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Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

linagliptine 5 mg

linagliptine 5 mg and pioglitazone 30 mg

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 82 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Signed and dated written informed consent in accordance with the GCP and local legislation.
Patients completing the entire treatment period as a double blind trial whether or not they have been treated with rescue medication.

Exclusion criteria:

Patients who meet one or more of the withdrawal criteria of the treatment period of the previous trial.
Pre-menopausal women (last menstruation =< 1 year prior to signing informed consent) who:
- are nursing or pregnant,
- or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, true sexual abstinence (when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of birth control) and vasectomised partners. No exception will be made.
Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation.
Drug abuse which, in the opinion of the investigator, would interfere with trial participation.
Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

linagliptin 5 mg

linagliptin 5 mg and pioglitazone 30 mg

Arm Description

open label

Outcomes

Primary Outcome Measures

Frequency of Patients With Adverse Events (AEs)

This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.

Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events

Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)

As significant adverse events are considered: renal Aes (SMQ 'acute renal failure'), hypersensitivity reactions ('anaphylactic reactions' and 'angioedema'), hepatic Aes ('hepatitis, non-infectious', 'hepatic failure, fibrosis, cirrhosis and other liver damage-related conditions', 'liver-related investigations, signs and symptoms', 'cholestasis and jaundice of hepatic origin'), severe cutaneous adverse reactions ('severe cutaneous adverse reaction'), pancreatitis ('acute pancreatitis', 'chronic pancreatitis'').

Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events

Patients reported with cardiac and cerebrovascular events qualified for adjudication by the Clinical Event Committee (CEC)

Number of Patients With Abnormalities in Vital Signs

Vital sign abnormalities (any abnormalities found during PE or ECG are reported with adverse events)

Number of Patients With Abnormalities in Haematology: Eosinophils

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 10%.

Number of Patients With Abnormalities in Haematology: Haemoglobin

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 11.5 g/dL for male and as a value less than or equal to 9.5 g/dL for female patients.

Number of Patients With Abnormalities in Haematology: Haematocrit

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 32%.

Number of Patients With Abnormalities in Haematology: Red Blood Cell Count

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^12/L.

Number of Patients With Abnormalities in Haematology: White Blood Cell Count

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^9/L (decrease) or a value greater than 20.1 * 10^9/L (increase).

Number of Patients With Abnormalities in Haematology: Platelets

For this laboratory parameter, a possibly clinically significant abnormality is defined as value less than or equal to 75 * 10^9/L (decrease) or a value greater than or equal to 700 * 10^9/L (increase).

Number of Patients With Abnormalities in Clinical Chemistry: Potassium

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 mmol/L (decrease) or a value greater than 5.8 mmol/L (increase).

Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 11 mg/dL for male and as a value greater than 10 mg/dL for female patients.

Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.

Number of Patients With Abnormalities in Clinical Chemistry: Amylase

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 1.5 times the upper limit of normal (ULN).

Number of Patients With Abnormalities in Clinical Chemistry: γ-Glutamyl-transferase (GGT)

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.

Number of Patients With Abnormalities in Clinical Chemistry: Creatinine

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 1.5 mg/dL.

Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.

Number of Patients With Abnormalities in Clinical Chemistry: Phosphate

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 0.7 mmol/L (decrease) or a value greater than 1.7 mmol/L (increase).

Number of Patients With Abnormalities in Clinical Chemistry: Calcium

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 1.8 mmol/L (decrease) or a value greater than 3 mmol/L (increase).

Number of Patients With Abnormalities in Clinical Chemistry: Sodium

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 130 mmol/L (decrease) or a value greater than 160 mmol/L (increase).

Number of Patients With Abnormalities in Clinical Chemistry: Alanine Transaminase (ALT)

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.

Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST)

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.

Number of Patients With Abnormalities in Clinical Chemistry: Glucose

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 54 mg/dL.

Number of Patients With Abnormalities in Clinical Chemistry: Bilirubin

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 mg/dL.

