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

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Atorvastatin; Atorvastatin Calcium; Glimepiride

Criteria

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 ≥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:

• 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