Clinical Trials List
2011-09-01 - 2018-12-31
Phase III
Terminated16
ICD-10E11.9
Type 2 diabetes mellitus without complications
ICD-10E13.9
Other specified diabetes mellitus without complications
ICD-9250.00
Diabetes mellitus without mention of complication, Type II [non-insulin dependent type][NIDDM type] [ adult-onset type] or unspecified type, not stated as uncontrolled
A multicentre, international, randomised, parallel group, double blind study to evaluate Cardiovascular safety of linagliptin versus glimepiride in patients with type 2 diabetes mellitus at high cardiovascular risk.
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Trial Applicant
Boehringer Ingelheim
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Sponsor
Boehringer Ingelheim
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 林時逸 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 林幸榮 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 劉俊廷 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 陳志鴻 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 洪惠風 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- JYH-MING JIMMY JUANG Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chung-Ze Wu Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 任勗龍 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 蘇景傑 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 李明蒼 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 顏學偉 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 夏建勳 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 蘇正煌, 郭任遠, 洪大川, 劉俊傑, 陳俊延, 李應湘, 李俊偉, 林書毅, 程崇偉 Division of Cardiovascular Diseases
- 蘇正煌 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Shih-Sheng Chang Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 蘇正煌, 郭任遠, 洪大川, 劉俊傑, 陳俊延, 李應湘, 李俊偉, 林書毅, 程崇偉 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
adjudicated components of the primary composite endpoint: CV death (including fatal
stroke and fatal MI), non-fatal MI, non-fatal stroke and hospitalisation for unstable
angina pectoris.
Inclution Criteria
2) a high risk of CV events prior to informed consent
1) Insufficient glycaemic control (at Visit 1a) defined as:
a) HbA1c 6.5 - 8.5% (48 - 69 mmol/mol) while patient is treatment naïve or treated
with:
- metformin monotherapy, or
- alpha-glucosidase inhibitor monotherapy (e.g. acarbose, voglibose), or
- metformin + alpha-glucosidase inhibitor (e.g. acarbose, voglibose), or
b) HbA1c 6.5 - 7.5% (48 - 58 mmol/mol) while patient is treated with
- sulphonylurea (SU) monotherapy, or
- glinide monotherapy (e.g. repaglinide, nateglinide), or
- metformin + sulphonylurea (combination maximal up to 5 years), or
- metformin + glinide (combination maximal up to 5 years)
2) High risk of CV events defined as any one (or more) of A), B), C) or D):
A) Previous Vascular Disease:
- Myocardial infarction (> 6 weeks prior to informed consent)
- Documented coronary artery disease (≥50% luminal diameter narrowing
of left main coronary artery or in at least two major coronary arteries in
angiogram)
- Percutaneous Coronary Intervention (PCI) > 6 weeks prior informed
consent
- Coronary Artery By-pass Grafting (CABG) > 4 years prior to informed
consent or with recurrent angina following surgery
- Ischemic or hemorrhagic stroke (> 3 months prior to informed consent)
- Peripheral occlusive arterial disease (previous limb bypass surgery or
percutaneous transluminal angioplasty; previous limb or foot amputation
due to circulatory insufficiency, angiographic or ultrasound detected
significant vessel stenosis (>50%) of major limb arteries (common iliac
artery, internal iliac artery, external iliac artery, femoral artery, popliteal
artery), history of intermittent claudication, with an ankle: arm blood
pressure ratio < 0.90 on at least one side).
B) Evidence of vascular related end-organ damage:
- Moderately impaired renal function (as defined by modified diet of renal
disease (MDRD) formula) with estimated glomerular filtration rate
[eGFRF]) 30-59 mL/min/1.73 m2
- Random spot urinary albumin:creatinine ratio ≥ 30 μg/mg in two of three
unrelated specimens in previous 12 months prior Visit 1a
- Proliferative retinopathy defined as retinal neovascularisation or previous
retinal laser coagulation therapy.
C) Age ≥ 70 years (at Visit 1a)
D) At least two of the following CV risk factors:
- Type 2 diabetes mellitus duration > 10 years at Visit 1a.
- Systolic blood pressure (SBP) > 140 mmHg (or on at least one blood
pressure lowering treatment at Visit 1a)
- Current daily cigarette smoking
- LDL cholesterol ≥ 135 mg/dL (3.5 mmol/l) (or specific current treatment
for this lipid abnormality) at Visit 1a
3) Body Mass Index (BMI) ≤ 45 kg/m2 at Visit 1a
4) Age ≥ 40 and ≤ 85 years at Visit 1a
5) Signed and dated written informed consent at the latest by the date of Visit 1a, in
accordance with GCP and local legislation
Exclusion Criteria
2) Treatment with other antidiabetic drugs (e.g. rosiglitazone, pioglitazone, GLP-1
analogue/agonists, DPP-IV inhibitors or any insulin) prior to informed consent. Note:
previous short term use of insulin (up to two weeks) is allowed (e.g. during
hospitalisation) if taken at least 8 weeks prior informed consent.
3) Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to
informed consent
4) Uncontrolled hyperglycaemia 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).
5) Active liver disease or impaired hepatic function, defined by serum levels of either
ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal
(ULN) as determined at Visit 1a.
6) Any previous (or planned within next 12 months) bariatric surgery (open or
laparascopic) or intervention (gastric sleeve)
7) Pre-planned coronary artery re-vascularization (PCI, CABG) within next 6 months
8) Known hypersensitivity or allergy to the investigational product or its excipients,
metformin or glimepiride
9) Inappropriateness of glimepiride treatment for renal safety issues according to local
prescribing information
10) Congestive heart failure of NYHA class III or IV
11) Acute or chronic metabolic acidosis (present condition in patient history)
12) Hereditary galactose intolerance
13) Alcohol or drug abuse within the 3 months prior to informed consent that would
interfere with trial participation
14) Current treatment with systemic steroids at time of informed consent or pre-planned
initiation of such therapy. Note: inhaled use of steroids (e.g. for asthma/COPD) is no
exclusion criterion, as this does not cause systemic steroid action.
15) Change in dose of thyroid hormones within 6 weeks prior informed consent
16) Participation in another trial with an investigational drug given within 2 months prior
to informed consent
17) Pre-menopausal women (last menstruation ≤ 1 year prior to informed consent) who:
- are nursing or pregnant,
- or are of child-bearing potential and are not practicing an acceptable method of birth
control (acceptable methods of birth control include tubal ligation, transdermal patch,
intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable
contraceptives and vasectomised partner) or do not plan to continue using acceptable
method of birth control throughout the study and do not agree to submit to periodic
pregnancy testing during participation in the trial.
18) Patients considered unreliable by the investigator concerning the requirements for
follow-up during the study and/or compliance with study drug administration, has a
life expectancy less than 5 years for non-CV causes, or has cancer other than nonmelanoma
skin cancer within last 3 years, or has any other condition than mentioned
which in the opinion of the investigator, would not allow safe participation in the
study.
The Estimated Number of Participants
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Taiwan
200 participants
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Global
9000 participants