Number of Patients With Abnormalities in Clinical Chemistry: Alkaline Phosphatase (AP)

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 times the ULN.

Number of Patients With Abnormalities in Clinical Chemistry: Albumin

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 2.5 g/dL.

Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH)

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.

Number of Patients With Abnormalities in Clinical Chemistry: Cholesterol

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.

Secondary Outcome Measures

Change in HbA1c From Baseline to Week 6

Change in HbA1c From Baseline to Week 18

Change in HbA1c From Baseline to Week 30

Change in HbA1c From Baseline to Week 42

Change in HbA1c From Baseline to Week 54

Change in HbA1c From Baseline to Week 66

Change in HbA1c From Baseline to Week 78

Number of Patients With HbA1c<7.0% Over Time

Number of Patients With HbA1c<6.5% Over Time

Number of Patients With Lowered HbA1c by at Least 0.5% Over Time

Change in FPG From Baseline to Week 6

Change in FPG From Baseline to Week 18

Change in FPG From Baseline to Week 30

Change in FPG From Baseline to Week 42

Change in FPG From Baseline to Week 54

Change in FPG From Baseline to Week 66

Change in FPG From Baseline to Week 78

Full Information

NCT ID

NCT00736099

First Posted

August 14, 2008

Last Updated

June 18, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00736099

Brief Title

Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM

Official Title

A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 1356 (5 mg) as Monotherapy or in Combination With Other Antidiabetic Medications in Type 2 Diabetic Patients.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

The objective of the current study is to investigate the safety and tolerability of BI 1356 (5 mg / once daily) given for 78 weeks in different modalities of treatment. The treatment modalities are determined by the treatment in the blinded trial in which every patient was included previously as BI 1356 in monotherapy (patients in 1218.16 trial), BI 1356 in combination with pioglitazone (patients in 1218.15 trial), BI 1356 added to metformin background (patients in 1218.17 trial) or BI 1356 added to a background therapy of metformin in combination with a sulphonylurea (patients in 1218.18 study)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

2122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

linagliptin 5 mg

Arm Type

Experimental

Arm Description

open label

Arm Title

linagliptin 5 mg and pioglitazone 30 mg

Arm Type

Experimental

Arm Description

open label

Intervention Type

Drug

Intervention Name(s)

linagliptine 5 mg

Intervention Description

safety and efficacy of linagliptine 5 mg open label

Intervention Type

Drug

Intervention Name(s)

linagliptine 5 mg and pioglitazone 30 mg

Intervention Description

efficacy and safety of the combination linagliptine and pioglitazone

Primary Outcome Measure Information:

Title

Frequency of Patients With Adverse Events (AEs)

Description

This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.

Time Frame

78 weeks

Title

Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events

Time Frame

78 weeks

Title

Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)

Description

Time Frame

78 weeks

Title

Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events

Description

Patients reported with cardiac and cerebrovascular events qualified for adjudication by the Clinical Event Committee (CEC)

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Vital Signs

Description

Vital sign abnormalities (any abnormalities found during PE or ECG are reported with adverse events)

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Haematology: Eosinophils

Description

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 10%.

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Haematology: Haemoglobin

Description

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Haematology: Haematocrit

Description

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 32%.

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Haematology: Red Blood Cell Count

Description

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^12/L.

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Haematology: White Blood Cell Count

Description

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^9/L (decrease) or a value greater than 20.1 * 10^9/L (increase).

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Haematology: Platelets

Description

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Clinical Chemistry: Potassium

Description

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 mmol/L (decrease) or a value greater than 5.8 mmol/L (increase).

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid

Description

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 11 mg/dL for male and as a value greater than 10 mg/dL for female patients.

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides

Description

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Clinical Chemistry: Amylase

Description

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 1.5 times the upper limit of normal (ULN).

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Clinical Chemistry: γ-Glutamyl-transferase (GGT)

Description

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Clinical Chemistry: Creatinine

Description

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 1.5 mg/dL.

