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San Diego, California

  • Diabetes Mellitus, Type 2

Purpose:

The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.


Criteria:

Inclusion criteria: 1. Signed and dated ICF (Informed Consent Form) 2. Male or female on diet and exercise regime and on stable background metformin > or equal to 1500 mg or maximun dose according to local label 3. HBA1c (Glicoslated Hemoglobin) > or equal to 8% and < or equal to 10.5 % at Visit 1 4. HbA1c > or equal to 7 and < or equal to 10.5 at Visit 4 5. Age > or equal to 18 years 6. BMI (Body Mass Index) < or equal to 45 Exclusion criteria: 1. Uncontrolled hyperglycemia during open label period and placebo add on "run-in" period 2. Use of any other antidiabetic 3. Renal function below 60 ml/min/1.73 m2 4. Antiobesity drugs or aggresive diets 5. Gastorintestinal surgeries 6. Current systemic steroids or uncontrolled endocrine disorders other than Diabetes Type 2 7. Acute coronary syndrome and stroke within 3 months of informed consent 8. Known allergies to DPP-IV (Dypeptidil Peptidase IV) or SGLT-2 (Sodium Glucose Transporter 2) inhibitors


NCT ID:

NCT01778049


Primary Contact:

Study Chair
Boehringer Ingelheim
Boehringer Ingelheim


Backup Contact:

N/A


Location Contact:

San Diego, California
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: July 26, 2021

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