NCT03345004已完成2 期
A Phase IIb, 2-Arm, Randomized, Double-blind, Placebo-Controlled, Multicentre Study to Optimize Diamyd Therapy Administered Into Lymph Nodes Combined With Oral Vitamin D to Investigate the Impact on the Progression of Type 1 Diabetes
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 36
- 主要终点
- Change in Stimulated C-peptide During a MMTT
研究概览
简要总结
The objective of DIAGNODE-2 is to evaluate the efficacy of Diamyd compared to Placebo, upon administration directly into a lymph node in combination with an oral vitamin D/Placebo regimen, in terms of preserving endogenous insulin secretion as measured by C-peptide.
详细描述
The study is a 2-arm, randomized, double-blind, placebo-controlled, multicenter, clinical trial. Eligible patients will receive injections of Diamyd/placebo into an inguinal lymph gland at three occasions, with one month intervals in combination with an oral vitamin D/placebo regimen (starting 1 month ahead of injections) during 4 months. All patients will continue to receive intensive insulin treatment from their personal physicians during the whole study period. The patients will be followed in a blinded manner for a total of 15 months. All patients that have not performed the 15 months visit when the updated protocol is implemented, will be asked to participate in the Extension Study Period which includes an additional visit at month 24.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent given by patients and/or patient's parent(s) or legal acceptable representative(s) (guardian(s)) according to national regulations
- •Type 1 Diabetes (T1D) according to the Amercian Diabetes Association (ADA) classification diagnosed ≤6 months at the time of screening
- •Age: ≥12 and <25 years old
- •Fasting C-peptide ≥0.12 nmol/L (0.36 ng/ml) on at least one occasion (maximum 2 tests on different days within a period of 2 weeks)
- •Positive for Glutamic Acid Decarboxylase isoform 65 (GAD65A) but < 50 000 IU/ml
- •Females must agree to avoid pregnancy and have a negative urine pregnancy test. Patients of childbearing potential must agree to use adequate contraception, until one (1) year after the last administration of Diamyd. Adequate contraception is as follows:
- •For females of childbearing potential:
- •oral (except low-dose gestagen (lynestrenol and norestisteron)), injectable, or implanted hormonal contraceptives
- •combined (estrogen and progestogen containing)
- •oral, intravaginal or transdermal progesterone hormonal contraception associated with inhibition of ovulation
- •intrauterine device
- •intrauterine hormone-releasing system (for example, progestin-releasing coil)
- •bilateral tubal occlusion
- •vasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate)
- •male partner using condom
- •abstinence from heterosexual intercourse
- •For males of childbearing potential:
- •condom (male)
- •abstinence from heterosexual intercourse
排除标准
- •Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
- •Continuous treatment with anti-inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
- •Treatment with any oral or injected anti-diabetic medications other than insulin
- •A history of anemia or significantly abnormal hematology results at screening
- •A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles
- •Clinically significant history of acute reaction to vaccines or other drugs in the past
- •Treatment with any vaccine, including influenza vaccine, within 4 months prior to planned first study drug dose or planned treatment with any vaccine up to 4 months after the last injection with study drug.
- •Participation in other clinical trials with a new chemical entity within the previous 3 months
- •Inability or unwillingness to comply with the provisions of this protocol
- •A history of alcohol or drug abuse
- •A significant illness other than diabetes within 2 weeks prior to first dosing
- •Known HIV or hepatitis
- •Females who are lactating or pregnant (the possibility of pregnancy must be excluded by urine βHCG on-site within 24 hours prior to the Diamyd/placebo treatment)
- •Presence of associated serious disease or condition, including active skin infections that preclude intralymphatic injection, which in the opinion of the investigator makes the patient non-eligible for the study
- •Deemed by the investigator not being able to follow instructions and/or follow the study protocol
结局指标
主要结局
Change in Stimulated C-peptide During a MMTT
时间窗: Baseline and 15 months
Change in C-peptide between Baseline and 15 Months. C-peptide was measured by Area Under the Curve \[AUC\] at 0-120 min during a Mixed Meal Tolerance Test (MMTT) and divided by 120 min. The results are given as the ratio (back-transformed from log-scale) between 15 Months and Baseline as predicted by the MMRM (Mixed Model Repeated Measures) model.
次要结局
- Change in IDAA1c(Baseline and 15 months)
- Change in HbA1c(Baseline and 15 months)
- Change in Insulin Consumption(Baseline and 15 months)
- Change in Glycemic Variability/Fluctuations(Screening and 15 months)
- Percentage of Patients With IDAA1c ≤ 9(15 months)
- Stimulated C-peptide Above 0.2 Nmol/L at 90 Min(15 months)
- Number of Patients Having at Least 1 Severe Hypoglycemic Event(Baseline and 15 months)
- Number of Hypoglycemias(Baseline and 15 months)
- C-peptide Levels During a MMTT(15 months)
- Change in Body Weight(Baseline and 15 months)
- Number of Clinically Significant Abnormal Results From Laboratory Measurements (Haematology and Clinical Chemistry) and Urinalysis.(15 months)
- Number of Clinically Significant Abnormal Results From Physical and Neurological Examinations(15 months)
- GAD65A Titer(Baseline and 15 months)
- Stimulated Maximum C-peptide Above 0.2 Nmol/L(15 months)
- Change in Maximum C-peptide(Baseline and 15 months)
- Change in Fasting C-peptide(Baseline and 15 months)
- Number of Clinically Significant Abnormal Results in Vital Signs(15 months)
- Change in Body Mass Index (BMI)(Baseline and 15 months)
- Injection Site Reactions(15 months)
- Change in Quality of Life (QoL)(Baseline and 15 months)
研究者
研究点 (36)
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