NL-OMON55783已完成3 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 mellitus - DINAMO
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2
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
- 2 至 17（—）
入选标准
- •1. Patients aged 10 to 17 years (inclusive) at the time of randomisation (Visit
- •2. Male and female patients
- •3. Women of childbearing potential (WOCBP)1 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
- •5. Documented diagnosis of T2DM for at least 8 weeks at Visit 1A
- •6. Insufficient glycaemic control as measured by the central laboratory at
- •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 for at least 12 weeks prior to Visit 2)
- •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 as measured by the central
- •laboratory at Visit 1A
- •10. 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
- •11. Compliance with trial medication intake must be between 75% and 125% during
- •the open-label placebo run-in period
排除标准
- •1. Any history of acute metabolic decompensation such as diabetic ketoacidosis
- •within 8 weeks prior to Visit 1A and up to randomisation (mild to moderate
- •polyuria at the time of randomisation is acceptable)
- •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
- •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
- •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
- 另有 2 项未显示
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