EUCTR2011-000828-15-HU
进行中（未招募）
不适用
A Prospective, Randomized, Double-Blind Comparisonof a Long-Acting Basal Insulin Analog LY2963016 toLantus® in Adult Patients with Type 2 Diabetes Mellitus - The ELEMENT 2 Study
适应症type 2 diabetes mellitusMedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
相关药物Lantus
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- type 2 diabetes mellitus
- 发起方
- Eli Lilly and Company
- 入组人数
- 792
- 状态
- 进行中（未招募）
- 最后更新
- 13年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\[1] Have T2DM based on the disease diagnostic criteria World Health
- •Organization (WHO) classification.
- •\[2] Are \=18 years of age.
- •\[3] Have been receiving 2 or more OAMs at stable doses for the 12
- •weeks prior to Visit 1, with or without Lantus. Note: use and dose of oral
- •agents in combination with insulin must be in accordance with the local product label. Patients taking metformin and who are found to have a
- •contraindicated serum creatinine level (\=1\.4 mg/dL \[123\.8 µmol/L] for
- •females, \=1\.5 mg/dL \[132\.6 µmol/L] for males, or based on countryspecific
- •label) must be willing to discontinue use of metformin at
- •randomization.
排除标准
- •\[8] Have used any other insulin except Lantus, including commercial and
- •investigational insulins within the previous 30 days.
- •\[9] Have been exposed to a biosimilar insulin glargine within the
- •previous 90 days.
- •\[10] Have a history of taking basal bolus therapy or who, in the
- •investigator's opinion, require mealtime insulin in order to achieve
- •target control.
- •\[11] Have used short\-acting glucagon like peptide (GLP\-1\) agonist (eg,
- •exenatide) or long\-acting GLP\-1 agonist (eg, liraglutide) within the
- •previous 90 days.
结局指标
主要结局
未指定
相似试验
进行中（未招募）
1 期
A study in people with type 1 diabetes to determine how well a meal-time insulin, LY900014, controls diabetes compared to Humalog (insulin lispro) when both are used along with a long-acting insulin.Type 1 DiabetesMedDRA version: 20.1 Level: LLT Classification code 10020639 Term: Hyperglycemia System Organ Class: 100000004861Therapeutic area: Diseases [C] - Hormonal diseases [C19]EUCTR2015-005356-99-DEEli Lilly and Company1,567
进行中（未招募）
1 期
A study in people with type 1 diabetes to determine how well a meal-time insulin, LY900014, controls diabetes compared to Humalog (insulin lispro) when both are used along with a long-acting insulin.Type 1 DiabetesMedDRA version: 20.1Level: LLTClassification code 10020639Term: HyperglycemiaSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Hormonal diseases [C19]EUCTR2015-005356-99-ITELI LILLY & COMPANY, LILLY CORPORATE CENTER1,392
进行中（未招募）
1 期
A study in people with type 1 diabetes to determine how well a meal-time insulin, LY900014, controls diabetes compared to Humalog (insulin lispro) when both are used along with a long-acting insulin.Type 1 DiabetesMedDRA version: 20.1 Level: LLT Classification code 10020639 Term: Hyperglycemia System Organ Class: 100000004861Therapeutic area: Diseases [C] - Hormonal diseases [C19]EUCTR2015-005356-99-ATEli Lilly and Company1,567
进行中（未招募）
1 期
A study to compare an investigational ultra-rapid insulin, LY900014 with insulin lispro in children with type 1 diabetesDiabetes Mellitus, Type 1MedDRA version: 21.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Hormonal diseases [C19]EUCTR2018-002371-18-ITELI LILLY & COMPANY, LILLY CORPORATE CENTER751
进行中（未招募）
不适用
A Prospective, Randomized, Double-Blind Comparisonof a Long-Acting Basal Insulin Analog LY2963016 toLantus® in Adult Patients with Type 2 Diabetes Mellitus - The ELEMENT 2 Studytype 2 diabetes mellitusMedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]EUCTR2011-000828-15-DEEli Lilly and Company792