EUCTR2016-000669-21-DE进行中（未招募）1 期
A double-blind, randomised, placebo-controlled, parallel group trial to evaluate the efficacy and safety of empagliflozin and linagliptin over 26 weeks, with a double-blind active treatment safety extension period up to 52 weeks, in children and adolescents with type 2 diabetes mellitusEmpagliflozin: EMA Decision number of PIP: P/028/2018
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 186
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients aged 10 to 17 years (inclusive) at the time of randomisation (Visit 2)
- •2. Male and female patients
- •3. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient’s legal representative information sheet as well as in Section 4.2.2.3.
- •4. Signed and dated written informed consent provided by the patient’s parent(s) (or legal guardian) and patient’s assent in accordance with ICH-GCP and local legislation prior to admission to the trial (informed assent will be sought according to the patient’s age, level of maturity, competence and capacity)
- •5. Documented diagnosis of T2DM at Visit 1A
- •a. DINAMOTM: Documented diagnosis of T2DM for at least 8 weeks at Visit 1a
- •b. DINAMOTM Mono: Confirmation of T2DM at Visit 1A
- •6. Insufficient glycaemic control as measured by the central laboratory at Visit 1A:
- •a. DINAMOTM: HbA1c = 6.5% and = 10.5%
- •b. DINAMOTM Mono: HbA1c = 6.5% and = 9.0%
- •7. a. DINAMOTM: Patients treated with
- •- diet and exercise plus metformin at least 1000 mg/day (or up to a maximal tolerated dose) at a stable dose for 8 weeks prior to Visit 2 or not tolerating metformin (defined as patients who were on metformin treatment for at least 1 week and had to discontinue metformin due to metformin-related side effects as assessed by the investigator)
- •- diet and exercise plus stable basal or MDI insulin therapy, defined as a weekly average variation of the basal insulin dose = 0.1 IU/kg over 8 weeks prior to Visit 2
- •b. DINAMOTM Mono: Drug-naïve patients or patients not on active treatment (including discontinuation of metformin due to intolerance [or previous discontinuation for other reasons] and/or discontinuation of insulin [insulin use must be 8 weeks or less] at investigator's discretion) prior to or at Visit 1A)
- •8. BMI = 85th percentile for age and sex according to WHO references at Visit 1B
- •9. Non-fasting serum C-peptide levels = 0.6 ng/ml or >0.199 nmol/L as measured by the central laboratory at Visit 1A
- •10. Compliance with trial medication intake must be between 75% and 125% during the open-label placebo run-in period
- •11. Negative for both islet cell antigen auto-antibodies (IA-2) and glutamic acid decarboxylase (GAD) auto-antibodies as measured by the central laboratory at Visit 1A
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 186
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any history of acute metabolic decompensation such as diabetic
- •ketoacidosis
- •a) within 8 weeks prior to Visit 1A and up to randomisation (mild to moderate polyuria at the time of randomisation is acceptable)
- •b) Any medical history of ketoacidosis requiring emergency medical care.
- •2. Diagnosis of monogenic diabetes (e.g. MODY)
- •3. History of pancreatitis
- •4. Diagnosis of metabolic bone disease
- •5. Gastrointestinal disorders that might interfere with study drug
- •absorption according to investigator assessment
- •6. Secondary obesity as part of a syndrome (e.g. Prader-Willi syndrome)
- •7. Any antidiabetic medication (with the exception of metformin and/or insulin background therapy for DINAMOTM) within 8 weeks prior to Visit 1A and until Visit 2
- •8. Treatment with weight reduction medications (including anti-obesity drugs) within 3 months prior to Visit 1A and until Visit 2
- •9. History of weight-loss surgery or current aggressive diet regimen
- •(according to investigator assessment) at Visit 1A and until Visit 2
- •10. Treatment with systemic corticosteroids for > 1 week within 4 weeks prior to Visit 1A and up to Visit 2. Inhaled or topical use of
- •corticosteroids (e.g. for asthma/chronic obstructive pulmonary disease) is acceptable.
- •11. Change in dose of thyroid hormones within 6 weeks prior to Visit 1A or planned change or initiation of such therapy before Visit 2
- •12. Known hypersensitivity or allergy to the investigational products or their excipients
- •13. Impaired renal function defined as estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m² (according to Zappitelli formula) as measured by the central laboratory at Visit 1A
- •14. Indication of liver disease defined by serum level of either alanine transaminase (ALT), aspartate transaminase (AST) or alkaline
- •phosphatase above 3 fold upper limit of normal (ULN) at Visit 1A as
- •measured by the central laboratory at Visit 1A
- •15. History of belonephobia (needle phobia)
- •16. Any documented active or suspected malignancy or history of
- •malignancy within 5 years prior to Visit 1A, except appropriately treated basal cell carcinoma of the skin or in situcarcinoma of uterine cervix
- •17. Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells (e.g. malaria, babesiosis, haemolytic anaemia)
- •18. Any other acute or chronic medical or psychiatric condition or
- •laboratory abnormality that, based on investigator's judgement, would jeopardize patient safety during trial participation or would affect the study outcome
- •19. Medical contraindications to metformin according to the local label (for patient on metformin background therapy)
- •20. Patient not able or cannot be supported by his/her parent(s) or legal guardian to understand and comply with study requirements based on investigator's judgement
- •21. Previous randomisation in this trial
- •22. Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s), or receiving other investigational treatment(s)
- •23. Chronic alcohol or drug abuse within 3 months prior to Visit 1A or any condition that, in the investigator's opinion, makes them an
- •unreliable trial patient or unlikely to complete the trial
- •24. Female patients who are pregnant, nursing, or who plan to become pregnant in the Trial
- •25. Known recurrent urinary tract infections.
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