A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 1356 (5 mg) as Monotherapy or in Combination With Other Antidiabetic Medications in Type 2 Diabetic Patients.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,122
- 试验地点
- 232
- 主要终点
- Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events
研究概览
简要总结
The objective of the current study is to investigate the safety and tolerability of BI 1356 (5 mg / once daily) given for 78 weeks in different modalities of treatment.
The treatment modalities are determined by the treatment in the blinded trial in which every patient was included previously as BI 1356 in monotherapy (patients in 1218.16 trial), BI 1356 in combination with pioglitazone (patients in 1218.15 trial), BI 1356 added to metformin background (patients in 1218.17 trial) or BI 1356 added to a background therapy of metformin in combination with a sulphonylurea (patients in 1218.18 study)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
linagliptin 5 mg
open label
干预措施: linagliptine 5 mg (Drug)
linagliptin 5 mg and pioglitazone 30 mg
open label
干预措施: linagliptine 5 mg and pioglitazone 30 mg (Drug)
结局指标
主要结局
Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events
时间窗: 78 weeks
Patients reported with cardiac and cerebrovascular events qualified for adjudication by the Clinical Event Committee (CEC)
Number of Patients With Abnormalities in Vital Signs
时间窗: 78 weeks
Vital sign abnormalities (any abnormalities found during PE or ECG are reported with adverse events)
Number of Patients With Abnormalities in Haematology: Eosinophils
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 10%.
Number of Patients With Abnormalities in Haematology: Haemoglobin
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 11.5 g/dL for male and as a value less than or equal to 9.5 g/dL for female patients.
Frequency of Patients With Adverse Events (AEs)
时间窗: 78 weeks
This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.
Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events
时间窗: 78 weeks
Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)
时间窗: 78 weeks
As significant adverse events are considered: renal Aes (SMQ 'acute renal failure'), hypersensitivity reactions ('anaphylactic reactions' and 'angioedema'), hepatic Aes ('hepatitis, non-infectious', 'hepatic failure, fibrosis, cirrhosis and other liver damage-related conditions', 'liver-related investigations, signs and symptoms', 'cholestasis and jaundice of hepatic origin'), severe cutaneous adverse reactions ('severe cutaneous adverse reaction'), pancreatitis ('acute pancreatitis', 'chronic pancreatitis'').
Number of Patients With Abnormalities in Haematology: Haematocrit
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 32%.
Number of Patients With Abnormalities in Haematology: Red Blood Cell Count
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 \* 10\^12/L.
Number of Patients With Abnormalities in Haematology: White Blood Cell Count
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 \* 10\^9/L (decrease) or a value greater than 20.1 \* 10\^9/L (increase).
Number of Patients With Abnormalities in Haematology: Platelets
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as value less than or equal to 75 \* 10\^9/L (decrease) or a value greater than or equal to 700 \* 10\^9/L (increase).
Number of Patients With Abnormalities in Clinical Chemistry: Potassium
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 mmol/L (decrease) or a value greater than 5.8 mmol/L (increase).
Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.
Number of Patients With Abnormalities in Clinical Chemistry: Calcium
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 1.8 mmol/L (decrease) or a value greater than 3 mmol/L (increase).
Number of Patients With Abnormalities in Clinical Chemistry: Alanine Transaminase (ALT)
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
Number of Patients With Abnormalities in Clinical Chemistry: Bilirubin
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 mg/dL.
Number of Patients With Abnormalities in Clinical Chemistry: Albumin
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 2.5 g/dL.
Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 11 mg/dL for male and as a value greater than 10 mg/dL for female patients.
Number of Patients With Abnormalities in Clinical Chemistry: γ-Glutamyl-transferase (GGT)
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH)
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
Number of Patients With Abnormalities in Clinical Chemistry: Amylase
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 1.5 times the upper limit of normal (ULN).
Number of Patients With Abnormalities in Clinical Chemistry: Creatinine
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 1.5 mg/dL.
Number of Patients With Abnormalities in Clinical Chemistry: Sodium
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 130 mmol/L (decrease) or a value greater than 160 mmol/L (increase).
Number of Patients With Abnormalities in Clinical Chemistry: Glucose
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 54 mg/dL.
Number of Patients With Abnormalities in Clinical Chemistry: Cholesterol
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.
Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST)
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
Number of Patients With Abnormalities in Clinical Chemistry: Phosphate
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 0.7 mmol/L (decrease) or a value greater than 1.7 mmol/L (increase).
Number of Patients With Abnormalities in Clinical Chemistry: Alkaline Phosphatase (AP)
时间窗: 78 weeks
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 times the ULN.
次要结局
- Change in HbA1c From Baseline to Week 6(Baseline and week 6)
- Change in HbA1c From Baseline to Week 18(Baseline and week 18)
- Change in HbA1c From Baseline to Week 30(Baseline and week 30)
- Change in HbA1c From Baseline to Week 42(Baseline and week 42)
- Change in HbA1c From Baseline to Week 54(Baseline and week 54)
- Change in HbA1c From Baseline to Week 66(Baseline and week 66)
- Change in HbA1c From Baseline to Week 78(Baseline and week 78)
- Number of Patients With HbA1c<7.0% Over Time(78 weeks)
- Number of Patients With HbA1c<6.5% Over Time(78 weeks)
- Number of Patients With Lowered HbA1c by at Least 0.5% Over Time(78 weeks)
- Change in FPG From Baseline to Week 6(Baseline and week 6)
- Change in FPG From Baseline to Week 18(Baseline and week 18)
- Change in FPG From Baseline to Week 30(Baseline and week 30)
- Change in FPG From Baseline to Week 42(Baseline and week 42)
- Change in FPG From Baseline to Week 54(Baseline and week 54)
- Change in FPG From Baseline to Week 66(Baseline and week 66)
- Change in FPG From Baseline to Week 78(Baseline and week 78)