Last updated: 11/07/2018 09:10:21
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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A non-inferiority study of Glimepiride/Atorvastatin FDC compared to glimepiride and atorvastatin as separate tablets in Type II diabetic subjects.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Change from Baseline (Day 1) to Week 20 in glycosylated hemoglobin (HbA1c) levels
Timeframe: Baseline (Day 1) and Week 20
Percent change from Baseline (Day 1) to Week 20 in LDL-c levels
Timeframe: Baseline (Day 1) and Week 20
Secondary outcomes:
Change in HbA1c from Baseline (Day 1) at Week 12
Timeframe: Baseline (Day 1) and Week 12
Percent change in LDL-c from Baseline (Day 1) at Week 4 and Week 10
Timeframe: Baseline (Day 1) and Weeks 4 and 10
Interventions:
Drug: 1mg Glimepiride/10mg Atorvastatin FDC
Drug: 2mg Glimepiride/10mg Atorvastatin FDC
Drug: 3mg Glimepiride/10mg Atorvastatin FDC
Drug: 4mg Glimepiride/10mg Atorvastatin FDC
Drug: 1mg Glimepiride/20mg Atorvastatin FDC
Drug: 2mg Glimepiride/20mg Atorvastatin FDC
Drug: 3mg Glimepiride/20mg Atorvastatin FDC
Drug: 4mg Glimepiride/20mg Atorvastatin FDC
Drug: 1mg Glimepiride
Drug: 2mg Glimepiride
Drug: 3mg Glimepiride
Drug: 4mg Glimepiride
Drug: 10mg Atorvastatin
Drug: 20mg Atorvastatin
Enrollment:
427
Observational study model:
Not applicable
Primary completion date:
2013-20-09
Time perspective:
Not applicable
Clinical publications:
P. Ambery, A. Stylianou, G. Atkinson, C. Dott, L. Baylor Curtis, N. Haque, K. LaCroix and K. W. Min. An open-label randomised non-inferiority trial of a fixed-dose combination of glimepiride and atorvastatin for the treatment of people whose type 2 diabetes is uncontrolled on metformin. Diabet Med. 2016;33(8):1084-1093.
Medical condition
Diabetes Mellitus, Type 2
Product
atorvastatin/glimepiride, glimepiride
Collaborators
Not applicable
Study date(s)
December 2011 to September 2013
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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
- Concomitant treatment:
- Concomitant treatment with statins other than study medication
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Guadalajara Jalisco, Mexico, C.P. 44210
Status
Study Complete
Location
GSK Investigational Site
Seocho-ku, Seoul, South Korea, 137-701
Status
Study Complete
Location
GSK Investigational Site
Seongnam-si Gyeonggi-do, South Korea, 463-707
Status
Study Complete
Location
GSK Investigational Site
Gadalajara, Jalisco, Mexico, C.P. 44130
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2013-20-09
Actual study completion date
2013-20-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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