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase

Description

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Clinical Chemistry: Phosphate

Description

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 0.7 mmol/L (decrease) or a value greater than 1.7 mmol/L (increase).

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Clinical Chemistry: Calcium

Description

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 1.8 mmol/L (decrease) or a value greater than 3 mmol/L (increase).

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Clinical Chemistry: Sodium

Description

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 130 mmol/L (decrease) or a value greater than 160 mmol/L (increase).

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Clinical Chemistry: Alanine Transaminase (ALT)

Description

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST)

Description

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Clinical Chemistry: Glucose

Description

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 54 mg/dL.

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Clinical Chemistry: Bilirubin

Description

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 mg/dL.

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Clinical Chemistry: Alkaline Phosphatase (AP)

Description

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 times the ULN.

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Clinical Chemistry: Albumin

Description

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 2.5 g/dL.

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH)

Description

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.

Time Frame

78 weeks

Title

Number of Patients With Abnormalities in Clinical Chemistry: Cholesterol

Description

For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.

Time Frame

78 weeks

Secondary Outcome Measure Information:

Title

Change in HbA1c From Baseline to Week 6

Time Frame

Baseline and week 6

Title

Change in HbA1c From Baseline to Week 18

Time Frame

Baseline and week 18

Title

Change in HbA1c From Baseline to Week 30

Time Frame

Baseline and week 30

Title

Change in HbA1c From Baseline to Week 42

Time Frame

Baseline and week 42

Title

Change in HbA1c From Baseline to Week 54

Time Frame

Baseline and week 54

Title

Change in HbA1c From Baseline to Week 66

Time Frame

Baseline and week 66

Title

Change in HbA1c From Baseline to Week 78

Time Frame

Baseline and week 78

Title

Number of Patients With HbA1c<7.0% Over Time

Time Frame

78 weeks

Title

Number of Patients With HbA1c<6.5% Over Time

Time Frame

78 weeks

Title

Number of Patients With Lowered HbA1c by at Least 0.5% Over Time

Time Frame

78 weeks

Title

Change in FPG From Baseline to Week 6

Time Frame

Baseline and week 6

Title

Change in FPG From Baseline to Week 18

Time Frame

Baseline and week 18

Title

Change in FPG From Baseline to Week 30

Time Frame

Baseline and week 30

Title

Change in FPG From Baseline to Week 42

Time Frame

Baseline and week 42

Title

Change in FPG From Baseline to Week 54

Time Frame

Baseline and week 54

Title

Change in FPG From Baseline to Week 66

Time Frame

Baseline and week 66

Title

Change in FPG From Baseline to Week 78

Time Frame

Baseline and week 78

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

82 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Signed and dated written informed consent in accordance with the GCP and local legislation. Patients completing the entire treatment period as a double blind trial whether or not they have been treated with rescue medication. Exclusion criteria: Patients who meet one or more of the withdrawal criteria of the treatment period of the previous trial. Pre-menopausal women (last menstruation =< 1 year prior to signing informed consent) who: are nursing or pregnant, or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, true sexual abstinence (when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of birth control) and vasectomised partners. No exception will be made. Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation. Drug abuse which, in the opinion of the investigator, would interfere with trial participation. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

