Effects of Empagliflozin + Linagliptin vs Metformin + Insulin Glargine on Renal and Vascular Changes in Type 2 Diabetes

Launched by INSTITUT FÜR PHARMAKOLOGIE UND PRÄVENTIVE MEDIZIN · Apr 21, 2016

Keywords

ClinConnect Summary

Diabetes mellitus, considered at the beginning as a metabolic disorder, mutates into a predominantly vascular disease, once its duration extends over several years or/and when additional cardiovascular (CV) risk factors coexist, in particular arterial hypertension. As a consequence, treatment of type 2 diabetes should focus not only on metabolic control but also on improving the vascular structure and function in the micro- and macrocirculation (1). Glomerular hyperfiltration and hyperperfusion pointing to altered intraglomerular hemodynamics, e.g. reduced preglomerular (i.e. resistance of ...

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Eligibility criteria

• Inclusion Criteria:
• • Type 2 diabetes mellitus, using already metformin (850 or 1000 mg twice daily) for at least 2 months prior to screening visit or type 2 diabetes switched to metformin at least 3 months prior to randomisation visit
• • HbA1c ≥6.5 % if on antidiabetic montherapy or HbA1c ≥ 6.0 if on two antidiabetic drugs - Age of 18 - 75 years
• • Male and female patients (females of child bearing potential must be using adequate contraceptive precautions)
• • Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at screening visit
• • Informed consent (§ 40 Abs. 1 Satz 3 Punkt 3 AMG) has to be given in written form.
• Exclusion Criteria:
• • Any other form of diabetes mellitus than type 2 diabetes mellitus
• • Use of insulin, glitazone, gliptin or SGLT-2 inhibitor within the past 2 months
• • HbA1c \> 10.5% if on antidiabetic monotherapy and \> 9.5% if on two antidiabetic drugs
• • Fasting plasma glucose \> 240 mg/dl
• • Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 6 months prior to study inclusion
• • UACR ≥ 300 mg/g (early morning spot urine)
• • Estimated GFR (eGFR) \< 60 ml/min/1.73m²
• • Uncontrolled arterial hypertension (blood pressure ≥ 180/110 mmHg)
• • Congestive heart failure NYHA stage III and IV
• • Severe disorders of the gastrointestinal tract or other diseases which interfere the pharmacodynamics and pharmacokinetics of study drugs
• • Significant laboratory abnormalities such as serum Glutamate-Oxaloacetate-Transaminase (SGOT) or serum Glutamate-Pyruvate-Transaminase (SGPT) levels more than 3 x above the upper limit of normal range
• • Drug or alcohol abuses
• • Pregnant or breast-feeding patients
• • Use of loop diuretics
• • History of repetitive urogenital infection per year
• • Body mass index \> 40 kg/m²
• • Triglyceride levels \> 1000 mg/dl
• • High density lipoprotein (HDL)-cholesterol levels \< 25 mg/dl
• • Any patient currently receiving chronic (\>30 consecutive days) treatment with an oral corticosteroid
• • Patients being treated for severe auto immune disease e.g. lupus
• • Participation in another clinical study within 30 days prior to visit 1
• • Individuals at risk for poor protocol or medication compliance
• • Subject who do not give written consent, that pseudonymous data will be transferred in line with the duty of documentation and the duty of notification according to § 12 and § 13 GCP-V