EUCTR2012-002271-34-ES
Active, not recruiting
Not Applicable
A phase III, randomized, double-blind, parallel group study to evaluate the efficacy and safety of linagliptin 5 mg compared to placebo, administered as oral fixed dose combination with empagliflozin 10 mg or 25 mg, in patients with type 2 diabetes mellitus and insufficient glycaemic control after 16 weeks of treatment with empagliflozin 10 mg or 25 mg on metformin background therapy.
Boehringer Ingelheim España, S.A0 sites690 target enrollmentOctober 29, 2012
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Boehringer Ingelheim España, S.A
- Enrollment
- 690
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients treated with metformin for at least 12 weeks
- •HbA1c ? 8\.0% (64 mmol/mol) and ? 10\.5% (91 mmol/mol) at Visit 1 for the 16 week open label treatment period.
- •HbA1c ? 7\.0% (53 mmol/mol) and ? 10\.5 % (91 mmol/mol) at Visit 4 for the 24 week double\-blind treatment period.
- •Body Mass Index (BMI) ?45 kg/m2 at Visit 1 (screening)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 517
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 173
Exclusion Criteria
- •Uncontrolled hyperglycaemia with a glucose level \>270 mg/dl (\>15\.0 mmol/L) after an overnight fast during the open label period (from Visit 2 to Visit 4\) and placebo add on run\-in period (Visit 4 to Visit 5\).
- •Any other antidiabetic drug within 12 weeks prior to Visit 2 randomization (except metformin background therapy)
- •Acute coronary syndrome (non\-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent
- •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) based on Visit 1 and Visit 4 laboratory parameters.
- •Impaired renal function, defined as eGFR \<60 ml/min/1\.73 m2 (MDRD formula) as determined during screening (Visit 1\) or placebo add on run\-in (Visit 4\)
- •Known blood dyscrasias or any disorders causing haemolysis or unstable red blood cell count (e.g. malaria, babesiosis, haemolytic anaemia) due to the short lifespan of the RBC and its impact on HbA1c.
- •Treatment with anti\-obesity drugs (e.g. sibutramine, orlistat) within 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 (other than inhaled or topical steroids) at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other documented uncontrolled endocrine disorder except T2DM.
- •Pre\-menopausal women (last menstruation ?1 year prior to informed consent) who are nursing or pregnant.
Outcomes
Primary Outcomes
Not specified
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