EUCTR2012-002270-31-NO
Active, not recruiting
Phase 1
A phase III, randomised, double-blind, parallel group, 24 week study to evaluate efficacy and safety of once daily empagliflozin 10 mg and 25 mg compared to placebo, all administered as oral fixed dose combinations with linagliptin 5 mg, in patients with type 2 diabetes mellitus and insufficient glycaemic control after 16 weeks treatment with linagliptin 5 mg once daily on metformin background therapy.
DrugsTrajenta
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 1134
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Diagnosis of type 2 diabetes mellitus prior to informed consent
- •2\.Male and female patients on diet and exercise regimen who are pre\-treated with an unchanged dose of immediate release metformin for at least 12 weeks prior to screening. Patients should be on \=1500 mg/day of metformin or maximum tolerated dose (must be documented) or maximum dose as per local label
- •3\.HbA1c \= 8\.0% and \= 10\.5% at Visit 1 for entering the 16 week treatment period.
- •4\.HbA1c \= 7\.0% and \= 10\.5% at Visit 4 for randomisation into the 24 week double\-blind treatment period.
- •5\.Age \= 18 years at screening
- •6\.Body Mass Index (BMI) \= 45 kg/m2 at Visit 1 (screening)
- •7\.Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •1\.Uncontrolled hyperglycemia with a glucose level \>270 mg/dl (\>15 mmol/L) after an overnight fast during the open label treatment period (from Visit 2 to Visit 4\) and placebo add on run\-in period (Visit 4 to Visit 5\) and confirmed by a second measurement (not on the same day and done either at the central or at local laboratory).
- •2\.Any other antidiabetic drug within 12 weeks prior to Visit 2 (except metformin background therapy as defined via inclusion criterion 2\). Use of other antidiabetic treatment (except study drug and metformin background medication) prior to randomization (Visit 5\).
- •3\.Acute coronary syndrome (non\-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent
- •4\.Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening, linagliptin treatment and/or placebo add on run\-in” period
- •5\.Impaired renal function, defined as eGFR \<60 ml/min/1\.73m2 (MDRD formula) as determined during screening, linagliptin treatment and/or placebo add on run\-in” period
- •6\.Known hereditary galactose intolerance
- •7\.Known contradications to metformin or linagliptin according to the local label
- •8\.Any previous (within the past two years) or planned bariatric surgery (or any other weight loss surgery) or other gastrointestinal surgery that induce chronic malabsorption
- •9\.Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
- •10\.Known blood dyscrasias or any disorders causing hemolysis or unstable red blood cell count (e.g. malaria, babesiosis, hemolytic anemia) due to the short lifespan of the RBC and its impact on HbA1c.
Outcomes
Primary Outcomes
Not specified
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