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

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: BI 10773

Drug: BI 10773 Placebo

Drug: BI 10773 / BI 1356 Placebo

Drug: BI 10773 / BI 1356

Study type

Interventional

Funder types

Industry

Identifiers

NCT01778049

1275.10

2012-002271-34 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

708 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed and dated ICF (Informed Consent Form)
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
HBA1c (Glicoslated Hemoglobin) > or equal to 8% and < or equal to 10.5 % at Visit 1
HbA1c > or equal to 7 and < or equal to 10.5 at Visit 4
Age > or equal to 18 years
BMI (Body Mass Index) < or equal to 45

Exclusion criteria

Uncontrolled hyperglycemia during open label period and placebo add on "run-in" period
Use of any other antidiabetic
Renal function below 60 ml/min/1.73 m2
Antiobesity drugs or aggresive diets
Gastorintestinal surgeries
Current systemic steroids or uncontrolled endocrine disorders other than Diabetes Type 2
Acute coronary syndrome and stroke within 3 months of informed consent
Known allergies to DPP-IV (Dypeptidil Peptidase IV) or SGLT-2 (Sodium Glucose Transporter 2) inhibitors

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

708 participants in 8 patient groups

Empagliflozin 10 mg dose

Experimental group

Description:

Empagliflozin open label treatment period

Treatment:

Drug: BI 10773

Placebo add on 10 mg dose

Experimental group

Description:

Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo add on run-in

Treatment:

Drug: BI 10773 / BI 1356 Placebo

Drug: BI 10773

Drug: BI 10773 / BI 1356 Placebo

Drug: BI 10773

Empagliflozin/Linagliptin 25/5 mg Dose

Experimental group

Description:

Empagliflozin / Linagliptin 25/5 mg Dose FDC active

Treatment:

Drug: BI 10773 Placebo

Drug: BI 10773 / BI 1356

Drug: BI 10773 Placebo

Empagliflozin/Linagliptin 10/5 mg Dose.

Experimental group

Description:

Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo

Treatment:

Drug: BI 10773 / BI 1356 Placebo

Drug: BI 10773

Drug: BI 10773 / BI 1356 Placebo

Drug: BI 10773

Empagliflozin/Linagliptin 10/5 mg Dose

Experimental group

Description:

Empagliflozin / Linagliptin 10/5 mg Dose FDC active

Treatment:

Drug: BI 10773 Placebo

Drug: BI 10773 / BI 1356

Drug: BI 10773 Placebo

Empagliflozin 25 mg dose

Experimental group

Description:

Empagliflozin open label treatment period

Treatment:

Drug: BI 10773

Empagliflozin/Linagliptin 25/5 mg Dose.

Experimental group

Description:

Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo

Treatment:

Drug: BI 10773 / BI 1356 Placebo

Drug: BI 10773

Drug: BI 10773 / BI 1356 Placebo

Drug: BI 10773

Placebo add on 25 mg dose

Experimental group

Description:

Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo add on run-in

Treatment:

Drug: BI 10773 / BI 1356 Placebo

Drug: BI 10773

Drug: BI 10773 / BI 1356 Placebo

Drug: BI 10773

Trial contacts and locations

114

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