Clinical trial NCT01495013 (phase 3, status: completed)
Conditions: diabetes mellitus, type 2
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: 1mg glimepiride/10mg atorvastatin fdc, 2mg glimepiride/10mg atorvastatin fdc, 3mg glimepiride/10mg atorvastatin fdc, 4mg glimepiride/10mg atorvastatin fdc, 1mg glimepiride/20mg atorvastatin fdc, 2mg glimepiride/20mg atorvastatin fdc, 3mg glimepiride/20mg atorvastatin fdc, 4mg glimepiride/20mg atorvastatin fdc, 1mg glimepiride, 2mg glimepiride, 3mg glimepiride, 4mg glimepiride, 10mg atorvastatin, 20mg atorvastatin
SMILES: CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1, CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1, CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1, CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1, CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1, CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1, CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1, CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1, [H][C@]1(C)CC[C@@]([H])(CC1)N=C(O)NS(=O)(=O)C1=CC=C(CCN=C(O)N2CC(C)=C(CC)C2=O)C=C1, [H][C@]1(C)CC[C@@]([H])(CC1)N=C(O)NS(=O)(=O)C1=CC=C(CCN=C(O)N2CC(C)=C(CC)C2=O)C=C1, [H][C@]1(C)CC[C@@]([H])(CC1)N=C(O)NS(=O)(=O)C1=CC=C(CCN=C(O)N2CC(C)=C(CC)C2=O)C=C1, [H][C@]1(C)CC[C@@]([H])(CC1)N=C(O)NS(=O)(=O)C1=CC=C(CCN=C(O)N2CC(C)=C(CC)C2=O)C=C1, CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1, CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1
Eligibility 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