1218.40.10003 Boehringer Ingelheim Investigational Site

City

Chula Vista

State/Province

California

Country

United States

Facility Name

1218.40.10014 Boehringer Ingelheim Investigational Site

City

Spring Valley

State/Province

California

Country

United States

Facility Name

1218.40.10001 Boehringer Ingelheim Investigational Site

City

Walnut Creek

State/Province

California

Country

United States

Facility Name

1218.40.10021 Boehringer Ingelheim Investigational Site

City

Northglenn

State/Province

Colorado

Country

United States

Facility Name

1218.40.10010 Boehringer Ingelheim Investigational Site

City

Hollywood

State/Province

Florida

Country

United States

Facility Name

1218.40.10011 Boehringer Ingelheim Investigational Site

City

Miami

State/Province

Florida

Country

United States

Facility Name

1218.40.10016 Boehringer Ingelheim Investigational Site

City

Eugene

State/Province

Oregon

Country

United States

Facility Name

1218.40.10002 Boehringer Ingelheim Investigational Site

City

Greer

State/Province

South Carolina

Country

United States

Facility Name

1218.40.10004 Boehringer Ingelheim Investigational Site

City

Simpsonville

State/Province

South Carolina

Country

United States

Facility Name

1218.40.10005 Boehringer Ingelheim Investigational Site

City

Dallas

State/Province

Texas

Country

United States

Facility Name

1218.40.10018 Boehringer Ingelheim Investigational Site

City

Houston

State/Province

Texas

Country

United States

Facility Name

1218.40.10007 Boehringer Ingelheim Investigational Site

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

1218.40.10009 Boehringer Ingelheim Investigational Site

City

Federal Way

State/Province

Washington

Country

United States

Facility Name

1218.40.54002 Boehringer Ingelheim Investigational Site

City

Capital Federal

Country

Argentina

Facility Name

1218.40.54010 Boehringer Ingelheim Investigational Site

City

Capital Federal

Country

Argentina

Facility Name

1218.40.54011 Boehringer Ingelheim Investigational Site

City

Mendoza

Country

Argentina

Facility Name

1218.40.54015 Boehringer Ingelheim Investigational Site

City

Parque Velez Sarfield

Country

Argentina

Facility Name

1218.40.43001 Boehringer Ingelheim Investigational Site

City

Graz

Country

Austria

Facility Name

1218.40.43005 Boehringer Ingelheim Investigational Site

City

Wien

Country

Austria

Facility Name

1218.40.32005 Boehringer Ingelheim Investigational Site

City

Brugge

Country

Belgium

Facility Name

1218.40.32007 Boehringer Ingelheim Investigational Site

City

Brussel

Country

Belgium

Facility Name

1218.40.32006 Boehringer Ingelheim Investigational Site

City

Edegem

Country

Belgium

Facility Name

1218.40.32004 Boehringer Ingelheim Investigational Site

City

Genk

Country

Belgium

Facility Name

1218.40.32003 Boehringer Ingelheim Investigational Site

City

Gent

Country

Belgium

Facility Name

1218.40.32002 Boehringer Ingelheim Investigational Site

City

Huy

Country

Belgium

Facility Name

1218.40.32001 Boehringer Ingelheim Investigational Site

City

Liège

Country

Belgium

Facility Name

1218.40.01005 Boehringer Ingelheim Investigational Site

City

Calgary

State/Province

Alberta

Country

Canada

Facility Name

1218.40.01010 Boehringer Ingelheim Investigational Site

City

Calgary

State/Province

Alberta

Country

Canada

Facility Name

1218.40.01003 Boehringer Ingelheim Investigational Site

City

Vancouver

State/Province

British Columbia

Country

Canada

Facility Name

1218.40.01011 Boehringer Ingelheim Investigational Site

City

Vancouver

State/Province

British Columbia

Country

Canada

Facility Name

1218.40.01006 Boehringer Ingelheim Investigational Site

City

Etobicoke

State/Province

Ontario

Country

Canada

Facility Name

1218.40.01009 Boehringer Ingelheim Investigational Site

City

Hamilton

State/Province

