None listed
Conditions
Interventions
Group 1 Type of group
patient to receive linagliptin 5 mg or glimepiride placebo overencapsulated tablet QD
Group name:Group 2 Type of group
patient to receive glimepiride 1-4 mg or linagliptin placebo tablet QD
Sponsors
Boehringer Ingelheim,
Eligibility
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: • Type 2 diabetes • Elevated glycosylated haemoglobin (HbA1c): 6.5 - 8.5%, inclusive, if treatment naïve or mono-/dual therapy with metformin and/or an alpha-glucosidase inhibitor; 6.5 - 7.5%, inclusive, if treatment with sulphonylurea/glinide in mono- or dual (with metformin OR an alpha-glucosidase inhibitor) therapy) • Pre-existing cardiovascular disease OR specified diabetes end-organ damage OR age => 70 years OR two or more specified cardiovascular risk factor • BMI == 40 and =< 85 years • signed and dated written ICF • stable anti-diabetic background for at least 8 weeks before study start
Exclusion criteria
Exclusion criteria: • Type 1 diabetes • Treatment with other antidiabetic drugs (e.g. rosiglitazone, pioglitazone, Glucagon-like peptide 1 (GLP-1) analogue/agonists, Dipeptidyl-peptidase IV (DPP-IV) inhibitors or any insulin) prior to informed consent (previous short term use of insulin (up to two weeks) is allowed if taken at least 8 weeks prior informed consent) • treatment with any anti-obesity drug less than 3 months before ICF • uncontrolled hyperglycemia • previous or planned bariatric surgery or intervention • current or planned system corticoid treatment • change in thyroid hormones treatment • acute liver disease or impaired hepatic function • pre-planned coronary artery revascularization within 6 months of ICF • known hypersensitivity to any of the components • Inappropriateness of glimepiride treatment for renal safety issues according to local prescribing information • congestive heart failure class III or IV • acute or chronic metabolic acidosis • hereditary galactose intolerance • alcohol or drug abuse • participation in another trail with IMP given 2 months before IMP start • pre-menopausal women who are nursing or pregnant or of child-bearing potential and not willing to use acceptable method of birth control • patients considered reliable by the investigator • acute coronary syndrome =< 6 wks before ICF • stroke or TIA =< 3 months prior to ICF
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Registration of the following events: cardiovascular death (including fatal stroke and fatal myocardial infarction), nonfatal myocardial infarction, nonfatal stroke and hospitalization for unstable angina pectoris. Measure:Time that elapses until the first event of any of the following awarded components of the combined primary assessment criteria: cardiovascular death (including fatal stroke and fatal myocardial infarction), nonfatal myocardial infarction, nonfatal stroke and hospitalization for unstable angina pectoris Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Defined as the proportion of patients who continue to receive treatment at the end of the study and who maintain a glycemic control (HbAic 2% of weight in the final visit (between the visit 6 and the final visit) Measure:Proportion of patients with sustainable treatment Timepoints:During the study ; Outcome name:Defined as the proportion of patients who continue to receive treatment at the end of the study and who maintain a glycemic control (HbA1g 2% weight in the final visit (between visit 6 and the final visit) Measure:Percentage of patients with sustainable treatment and patients who have not gained> 2% weight in the final visit (between visit 6 and the final visit) Timepoints:During the study | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungaria, India, Ireland, Israel, Italy, Japan, Korea South, Malasya, Mexico, Netherlands, New Zealand, Norway, Philippines, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Ukraine, United States
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed