NL-OMON44650已完成3 期
A Phase III, randomised, double blind, placebo-controlled, parallel group, efficacy, safety and tolerability trial of once daily, oral doses of empagliflozin as adjunctive to insulin therapy over 26 weeks in patients with Type 1 Diabetes Mellitus (EASE-3) - EASE-3
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Signed and dated written informed consent
- •- Male or female patient receiving insulin for the treatment of documented diagnosis of type 1 diabetes mellitus (T1DM) for at least 1 year
- •- C-peptide value of < 0.7 ng/mL (0.23 nmol/L) at visit 2
- •- Use of Multiple Daily Injections (MDI) of insulin or insulin pump user with total daily insulin * 0.3 and * 1.5 U/kg
- •- Glycated haemoglobin (HbA1c) * 7.5% and * 10.0%
- •- Good understanding of T1DM
- •- Age * 18 years
- •- Body Mass Index (BMI) * 18.5 kg/m2
- •- Estimated glomerular filtration rate (eGFR) * 30 mL/min/1.73 m2
- •- Women of child-bearing potential must use highly effective methods of birth control
- •- Compliance with trial medication administration between 80% and 120% during placebo run-in period;Further inclusion criteria apply, see protocol section 3.3.2.
排除标准
- •- History of type 2 diabetes mellitus, maturity onset diabetes of the young (MODY), pancreatic surgery or chronic pancreatitis
- •- Pancreas, pancreatic islet cells or renal transplant recipient
- •- T1DM treatment with any other antihyperglycaemic drug except subcutaneous basal and bolus insulin within last 3 months
- •- Occurrence of severe hypoglycaemia within last 3 months prior to Visit 1 and until Visit 6
- •- Occurence of diabetic ketoacidosis within 3 months prior to Visit 1 and until Visit 6
- •- Irregular sleep/wake cycle
- •- Acute coronary syndrome, stroke or TIA within last 3 months
- •- Severe gastroparesis
- •- Brittle diabetes
- •- Liver disease
- •- Eating disorders
- •- Treatment with anti-obesity drugs, weight-loss surgery or aggressive diet regimen
- •- Treatment with systemic corticosteroids at Visit 1 and until Visit 6
- •- Change in dose of thyroid hormones within last 6 weeks to Visit 1 and until Visit 6
- •- Cancer or treatment for cancer in the last five years
- •- Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells
- •- Women who are pregnant, nursing, or who plan to become pregnant whilst in the trial
- •- Alcohol or drug abuse
- •- Intake of an investigational drug in another trial within last 30 days;Further exclusion criteria apply, see protocol section 3.3.3.
研究者
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