Ontario

Country

Canada

Facility Name

1218.40.01002 Boehringer Ingelheim Investigational Site

City

London

State/Province

Ontario

Country

Canada

Facility Name

1218.40.01012 Boehringer Ingelheim Investigational Site

City

Oakville

State/Province

Ontario

Country

Canada

Facility Name

1218.40.01008 Boehringer Ingelheim Investigational Site

City

Sarnia

State/Province

Ontario

Country

Canada

Facility Name

1218.40.20005 Boehringer Ingelheim Investigational Site

City

Strathroy

State/Province

Ontario

Country

Canada

Facility Name

1218.40.01001 Boehringer Ingelheim Investigational Site

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

1218.40.01004 Boehringer Ingelheim Investigational Site

City

Montague

State/Province

Prince Edward Island

Country

Canada

Facility Name

1218.40.01007 Boehringer Ingelheim Investigational Site

City

Saskatoon

State/Province

Saskatchewan

Country

Canada

Facility Name

1218.40.86001 Boehringer Ingelheim Investigational Site

City

Beijing

Country

China

Facility Name

1218.40.86002 Boehringer Ingelheim Investigational Site

City

Beijing

Country

China

Facility Name

1218.40.86004 Boehringer Ingelheim Investigational Site

City

Beijing

Country

China

Facility Name

1218.40.86013 Boehringer Ingelheim Investigational Site

City

Chengdu

Country

China

Facility Name

1218.40.86009 Boehringer Ingelheim Investigational Site

City

Dalian

Country

China

Facility Name

1218.40.86011 Boehringer Ingelheim Investigational Site

City

Guangzhou

Country

China

Facility Name

1218.40.86014 Boehringer Ingelheim Investigational Site

City

Haerbin

Country

China

Facility Name

1218.40.86008 Boehringer Ingelheim Investigational Site

City

Qingdao

Country

China

Facility Name

1218.40.86015 Boehringer Ingelheim Investigational Site

City

Shanghai

Country

China

Facility Name

1218.40.86010 Boehringer Ingelheim Investigational Site

City

Shenyang

Country

China

Facility Name

1218.40.86007 Boehringer Ingelheim Investigational Site

City

Wuhan

Country

China

Facility Name

1218.40.86012 Boehringer Ingelheim Investigational Site

City

Wuhan

Country

China

Facility Name

1218.40.86006 Boehringer Ingelheim Investigational Site

City

Xi'An

Country

China

Facility Name

1218.40.38605 Boehringer Ingelheim Investigational Site

City

Krapinske Toplice

Country

Croatia

Facility Name

1218.40.38604 Boehringer Ingelheim Investigational Site

City

Slavonski Brod

Country

Croatia

Facility Name

1218.40.42006 Boehringer Ingelheim Investigational Site

City

Breclav

Country

Czech Republic

Facility Name

1218.40.42004 Boehringer Ingelheim Investigational Site

City

Brno

Country

Czech Republic

Facility Name

1218.40.42007 Boehringer Ingelheim Investigational Site

City

Brno

Country

Czech Republic

Facility Name

1218.40.42009 Boehringer Ingelheim Investigational Site

City

Brno

Country

Czech Republic

Facility Name

1218.40.42008 Boehringer Ingelheim Investigational Site

City

Hodonin

Country

Czech Republic

Facility Name

1218.40.42003 Boehringer Ingelheim Investigational Site

City

Olomouc

Country

Czech Republic

Facility Name

1218.40.35806 Boehringer Ingelheim Investigational Site

City

Helsinki

Country

Finland

Facility Name

1218.40.35801 Boehringer Ingelheim Investigational Site

City

Kuopio

Country

Finland

Facility Name

1218.40.35803 Boehringer Ingelheim Investigational Site

City

Oulu

Country

Finland

Facility Name

1218.40.35805 Boehringer Ingelheim Investigational Site

City

Seinäjoki

Country

Finland

Facility Name

1218.40.35802 Boehringer Ingelheim Investigational Site

City

Turku

Country

Finland

Facility Name

1218.40.49028 Boehringer Ingelheim Investigational Site

City

Bad Mergentheim

Country

Germany

Facility Name

1218.40.49022 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1218.40.49024 Boehringer Ingelheim Investigational Site

