Linagliptin Add-on to Insulin Background Therapy

NCT02897349 | Completed Phase 3 Results

• 1 other identifier: 1218.102
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 25

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment

  Baseline and week 24

• Change From Baseline in 2-hour (2-h) Postprandial Plasma Glucose (PPG) After 24 Weeks of Treatment

  Baseline and week 24

• Percentage of Participants With HbA1c on Treatment <7.0 Percentage (%) After 24 Weeks of Treatment

  24 weeks

• Percentage of Participants With HbA1c on Treatment < 6.5% After 24 Weeks of Treatment

  24 weeks

• Percentage of Participants With HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment

  24 weeks

Study Arms (2)

linagliptin

EXPERIMENTAL

Drug: linagliptin; Drug: background therapy

Placebo

PLACEBO COMPARATOR

Drug: placebo; Drug: background therapy

Interventions

placebo DRUG

Placebo

linagliptin DRUG

linagliptin

background therapy DRUG

insulin with or without metformin

Placebo; linagliptin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Eli Lilly and Company: collaborator

Study Sites (25)

China-Japan Friendship Hospital

Beijing, 100029, China

Location

Beijing Tongren Hospital

Beijing, 100730, China

Location

The General Hospital of Chinese People's Armed Police Forces

Beijing, 100854, China

Location

First Hospital of Jilin University

Changchun, 130021, China

Location

No.900 Hospital of PLA Joint Logistics Support Force

Fuzhou, 350025, China

Location

Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510150, China

Location

The Affiliated Hospital of Guizhou Medical University

Guiyang, 550004, China

Location

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, 310015, China

Location

General Hospital of Jinan Military Area

Jinan, 250000, China

Location

Nanjing First Hospital

Nanjing, 210006, China

Location

The affiliated hospital of medicalcollege qingdao university

Qingdao, 266005, China

Location

Centre Hospital of Putuo District, Shanghai

Shanghai, 200062, China

Location

Shanghai Tenth People's Hospital

Shanghai, 200072, China

Location

Yangpu Hospital, Tongji University

Shanghai, 200090, China

Location

Second Hospital Affiliated to Shantou Medical University

Shantou, 515041, China

Location

Shengjing Hospital of China Medical University

Shengyang, 110072, China

Location

Siping Central People's Hospital

Siping, 136000, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, 215006, China

Location

Nankai University Affiliated Hospital

Tianjin, 300000, China

Location

The 2nd Hospital of Tianjin Medical University

Tianjin, 300000, China

Location

Tianjin Medical University General Hospital

Tianjin, 30052, China

Location

Renmin Hospital of Wuhan University

Wuhan, 430060, China

Location

First Affiliated Hospital of Xiamen University

Xiamen, 361003, China

Location

the first people hospital of Yue Yang

Yueyang, 414000, China

Location

Affiliated Hospital of Jiangsu University

Zhenjiang, 212013, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Linagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 13, 2016
• Study Start: September 30, 2016
• Primary Completion: January 11, 2019
• Study Completion: January 18, 2019
• Last Updated: March 25, 2020
• Results First Posted: January 21, 2020

Record last verified: 2020-03

Locations

CN (25)