiple clinical trials have demonstrated significant benefits of lipid-lowering (primarily statin) therapy on CVD outcomes for primary and secondary prevention, irrespective of baseline lipid levels. Hence, clinical treatment guidelines recommend that patients with T2D should be treated with both an anti-diabetic agent and a statin.
Glimepiride is an established once-daily sulphonylurea for use as first-line therapy, and is often used in patients who are metformin intolerant, or in those who are failing to achieve glucose control on metformin monotherapy. Atorvastatin is an established statin that is indicated for reducing the risk of cardiovascular events in diabetic patients, without clinically evident coronary heart disease (CHD), irrespective of whether cholesterol is raised. The risk:benefit of both glimepiride and atorvastatin is well established and described in the approved product labels. There is widespread use of both glimepiride and atorvastatin, prescribed separately, in the T2D population. The available literature indicates that there is no drug-drug interaction risk associated with this combination therapy and no clinical PK interactions between atorvastatin and glimepiride have been recorded. A once-daily combination product which combines both glimepiride and atorvastatin will fulfil an unmet clinical need in simplifying patient treatment regimens in a patient population who have a significant disease burden. Providing concurrent access to a statin in patients with T2D, in addition to medication to manage glucose levels, is a critical requirement for ensuring appropriate management of cardio-metabolic risk.
In this study, subjects already on a stable dose of metformin will be randomised to either to receive the glimepiride/atorvastatin fixed dose combination treatment or atorvastatin + glimepiride combination taken as separate tablets. The starting dose for all subjects will be 1mg glimepiride and 10mg atorvastatin. The glimepiride dose will be titrated up if the average fasting glucose is \>7.0mmol/L. The atorvastatin dose will be titrated up if LDL is \>2.6mmol/L.
The purpose of the study is to demonstrate non-inferiority of the glimepiride/atorvastatin fixed dose combination compared with glimepiride +atorvastatin taken as separate tablets in reducing HbA1c and LDL.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Glimepiride Atorvastatin fixed dose combination
All 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.
1mg Glimepiride/10mg Atorvastatin FDC
1 tablet by mouth once a day
2mg Glimepiride/10mg Atorvastatin FDC
1 tablet by mouth once a day
3mg Glimepiride/10mg Atorvastatin FDC
1 tablet by mouth once a day
4mg Glimepiride/10mg Atorvastatin FDC
1 tablet by mouth once a day
1mg Glimepiride/20mg Atorvastatin FDC
1 tablet by mouth once a day
2mg Glimepiride/20mg Atorvastatin FDC
1 tablet by mouth once a day
3mg Glimepiride/20mg Atorvastatin FDC
1 tablet by mouth once a day
4mg Glimepiride/20mg Atorvastatin FDC
1 tablet by mouth once a day
Glimepiride +Atrovastatin loose combination
All 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.
1mg Glimepiride
1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
2mg Glimepiride
1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
3mg Glimepiride
1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
4mg Glimepiride
1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
10mg Atorvastatin
1 tablet of Atorvastatin and 1 tablet of Glimepiride co-administered once daily
20mg Atorvastatin
1 tablet of Atorvastatin and 1 tablet of Glimepiride co-administered once daily
Interventions
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1mg Glimepiride/10mg Atorvastatin FDC
1 tablet by mouth once a day
2mg Glimepiride/10mg Atorvastatin FDC
1 tablet by mouth once a day
3mg Glimepiride/10mg Atorvastatin FDC
1 tablet by mouth once a day
4mg Glimepiride/10mg Atorvastatin FDC
1 tablet by mouth once a day
1mg Glimepiride/20mg Atorvastatin FDC
1 tablet by mouth once a day
2mg Glimepiride/20mg Atorvastatin FDC
1 tablet by mouth once a day
3mg Glimepiride/20mg Atorvastatin FDC
1 tablet by mouth once a day
4mg Glimepiride/20mg Atorvastatin FDC
1 tablet by mouth once a day
1mg Glimepiride
1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
2mg Glimepiride
1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
3mg Glimepiride
1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
4mg Glimepiride
1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
10mg Atorvastatin
1 tablet of Atorvastatin and 1 tablet of Glimepiride co-administered once daily
20mg Atorvastatin
1 tablet of Atorvastatin and 1 tablet of Glimepiride co-administered once daily
Eligibility Criteria
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Inclusion Criteria
