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

Status:	Completed
Conditions:	Diabetes
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	January 2013
End Date:	March 2015

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 for 24 Weeks, 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

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.

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

We found this trial at

sites

205.452.01012 Boehringer Ingelheim Investigational Site

Conyers, Georgia

from

Conyers, GA