Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Collaborator: Eli Lilly and Company
• Treatments: Empagliflozin; Linagliptin; Metformin

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