Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of Linagliptin, Administered Orally Once Daily, in Combination With Insulin Therapy for 24 Weeks in Chinese Type 2 Diabetes Mellitus Patients With Insufficient Glycaemic Control
Verified date | March 2020 |
Source | Boehringer Ingelheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the efficacy and safety of linagliptin compared to placebo when added on to insulin therapy alone or in combination with metformin in Chinese patients with type 2 diabetes mellitus with insufficient glycaemic control
Status | Completed |
Enrollment | 206 |
Est. completion date | January 18, 2019 |
Est. primary completion date | January 11, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: - Diagnosis of type 2 diabetes mellitus prior to informed consent. - Chinese male or female patients who are pre-treated with insulin alone or in combination with metformin: - With maximum insulin dose of <= 1 unit/kg/day. Acceptable basal insulins could be insulin glargin, insulin detemir or NPH (neutral protamin hagedorn) insulin with duration of action up to 24 h; acceptable pre-mixed insulins could be preparations with 25/75 or 30/70 ratio, with once or twice daily posology only. The total insulin dose should not be changed by more than 10% of the baseline value within the 12 weeks prior to randomisation (Visit 3). Both human insulin & insulin analogue are accepted. - If the patient is taking metformin, stable dose (at least 1500 mg daily) must be maintained for at least 12 weeks without dose adjustments prior to randomisation (Visit 3). - HbA1c fulfills the following criteria: >= 7.5 % to <= 10.0 % at Visit 1. - Age >= 18 years at Visit 1. - BMI <= 45 kg/m2 (Body Mass Index) at Visit 1. - Women of childbearing potential must be ready and able to use highly effective methods of birth control per ICH (International Conference on Harmonisation) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. - A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. - Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. - Signed and dated written informed consent by date of Visit 1 in accordance with ICH-GCP (Good Clinical Practice) and local legislation Exclusion criteria: - Uncontrolled hyperglycaemic with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day). - Any other antidiabetic drug within 3 months prior to informed consent except those defined as background treatment via inclusion criterion 2. - Acute coronary syndrome (non-STEMI (ST Segment Elevation Myocardial Infarction), STEMI and unstable angina pectoris), stroke or TIA (Transient ischemic attack) within 3 months prior to informed consent. - Indication of liver disease, defined by serum levels of either ALT (Alanine aminotransferase) (SGPT (serum glutamic pyruvate transaminase )), AST (Aspartate aminotransferase) (SGOT (serum glutamic-oxaloacetic transaminase)), or alkaline phosphatase above 3 × upper limit of normal (ULN (upper limit of normal)) as determined during screening and/or run-in phase. - Any contraindications to metformin according to the local label for those patients that enter the study with metformin therapy as provided in ISF (Investigator Site File). - Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption. - Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years. - Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia). - Known hypersensitivity or allergy to the investigational product or its recipients. - Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight. - Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM (Type 2 diabetes mellitus). - Women who are pregnant, nursing, or who plan to become pregnant while in the trial. - Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake in the opinion of the investigator. - Participation in another trial with an investigational drug within 2 months prior to informed consent or previous enrolment in this trial. - Any other clinical condition that would jeopardize patient's safety while participating in this clinical trial in the opinion of the investigator. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Tongren Hospital | Beijing | |
China | China-Japan Friendship Hospital | Beijing | |
China | The General Hospital of Chinese People's Armed Police Forces | Beijing | |
China | First Hospital of Jilin University | Changchun | |
China | No.900 Hospital of PLA Joint Logistics Support Force | Fuzhou | |
China | Third Affiliated Hospital of Guangzhou Medical University | Guangzhou | |
China | The Affiliated Hospital of Guizhou Medical University | Guiyang | |
China | The Affiliated Hospital of Hangzhou Normal University | Hangzhou | |
China | General Hospital of Jinan Military Area | Jinan | |
China | Nanjing First Hospital | Nanjing | |
China | The affiliated hospital of medicalcollege qingdao university | Qingdao | |
China | Centre Hospital of Putuo District, Shanghai | Shanghai | |
China | Shanghai Tenth People's Hospital | Shanghai | |
China | Yangpu Hospital, Tongji University | Shanghai | |
China | Second Hospital Affiliated to Shantou Medical University | Shantou | |
China | Shengjing Hospital of China Medical University | Shengyang | |
China | Siping Central People's Hospital | Siping | |
China | The First Affiliated Hospital of Soochow University | Suzhou | |
China | Nankai University Affiliated Hospital | Tianjin | |
China | The 2nd Hospital of Tianjin Medical University | Tianjin | |
China | Tianjin Medical University General Hospital | Tianjin | |
China | Renmin Hospital of Wuhan University | Wuhan | |
China | First Affiliated Hospital of Xiamen University | Xiamen | |
China | the first people hospital of Yue Yang | Yueyang | |
China | Affiliated Hospital of Jiangsu University | Zhenjiang |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim | Eli Lilly and Company |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment | Percentage change from baseline, that is, [[(HbA1c after 24 weeks of treatment) - (HbA1c at baseline)] / (HbA1c at baseline)] *100%, where baseline refers to the last observation prior to the start of randomised study drug, including the observation prior to the placebo run-in. | Baseline and week 24 | |
Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment | Change from baseline in Fasting plasma glucose (FPG) after 24 weeks of treatment. | Baseline and week 24 | |
Secondary | Change From Baseline in 2-hour (2-h) Postprandial Plasma Glucose (PPG) After 24 Weeks of Treatment | Change from baseline in 2-hour (2-h) postprandial plasma glucose (PPG) after 24 weeks of treatment. | Baseline and week 24 | |
Secondary | Percentage of Participants With HbA1c on Treatment <7.0 Percentage (%) After 24 Weeks of Treatment | Percentage of participants with HbA1c on treatment <7.0 percentage (%) after 24 weeks of treatment. Participants with baseline HbA1c <7.0% were excluded from the analysis. | 24 weeks | |
Secondary | Percentage of Participants With HbA1c on Treatment < 6.5% After 24 Weeks of Treatment | Percentage of participants with HbA1c on treatment < 6.5% after 24 weeks of treatment. Participants with baseline HbA1c <6.5% were excluded from the analysis. | 24 weeks | |
Secondary | Percentage of Participants With HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment | Percentage of participants with HbA1c lowering by at least 0.5% after 24 weeks of treatment. | 24 weeks | |
Secondary | Percentage of Participants With Any Investigator-defined Hypoglycaemic Adverse Event (AE) With Plasma Glucose (PG) =70 mg/dL | Incidence of investigator-reported hypoglycaemic events confirmed by a measured blood glucose =70 mg/dL (=3.9 Millimoles Per Litre (mmol/L)). Severe hypoglycaemic AE = hypoglycaemic event requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions. | 24 weeks | |
Secondary | Percentage of Participants With Any Severe Hypoglycaemic AE | Incidence of severe hypoglycaemic events (requiring active assistance by another person, or fatal). Severe hypoglycaemic AE = hypoglycaemic event requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions. | 24 weeks |
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