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NCT01778049 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01778049
Other study ID # 1275.10
Secondary ID 2012-002271-34
Status Completed
Phase Phase 3
First received January 24, 2013
Last updated April 1, 2015
Start date January 2013
Est. completion date March 2015

Study information
Verified date April 2015
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia MedicaAustralia: Dept of Health and Ageing Therapeutic Goods AdminCanada: Canadian Institutes of Health ResearchGermany: Federal Institute for Drugs and Medical DevicesItaly: Ethics CommitteePortugal: National Pharmacy and Medicines InstituteRussia: Pharmacological Committee, Ministry of HealthSpain: Spanish Agency of MedicinesUkraine: State Pharmacological Center - Ministry of HealthUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 708
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• BI 10773
Empagliflozin active
• BI 10773 Placebo
Empagliflozin placebo
• BI 10773 / BI 1356
Empagliflozin / Linagliptin 25/5 mg Dose FDC active
• BI 10773
Empagliflozin active
• BI 10773 / BI 1356
Empagliflozin / Linagliptin 10/5 mg Dose FDC active
• BI 10773 / BI 1356 Placebo
Empagliflozin / Linagliptin 10/5 mg Dose placebo FDC
• BI 10773
Empagliflozin active
• BI 10773
Empagliflozin active
• BI 10773
Empagliflozin active
• BI 10773 / BI 1356 Placebo
Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
• BI 10773 Placebo
Empagliflozin placebo
• BI 10773 / BI 1356 Placebo
Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo
• BI 10773
Empagliflozin active
• BI 10773 / BI 1356 Placebo
Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo

Locations
Country Name City State
Argentina 1275.10.54005 Boehringer Ingelheim Investigational Site Caba
Argentina 1275.10.54012 Boehringer Ingelheim Investigational Site Caba
Argentina 1275.10.54002 Boehringer Ingelheim Investigational Site Capital Federal
Argentina 1275.10.54007 Boehringer Ingelheim Investigational Site Capital Federal
Argentina 1275.10.54013 Boehringer Ingelheim Investigational Site Capital Federal
Argentina 1275.10.54006 Boehringer Ingelheim Investigational Site Cordoba
Argentina 1275.10.54008 Boehringer Ingelheim Investigational Site Cordoba
Argentina 1275.10.54011 Boehringer Ingelheim Investigational Site Córdoba
Argentina 1275.10.54003 Boehringer Ingelheim Investigational Site Godoy Cruz, Mendoza
Argentina 1275.10.54009 Boehringer Ingelheim Investigational Site Mar del Plata
Argentina 1275.10.54004 Boehringer Ingelheim Investigational Site Salta
Argentina 1275.10.54001 Boehringer Ingelheim Investigational Site San Isidro
Argentina 1275.10.54010 Boehringer Ingelheim Investigational Site Zarate
Australia 1275.10.61008 Boehringer Ingelheim Investigational Site Cardiff New South Wales
Australia 1275.10.61002 Boehringer Ingelheim Investigational Site East Ringwood Victoria
Australia 1275.10.61001 Boehringer Ingelheim Investigational Site Heidelberg Heights Victoria
Australia 1275.10.61009 Boehringer Ingelheim Investigational Site Mirrabooka Western Australia
Canada 1275.10.02013 Boehringer Ingelheim Investigational Site Burlington Ontario
Canada 1275.10.02003 Boehringer Ingelheim Investigational Site Chilliwack British Columbia
Canada 1275.10.02009 Boehringer Ingelheim Investigational Site Coquitlam British Columbia
Canada 1275.10.02011 Boehringer Ingelheim Investigational Site Drummondville Quebec
Canada 1275.10.02004 Boehringer Ingelheim Investigational Site Edmonton Alberta
Canada 1275.10.02005 Boehringer Ingelheim Investigational Site Moncton New Brunswick
Canada 1275.10.02010 Boehringer Ingelheim Investigational Site Montreal Quebec
Canada 1275.10.02001 Boehringer Ingelheim Investigational Site Red Deer Alberta