* 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-naïve or no statin use for 2 months prior to screening
* Provision of informed consent
Exclusion Criteria
* 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:
* Subjects with end stage renal disease requiring renal replacement therapy
* Subjects receiving drug therapy to treat liver disease
* Subjects with diagnosis of cancer ( other than superficial squamous. basal cell skin cancer or adequately treated cervical carcinoma in situ) in the past 3 years or who are currently receiving treatment for an active cancer ( other than prophylactic)
* Subjects with a clinically significant abnormality identified at screening on physical examination or laboratory tests (including thyroid stimulating hormone) which, in the judgement of the investigator, would preclude safe completion of the study
* Subjects with anaemia defined by a haemoglobin concentration \<10 g/dL (100) g/L) for females and \<12 g/dL (120 g/L) for males or a haemoglobinopathy that could interfere with the assessment of HbA1c
* Subjects with clinically significant liver disease as defined by alanine aminotransferase ( ALT) or aspartate aminotransferase (AST) levels \>2.5 times the upper limit of normal (ULN) or a diagnosis of Chronic active hepatitis including that of viral aetiology, or on antiviral or immunosuppressive therapy
* Subjects with contraindications to or history of hypersensitivity to, the investigational products
* Subjects who are clinically or medically unstable, with expected survival \<1 year
* Subjects with a recent history ( within the last 6 months ) or suspicion of current drug abuse or alcohol abuse
* Any other factor likely to limit protocol compliance or reporting of adverse events
* Previous study participation:
* Participation in another clinical trial of an investigational agent, if the subject has used an investigational agent within 30 days or 5 half lives (whichever is longer) preceding the Screening Visit
* Previous randomisation in this study
Contraception:
* Females of child-bearing potential who are not using highly effective methods for avoiding pregnancy. Highly effective methods include:
* Oral Contraceptive, either combined or progestogen alone
* Injectable progestogen
* Implants of levonorgestrel
* Estrogenic vaginal ring
* Percutaneous contraceptive patches
* Intrauterine device or intrauterine system with a failure rate of less than 1% per year
* Male partner sterilisation (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, "documented" refers to the outcome of the investigator's/designee's medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records
* Double barrier method: condom and an occlusive cap(diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository), including nonoxynol-9
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Ipoh, , Malaysia
GSK Investigational Site
Johor Bahru, , Malaysia
GSK Investigational Site
Kuala Lumpur, , Malaysia
GSK Investigational Site
Kubang Kerian, , Malaysia
GSK Investigational Site
Cuernavaca, , Mexico
GSK Investigational Site
Del. Cuauhtémoc, , Mexico
GSK Investigational Site
Gadalajara, Jalisco, , Mexico
GSK Investigational Site
Guadalajara Jalisco, , Mexico
GSK Investigational Site
Mexico City, , Mexico
GSK Investigational Site
Mexico City, , Mexico
GSK Investigational Site
Cebu City, , Philippines
GSK Investigational Site
Davao City, , Philippines
GSK Investigational Site
Manila, , Philippines
GSK Investigational Site
Pasig, , Philippines
GSK Investigational Site
Santa Cruz, Manila, , Philippines
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Saint Petersburg, , Russia
GSK Investigational Site
Saratov, , Russia
GSK Investigational Site
Bucheon-si, , South Korea
GSK Investigational Site
Busan, , South Korea
GSK Investigational Site
Kangwondo, , South Korea
GSK Investigational Site
Seocho-ku, Seoul, , South Korea
GSK Investigational Site
Seongnam-si Gyeonggi-do, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Suwon, , South Korea
GSK Investigational Site
Chiangrai, , Thailand
GSK Investigational Site
Nakhon Ratchasima, , Thailand
GSK Investigational Site
Rajathevee, , Thailand
Countries
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Study Documents
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Document Type: Dataset Specification
View DocumentDocument Type: Statistical Analysis Plan
View DocumentDocument Type: Clinical Study Report
View DocumentDocument Type: Study Protocol
View DocumentDocument Type: Individual Participant Data Set
View DocumentDocument Type: Informed Consent Form
View DocumentRelated Links
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Other Identifiers
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115317
Identifier Type: -
Identifier Source: org_study_id