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
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ClinicalTrials.gov Identifier: NCT01495013 |
Recruitment Status
:
Completed
First Posted
: December 19, 2011
Last Update Posted
: November 21, 2016
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Tracking Information | |||||
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First Submitted Date ICMJE | December 15, 2011 | ||||
First Posted Date ICMJE | December 19, 2011 | ||||
Last Update Posted Date | November 21, 2016 | ||||
Study Start Date ICMJE | December 2011 | ||||
Actual Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01495013 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | 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 | ||||
Official Title ICMJE | 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 | ||||
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. | ||||
Detailed Description | Patients diagnosed with Type 2 diabetes (T2D) are initially provided with lifestyle advice in order to manage the condition by diet, exercise and weight reduction, followed by treatment with metformin. However, many patients do not gain adequate control of fasting glucose by these methods and other anti-diabetic agents are needed. Furthermore, these patients have an increased cardiovascular risk compared with the general population. Approximately one half of patients with T2D die prematurely of a cardiovascular cause and approximately 10% die of renal failure. 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Diabetes Mellitus, Type 2 | ||||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
427 | ||||
Original Estimated Enrollment ICMJE |
424 | ||||
Actual Study Completion Date | September 2013 | ||||
Actual Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Contraception:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Korea, Republic of, Malaysia, Mexico, Philippines, Russian Federation, Thailand | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01495013 | ||||
Other Study ID Numbers ICMJE | 115317 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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Responsible Party | GlaxoSmithKline | ||||
Study Sponsor ICMJE | GlaxoSmithKline | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | GlaxoSmithKline | ||||
Verification Date | November 2016 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |