Lipoatrophy in Children, Adolescents and Adults With Modern Treatment Modalities: is There a Beneficial Effect of Insulin Glulisine?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 主要终点
- Relative thickness as assessed by MRI
研究概览
简要总结
The purpose of this study is to investigate whether a zinc-free insulin is an effective treatment option for lipoatrophy in patients with type 1 Diabetes (T1D) and insulin pump (CSII, continuous subcutaneous insulin infusion) therapy.
详细描述
Randomized, controlled, open-label parallel study. Clinical Study Phase IV After being included in the study, subjects are getting an extensive dermatological examination by a pediatric dermatologist familiar with cutaneous complications of T1D, additionally pathological results will be documented by photography and, if necessary, videodermoscopy. Additionally, an evaluation of their lipoatrophic areas using imaging methods like ultrasound (USG) and MRI will be performed. After randomization, half of the included children switch their pump insulin into insulin glulisine (intervention group) for 6 months. The others continue their current treatment (control group) and switch to insulin glulisine 6 months later. Both groups are followed-up until month 12. Hence, after the 4th visit at 6 months, all enrolled patients are on insulin glulisine pumps for a further period of 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 1 diabetes and documented lipoatrophy at injection sites on CSII treatment
- •Age between 6 and 40 years (both inclusive, see rationale for the inclusion of minors above)
- •Signed informed consent form from patients or from parents/their guardians if children/youths <18 years
- •Patients must be willing to undergo all study procedures
排除标准
- •Patients with previous use of insulin glulisine
- •Patients requiring corticosteroids as treatment medication. NOTE inhaled corticosteroids are allowed.
- •Patients suffering from severe chronic disease other than T1D or genetic disorder (i.e. Down syndrome etc.)
- •Pregnant or lactating women
- •Patients participating in other device or drug studies
- •History of drug or alcohol abuse within the last five years prior to screening
- •Anamnestic history of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures
- •History of severe or multiple allergies
- •Treatment with any other investigational drug within 3 months prior to screening
- •Progressive fatal disease
- •History of significant cardiovascular (such as myocardial infarction, stroke, TIA), respiratory, gastrointestinal, hepatic (ALT and/or AST > 3 times the normal reference range), renal (creatinine > 1.1 mg/dl in women and > 1.5 mg/dl in men), neurological, psychiatric and/or hematological disease as judged by the investigator
- •Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner
- •Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study
- •Prisoners or subjects who are involuntarily incarcerated
- •Target Disease Exclusions
- •History of T2DM, maturity onset diabetes of young (MODY), pancreatic surgery or chronic pancreatitis
- •Any use of oral hypoglycemic agents within 12 months prior to the screening visit
- •History of diabetes ketoacidosis (DKA) within 12 weeks prior to the screening visit
- •History of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 3 months prior to the screening visit
- •Frequent episodes of hypoglycemia as defined by more than one episode requiring assistance, emergency care (paramedics or emergency room care) or glucagon therapy, or more than 2 unexplained episodes of symptomatic hypoglycemia within 3 months prior to the screening visit. An unexplained event is defined as an event that cannot be explained by circumstances such as dietary (e.g. missed meal), strenuous exercise, error in insulin dosing, etc.
- •Hypoglycemic unawareness
- •History of diabetes insipidus
- •History of Addison's disease or chronic adrenal insufficiency
- •Physical and Laboratory Test Findings
- •BMI above 35 kg/m2
- •RR > 180/110 mm Hg
- •Aspartate aminotransferase (AST) > 3X Upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) > 3X ULN
- •Serum total bilirubin > 3X ULN
- •Estimated GFR (eGFR) < 60 ml/min/1.73 m2
- •Hemoglobin ≤ 11.0 g/dl (110 g/l) for boys / men; hemoglobin ≤10.0 g/dl (100 g/L) for girls / women.
- •Creatine kinase (CK) > 3X ULN
- •Positive for hepatitis B surface antigen or anti-hepatitis C virus antibody.
- •Abnormal Free T4 Note: abnormal TSH value at screening will be further evaluated for free T
- •Subjects with abnormal free T4 values will be excluded. A one-time retest may be allowed, as determined by the Investigator, after a minimum of 6 weeks following the adjustment of thyroid hormone replacement therapy in subject who have had a prior diagnosis of a thyroid disorder and who are currently receiving thyroid replacement therapy. Such cases should be discussed with the Investigator prior to retesting.
研究组 & 干预措施
Group 1
Daily use of insulin Apidra in insulin pump. The dosis will be according to the patient's former dosing scheme.
干预措施: Apidra (Drug)
Group 2
Daily use of current insulin in insulin pump.The dosis will be according to the patient's former dosing scheme.
干预措施: current insulin (Drug)
结局指标
主要结局
Relative thickness as assessed by MRI
时间窗: at 6 months
The relative thickness will be used instead of raw data of the MRI measurements as given by the thickness of the most atrophic region related to the thickness of the reference region of the same patient (normal tissue). The change (increase) of the thickness is defined as difference between the relative thicknesses of the same atrophic region (given as percentage of the same reference region) at 6 months and study begin.
次要结局
- Relative thickness as assessed by MRI(at baseline and 12 months)
- Glycemic control(at 6 and 12 months)
- Insulin requirements(at 6 and 12 months)
- Laboratory findings(at baseline, 6 months and 12 months)
- Side effects(within 12 months)
- Relative thickness as assessed by USG(at baseline and 12 months)
- indicator dermatoses of Diabetes mellitus and associated autoimmune disorders of the skin(at 6 and 12 months)
- Number of new lipoatrophic areas(at 6 and 12 months)
研究者
Olga Kordonouri
Prof. Dr. (MD)
Kinderkrankenhaus auf der Bult