Canada 1275.10.02002 Boehringer Ingelheim Investigational Site Strathroy Ontario
Canada 1275.10.02007 Boehringer Ingelheim Investigational Site Sudbury Ontario
Canada 1275.10.02012 Boehringer Ingelheim Investigational Site Vancouver British Columbia
Canada 1275.10.02006 Boehringer Ingelheim Investigational Site Winnipeg Manitoba
Canada 1275.10.02008 Boehringer Ingelheim Investigational Site Winnipeg Manitoba
El Salvador 1275.10.34014 Boehringer Ingelheim Investigational Site Ávila
Germany 1275.10.49007 Boehringer Ingelheim Investigational Site Asslar
Germany 1275.10.49014 Boehringer Ingelheim Investigational Site Berlin
Germany 1275.10.49016 Boehringer Ingelheim Investigational Site Elsterwerda
Germany 1275.10.49012 Boehringer Ingelheim Investigational Site Hamburg
Germany 1275.10.49005 Boehringer Ingelheim Investigational Site Hatten
Germany 1275.10.49008 Boehringer Ingelheim Investigational Site Kiel Kronshagen
Germany 1275.10.49004 Boehringer Ingelheim Investigational Site Köln
Germany 1275.10.49010 Boehringer Ingelheim Investigational Site Lübeck
Germany 1275.10.49003 Boehringer Ingelheim Investigational Site Münster
Germany 1275.10.49006 Boehringer Ingelheim Investigational Site Pirna
Germany 1275.10.49013 Boehringer Ingelheim Investigational Site St. Ingbert/Oberwürzbach
Germany 1275.10.49001 Boehringer Ingelheim Investigational Site Unterschneidheim
Germany 1275.10.49015 Boehringer Ingelheim Investigational Site Wangen
Italy 1275.10.39005 Boehringer Ingelheim Investigational Site Ancona
Italy 1275.10.39006 Boehringer Ingelheim Investigational Site Catania
Italy 1275.10.39009 Boehringer Ingelheim Investigational Site Catania
Italy 1275.10.39014 Boehringer Ingelheim Investigational Site Catania
Italy 1275.10.39007 Boehringer Ingelheim Investigational Site Latina
Italy 1275.10.39012 Boehringer Ingelheim Investigational Site Milano
Italy 1275.10.39013 Boehringer Ingelheim Investigational Site Milano
Italy 1275.10.39015 Boehringer Ingelheim Investigational Site Olbia (OT)
Italy 1275.10.39016 Boehringer Ingelheim Investigational Site Orbassano (TO)
Italy 1275.10.39004 Boehringer Ingelheim Investigational Site Palermo
Italy 1275.10.39003 Boehringer Ingelheim Investigational Site Pistoia
Italy 1275.10.39008 Boehringer Ingelheim Investigational Site Roma
Italy 1275.10.39001 Boehringer Ingelheim Investigational Site Sesto San Giovanni (MI)
Italy 1275.10.39010 Boehringer Ingelheim Investigational Site Siena
Italy 1275.10.39011 Boehringer Ingelheim Investigational Site Terni
Portugal 1275.10.35104 Boehringer Ingelheim Investigational Site Cantanhede
Portugal 1275.10.35112 Boehringer Ingelheim Investigational Site Porto
Portugal 1275.10.35103 Boehringer Ingelheim Investigational Site Sandim
Portugal 1275.10.35105 Boehringer Ingelheim Investigational Site Tornada
Portugal 1275.10.35108 Boehringer Ingelheim Investigational Site Valadares
Portugal 1275.10.35101 Boehringer Ingelheim Investigational Site Vila Nova de Gaia
Russian Federation 1275.10.07004 Boehringer Ingelheim Investigational Site Chelyabinsk
Russian Federation 1275.10.07006 Boehringer Ingelheim Investigational Site Saint-Petersburg
Russian Federation 1275.10.07001 Boehringer Ingelheim Investigational Site Saratov
Russian Federation 1275.10.07005 Boehringer Ingelheim Investigational Site Saratov
Russian Federation 1275.10.07003 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 1275.10.07002 Boehringer Ingelheim Investigational Site Yaroslavl
Spain 1275.10.34003 Boehringer Ingelheim Investigational Site Barcelona
Spain 1275.10.34004 Boehringer Ingelheim Investigational Site Canet de Mar
Spain 1275.10.34008 Boehringer Ingelheim Investigational Site Centelles
Spain 1275.10.34009 Boehringer Ingelheim Investigational Site L'Hospitalet de Llobregat (Barcelona)
Spain 1275.10.34012 Boehringer Ingelheim Investigational Site La Roca del Vallès
Spain 1275.10.34006 Boehringer Ingelheim Investigational Site Madrid
Spain 1275.10.34010 Boehringer Ingelheim Investigational Site Malaga
Spain 1275.10.34001 Boehringer Ingelheim Investigational Site Málaga
Spain 1275.10.34011 Boehringer Ingelheim Investigational Site Mataró
Spain 1275.10.34013 Boehringer Ingelheim Investigational Site Pineda de Mar
Spain 1275.10.34002 Boehringer Ingelheim Investigational Site Sabadell
Spain 1275.10.34005 Boehringer Ingelheim Investigational Site Tarragona
Ukraine 1275.10.38006 Boehringer Ingelheim Investigational Site Chernivtsi
Ukraine 1275.10.38007 Boehringer Ingelheim Investigational Site Dnipropetrovs'k
Ukraine 1275.10.38002 Boehringer Ingelheim Investigational Site Kiev
Ukraine 1275.10.38003 Boehringer Ingelheim Investigational Site Kiev
Ukraine 1275.10.38004 Boehringer Ingelheim Investigational Site Lviv
Ukraine 1275.10.38001 Boehringer Ingelheim Investigational Site Vinnitsa
Ukraine 1275.10.38005 Boehringer Ingelheim Investigational Site Zhytomyr
United States 1275.10.01012 Boehringer Ingelheim Investigational Site Avon Indiana
United States 1275.10.01005 Boehringer Ingelheim Investigational Site Bismarck North Dakota
United States 1275.10.01019 Boehringer Ingelheim Investigational Site Chino California
United States 1275.10.01017 Boehringer Ingelheim Investigational Site Conyers Georgia
United States 1275.10.01018 Boehringer Ingelheim Investigational Site Draper Utah
United States 1275.10.01010 Boehringer Ingelheim Investigational Site Elkton Maryland
United States 1275.10.01008 Boehringer Ingelheim Investigational Site Huntington Beach California
United States 1275.10.01011 Boehringer Ingelheim Investigational Site Miami Florida
United States 1275.10.01013 Boehringer Ingelheim Investigational Site Muncie Indiana
United States 1275.10.01014 Boehringer Ingelheim Investigational Site North Richland Hills Texas
United States 1275.10.01020 Boehringer Ingelheim Investigational Site Oklahoma City Oklahoma
United States 1275.10.01009 Boehringer Ingelheim Investigational Site Orlando Florida
United States 1275.10.01023 Boehringer Ingelheim Investigational Site Oviedo Florida
United States 1275.10.01022 Boehringer Ingelheim Investigational Site Pittsburgh Pennsylvania
United States 1275.10.01015 Boehringer Ingelheim Investigational Site Richmond Virginia
United States 1275.10.01007 Boehringer Ingelheim Investigational Site Salisbury North Carolina
United States 1275.10.01003 Boehringer Ingelheim Investigational Site San Diego California
United States 1275.10.01024 Boehringer Ingelheim Investigational Site San Diego California
United States 1275.10.01016 Boehringer Ingelheim Investigational Site Snellville Georgia
United States 1275.10.01001 Boehringer Ingelheim Investigational Site Stevensville Michigan
United States 1275.10.01002 Boehringer Ingelheim Investigational Site Sylmar California
United States 1275.10.01006 Boehringer Ingelheim Investigational Site Tamarac Florida
United States 1275.10.01021 Boehringer Ingelheim Investigational Site Union South Carolina
United States 1275.10.01025 Boehringer Ingelheim Investigational Site Virginia Beach Virginia

Sponsors (2)
Lead Sponsor Collaborator
Boehringer Ingelheim Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  El Salvador,  Germany,  Italy,  Portugal,  Russian Federation,  Spain,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of HbA1c after 24 weeks of treatment (at week 24 or Visit 9) from baseline (Visit 5) 24 weeks No
Secondary Fasting plasma glucose (FPG) change from baseline (Visit 5) at 24 weeks (or Visit 9) 24 weeks No
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