CTRI/2017/03/007985已完成3 期
1218-4101: Efficacy and Safety of Faster-acting Insulin Aspart compared toNovoRapid® both in Combination with Insulin Degludec in Childrenand Adolescents with Type 1 Diabetes(ONSET®7) - ONSET®7
ovo Nordisk India Private Ltd0 个研究点目标入组 68 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
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
入选标准
- •Informed consent and child assent, as age-appropriate, obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Legally Acceptable Representative (LAR) of the Subject must sign and date the Informed Consent Form (according to local requirements). The child must sign and date the Child Assent Form or provide oral assent, if required according to local requirements
- •Male or female, 1 <= age < 18 years at the time of signing informed consent and < 18 years at the time of randomisation
- •Diagnosed with type 1 diabetes mellitus (based on clinical judgement and supported by laboratory analysis as per local guidelines)
- •Ongoing daily treatment with a basal-bolus insulin regimen using a basal insulin analogue or NPH insulin for at least 90 days prior to the screening visit
- •Ability and willingness to take at least 3 daily meal-time related bolus insulin injections throughout the trial (Subject and LAR(s) should be evaluated as a unit) Total daily dose of insulin <= 2.0 U/kg prior to the screening visit
- •HbA1c <= 9.5% (80 mmol/mol) analysed by the central laboratory at the screening visit Ability and willingness to adhere to the protocol, including performing self-measured plasma glucose profiles (Subject and LAR(s) should be evaluated as a unit)
- •Willingness to NOT use real time CGM during the trial
排除标准
- •Known or suspected hypersensitivity to trial products or related products
- •Previous participation in this trial. Participation is defined as signed informed consent
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) For EU only: Adequate contraceptive measures are implants, injectable, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner.
- •For Japan only: Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives.
- •Participation in another clinical trial within 28 days before the screening visit
- •Note: Clinical trials do not include non-interventional studies
- •Anticipated initiation or change in concomitant medication in excess of 14 days known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
- •Any condition, which, in the opinion of the Investigator, might jeopardise the Subjects safety or compliance with the protocol (Subject and LAR(s) should be evaluated as a unit)
- •Diagnosis of malignant neoplasms within the last five years prior to the screening visit Known hypoglycaemic unawareness or recurrent severe hypoglycaemic episodes as judged by the Investigator
- •More than one episode of diabetic ketoacidosis requiring hospitalisation within the last 90 days prior to the screening
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening
研究者
相似试验
尚未招募
3 期
Efficacy and Safety of Accelerated Versus Standard Hepatitis B vaccination regimen among End Stage Renal Disease patientsHBV immunization in End Stage Renal DiseaseTCTR20210327001Ratchadaphiseksomphot Endowment Fund132
已完成
不适用
The efficacy and the safety of the new long-acting insulin in patient with diabetesdiabetesJPRN-UMIN000020521Osaka Saiseikai Noe Hospital100
进行中（未招募）
1 期
Rapid ART Initiation with B/F/TAF in HIV people presenting with advanced HIV diseaseEUCTR2019-003614-14-ITISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE LAZZARO SPALLANZANI30
进行中（未招募）
不适用
Comparison of efficacy and tolerability of rapid intravenous infusion of levetiracetam and sodium valproat. - Levetiracetam i.v.Focal epilepsy requiring rapid initiation of anticonvulsant protectionMedDRA version: 8.1Level: LLTClassification code 10034061Term: Partial epilepsy, without mention of impairment of consciousnessEUCTR2006-000869-11-DEeuro-Consil GmbH
已完成
不适用
ong term safety of ultra-long 48mm stentsCTRI/2021/09/036701Department of Cardiology92