Linagliptin Add-on to Insulin Background Therapy

NCT ID: NCT02897349

Last Updated: 2020-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-01-18

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

linagliptin

Group Type: EXPERIMENTAL

linagliptin

Intervention Type: DRUG

background therapy

Intervention Type: DRUG

insulin with or without metformin

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

background therapy

Intervention Type: DRUG

insulin with or without metformin

Interventions

placebo

Intervention Type: DRUG

linagliptin

Intervention Type: DRUG

background therapy

insulin with or without metformin

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

China-Japan Friendship Hospital

Beijing, , China

Beijing Tongren 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, , China

Countries

China

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

1218.102

Identifier Type: -

Identifier Source: org_study_id