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Diabetes Mellitus, Type 2Phase 3NCT02897349

Linagliptin Add-on to Insulin Background Therapy

A Phase 3 study testing linagliptin and background therapy in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 25 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
linagliptin and background therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
206 participants
Where
25 sitesChina
Study dates
30 Sep 2016to 18 Jan 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

China25 sites

  • China-Japan Friendship Hospital

    Beijing, 100029

  • Beijing Tongren Hospital

    Beijing, 100730

  • The General Hospital of Chinese People's Armed Police Forces

    Beijing, 100854

  • First Hospital of Jilin University

    Changchun, 130021

  • No.900 Hospital of PLA Joint Logistics Support Force

    Fuzhou, 350025

  • Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510150

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, 550004

  • The Affiliated Hospital of Hangzhou Normal University

    Hangzhou, 310015

  • General Hospital of Jinan Military Area

    Jinan, 250000

  • Nanjing First Hospital

    Nanjing, 210006

  • The affiliated hospital of medicalcollege qingdao university

    Qingdao, 266005

  • Centre Hospital of Putuo District, Shanghai

    Shanghai, 200062

  • Shanghai Tenth People's Hospital

    Shanghai, 200072

  • Yangpu Hospital, Tongji University

    Shanghai, 200090

  • Second Hospital Affiliated to Shantou Medical University

    Shantou, 515041

  • Shengjing Hospital of China Medical University

    Shengyang, 110072

  • Siping Central People's Hospital

    Siping, 136000

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215006

  • Nankai University Affiliated Hospital

    Tianjin, 300000

  • The 2nd Hospital of Tianjin Medical University

    Tianjin, 300000

  • Tianjin Medical University General Hospital

    Tianjin, 30052

  • Renmin Hospital of Wuhan University

    Wuhan, 430060

  • First Affiliated Hospital of Xiamen University

    Xiamen, 361003

  • the first people hospital of Yue Yang

    Yueyang, 414000

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, 212013

Other trials in China

About this study

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

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

Being tested
placebo, linagliptin, background therapy
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placeboDrug

  • linagliptinDrug

  • background therapyDrug

    insulin with or without metformin

Study groups in NCT02897349
Study groupRoleWhat they receive
linagliptinExperimentalNot described
Receives: Drug: linagliptin; Drug: background therapy
PlaceboPlacebo comparatorNot described
Receives: Drug: placebo; Drug: background therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and week 24

Secondary outcomes (7)

  1. 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.

    Measured: Baseline and week 24

  2. 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.

    Measured: Baseline and week 24

  3. 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.

    Measured: 24 weeks

  4. 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.

    Measured: 24 weeks

  5. 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.

    Measured: 24 weeks

  6. 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.

    Measured: 24 weeks

  7. 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.

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2016 (estimated)
  2. Study start30 Sep 2016
  3. Primary completion11 Jan 2019
  4. Study completion18 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02897349
Sponsor's protocol ID
1218.102
Status last verified
Mar 2020
First submitted
30 Aug 2016
Last updated
25 Mar 2020

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing linagliptin and background therapy in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 25 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment (time frame: Baseline and week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02897349.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.

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