NL-OMON38357已完成3 期
A phase III randomised, double-blind, active-controlled parallel group efficacy and safety study of BI 10773 compared to glimepiride administered orally during 104 weeks with a 104-week extension period in patients with type 2 diabetes mellitus and insufficient glycaemic control despite metformin treatment - C-SCADE-7
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 18
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •(see paragraph 3.3.2 of the protocol for the complete list)
- •1. Diagnosis of type 2 diabetes mellitus prior to informed consent
- •2. Male and female patients on diet and exercise regimen who are
- •pre-treated with immediate release metformin unchanged for 12 weeks prior to
- •randomisation. Minimum dose for metformin: > <= 1500 mg/day or maximum tolerated
- •dose (the investigator must have documented the reason why up-titration to ><= 1500
- •mg/day was not possible) or maximum dose according to local label.
- •3. HbA1c of *7.0% and * 10% at Visit 1
- •4. Age * 18yrs
- •5. BMI * 45 kg/m2 (Body Mass Index) at Visit 1
- •6. Signed and dated written informed consent by date of Visit 1 in accordance with GCP and
- •local legislation
排除标准
- •(see paragraph 3.3.3 of the protocol for the complete list)
- •1. Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L) after an
- •overnight fast during placebo run-in and confirmed by a second measurement after an
- •overnight fast using another device (not on the same day).
- •2. Any other antidiabetic drug within 12 weeks prior to randomisation except immediate release metformin
- •3. Acute coronary syndrome (non-STEMI, STEMI, unstable AP) Stroke or TIA within 3
- •months prior to informed consent.
- •4. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST
- •(SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1
- •5. Impaired renal function, defined as eGFR<60 ml/min (moderate to severe renal impairment using MDRD formula)
- •6. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
- •7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
- •8. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia)
- •9. Contraindications including hypersensitivity known to metformin or sulfonylureas according to the local label
- •10. Treatment with anti-obesity drugs 3 months prior to informed
- •consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
- •11. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM. (Treatment with local and inhaled steroids is allowed)
- •12. Pre-menopausal women (last menstruation * 1 year prior to informed consent) who:
- •- are nursing or pregnant or
- •- are of child-bearing potential and are not practising an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
- •Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence, (if acceptable by local authorities) double barrier method and vasectomised partner
- •13. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
- •14. Intake of an investigational drug in another trial within 30 days prior to intake of
- •study medication in this trial.
- •15. Any other clinical condition that would jeopardize patients safety while participating in
- •this clinical trial
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