EUCTR2008-008296-33-FI进行中（未招募）不适用
A Phase III randomised, double-blind, placebo-controlled, parallel group efficacy and safety study of Linagliptin (5 mg), administered orally once daily for at least 52 weeks in type 2 diabetic patients in combination with basal insulin therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Diagnosis of type 2 diabetes mellitus, confirmed by a measurable C-peptide level at Visit 1 (screening)
- •2. Pre-treatment with basal insulin alone or basal insulin in combination with Metformin or/and Pioglitazone. Acceptable basal insulins could be insulin glargin, insulin detemir or NPH (neutral protamin hagedorn) insulin with duration of action up to 24 h. This antidiabetic therapy has to be unchanged for at least 12 weeks prior to Visit 3 (randomisation).
- •3. HbA1c =7.0 % and <10.0 % at Visit 1
- •4. Age > 18 years at Visit 1
- •5. BMI < 45 kg/m2 (Body Mass Index) at Visit 1
- •6. Signed and dated written informed consent by date of Visit 1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Uncontrolled fasting hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after fast of at least 6 hours during placebo run-in, confirmed by a second measurement on a following day.
- •2. Myocardial infarction, stroke or TIA within 3 months prior to informed consent.
- •3. Impaired hepatic function at Visit 1.
- •4. Gastric bypass surgery.
- •5. Medical history of cancer (except for basal cell carcinoma) with respective treatment in the last 5 years prior to screening.
- •6. Known hypersensitivity or allergy to the investigational product or its recipients.
- •7. Any contraindications to metformin according to the local label for those patients that enter the study with metformin therapy.
- •8. Any contraindications to Pioglitazone according to the local label for those patients that enter the study with pioglitazone therapy.
- •9. Treatment with rosiglitazone, sulfonylurea, GLP-1 analogues or DPP-IV inhibitors within 3 months prior to informed consent.
- •10. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) 3 months prior to informed consent.
- •11. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation.
- •12. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
- •13. Participation in another trial with an investigational drug within 2 months prior to informed consent.
- •14. Pre-menopausal women (last menstruation < 1 year prior to informed consent) who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control
研究者
相似试验
进行中（未招募）
不适用
A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat ® inhaler (5 µg/day) over 48 weeks as add-on controller therapy on top of usual care in patients with severe persistent asthma - TinA in severe asthma 2Patients with severe persistent asthma who are still symptomatic despite being treated with high-dose inhaled corticosteroids and long-acting beta2-agonists. Additional asthma treatments are allowed including systemic corticosteroids at stable doses (5mg/day) and others (like montelukast, omalizumab, etc.).MedDRA version: 9.1Level: LLTClassification code 10049106Term: Asthma chronicEUCTR2008-001414-25-GBBoehringer Ingelheim Limited400
进行中（未招募）
不适用
A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat ® inhaler (5 µg/day) over 48 weeks as add-on controller therapy on top of usual care in patients with severe persistent asthmaPatients with severe persistent asthma who are still symptomatic despite being treated with high-dose inhaled corticosteroids and long-acting beta2-agonists. Additional asthma treatments are allowed including systemic corticosteroids at stable doses (5mg/day) and others (like montelukast, omalizumab, etc.).MedDRA version: 9.1Level: LLTClassification code 10049106Term: Asthma chronicEUCTR2008-001413-14-NLBoehringer Ingelheim300
进行中（未招募）
1 期
A Phase III randomised, double-blind, placebo-controlled, parallel group efficacy and safety study of Linagliptin (5 mg), administered orally once daily for at least 52 weeks in type 2 diabetic patients in combination with basal insulin therapyEstudio de fase III, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y seguridad de linagliptina (5 mg), administrada por vía oral una vez al día durante al menos 52 semanas en pacientes con diabetes tipo 2 en combinación con insulina como tratamiento de baseType 2 diabetes pretreated with basal Insulin therapy - Pacientes con diabetes tipo 2 con terapia basal de insulinaMedDRA version: 9.1Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitusMedDRA version: 9.1Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependentMedDRA version: 9.1Level: LLTClassification code 10029505Term: Non-insulin-dependent diabetes mellitusMedDRA version: 9.1Level: LLTClassification code 10053247Term: Insulin-requiring type 2 diabetes mellitusEUCTR2008-008296-33-ESBoehringer Ingelheim España S.A.1,200
进行中（未招募）
不适用
A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat ® inhaler (5 µg/day) over 48 weeks as add-on controller therapy on top of usual care in patients with severe persistent asthmaPatients with severe persistent asthma who are still symptomatic despite being treated with high-dose inhaled corticosteroids and long-acting beta2-agonists. Additional asthma treatments are allowed including systemic corticosteroids at stable doses (5mg/day) and others (like montelukast, omalizumab, etc.).MedDRA version: 9.1Level: LLTClassification code 10049106Term: Asthma chronicEUCTR2008-001413-14-DEBoehringer Ingelheim Pharma GmbH & Co. KG300
进行中（未招募）
不适用
A Phase III randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat ® inhaler (5 µg/day) over 48 weeks as add-on controller therapy on top of usual care in patients with severe persistent asthma - TinA in severe asthma 1Patients with severe persistent asthma who are still symptomatic despite being treated with high-dose inhaled corticosteroids and long-acting beta2-agonists. Additional asthma treatments are allowed including systemic corticosteroids at stable doses (5mg/day) and others (like montelukast, omalizumab, etc.).MedDRA version: 9.1Level: LLTClassification code 10049106Term: Asthma chronicEUCTR2008-001413-14-GBBoehringer Ingelheim Limited400