City

Bosenheim

Country

Germany

Facility Name

1218.40.49020 Boehringer Ingelheim Investigational Site

City

Dresden

Country

Germany

Facility Name

1218.40.49101 Boehringer Ingelheim Investigational Site

City

Mainz

Country

Germany

Facility Name

1218.40.49003 Boehringer Ingelheim Investigational Site

City

Neuwied

Country

Germany

Facility Name

1218.40.49007 Boehringer Ingelheim Investigational Site

City

Nürnberg

Country

Germany

Facility Name

1218.40.49014 Boehringer Ingelheim Investigational Site

City

Saarbrücken

Country

Germany

Facility Name

1218.40.30004 Boehringer Ingelheim Investigational Site

City

Athens

Country

Greece

Facility Name

1218.40.30007 Boehringer Ingelheim Investigational Site

City

Athens

Country

Greece

Facility Name

1218.40.30013 Boehringer Ingelheim Investigational Site

City

Athens

Country

Greece

Facility Name

1218.40.30003 Boehringer Ingelheim Investigational Site

City

Nikaia

Country

Greece

Facility Name

1218.40.30011 Boehringer Ingelheim Investigational Site

City

Piraeus

Country

Greece

Facility Name

1218.40.30006 Boehringer Ingelheim Investigational Site

City

Thessaloniki

Country

Greece

Facility Name

1218.40.30016 Boehringer Ingelheim Investigational Site

City

Thessaloniki

Country

Greece

Facility Name

1218.40.36003 Boehringer Ingelheim Investigational Site

City

Budapest

Country

Hungary

Facility Name

1218.40.36004 Boehringer Ingelheim Investigational Site

City

Budapest

Country

Hungary

Facility Name

1218.40.36006 Boehringer Ingelheim Investigational Site

City

Budapest

Country

Hungary

Facility Name

1218.40.36008 Boehringer Ingelheim Investigational Site

City

Debrecen

Country

Hungary

Facility Name

1218.40.36005 Boehringer Ingelheim Investigational Site

City

Györ

Country

Hungary

Facility Name

1218.40.36002 Boehringer Ingelheim Investigational Site

City

Szombathely

Country

Hungary

Facility Name

1218.40.91010 Boehringer Ingelheim Investigational Site

City

Andhra Pradesh

Country

India

Facility Name

1218.40.91002 Boehringer Ingelheim Investigational Site

City

Bangalore

Country

India

Facility Name

1218.40.91005 Boehringer Ingelheim Investigational Site

City

Bangalore

Country

India

Facility Name

1218.40.91012 Boehringer Ingelheim Investigational Site

City

Chennai

Country

India

Facility Name

1218.40.91014 Boehringer Ingelheim Investigational Site

City

Chennai

Country

India

Facility Name

1218.40.91009 Boehringer Ingelheim Investigational Site

City

Hyderabad, Andra Pradesh

Country

India

Facility Name

1218.40.91006 Boehringer Ingelheim Investigational Site

City

Jaipur

Country

India

Facility Name

1218.40.91001 Boehringer Ingelheim Investigational Site

City

Kerala

Country

India

Facility Name

1218.40.91011 Boehringer Ingelheim Investigational Site

City

Maharashtra

Country

India

Facility Name

1218.40.91008 Boehringer Ingelheim Investigational Site

City

Mangalore

Country

India

Facility Name

1218.40.91007 Boehringer Ingelheim Investigational Site

City

Manipal

Country

India

Facility Name

1218.40.91004 Boehringer Ingelheim Investigational Site

City

Mumbai

Country

India

Facility Name

1218.40.91003 Boehringer Ingelheim Investigational Site

City

Nasik

Country

India

Facility Name

1218.40.91013 Boehringer Ingelheim Investigational Site

City

Uttar Pradesh

Country

India

Facility Name

1218.40.97274 Boehringer Ingelheim Investigational Site

City

Afula

Country

Israel

Facility Name

1218.40.97273 Boehringer Ingelheim Investigational Site

City

Haifa

Country

Israel

Facility Name

1218.40.97275 Boehringer Ingelheim Investigational Site

City

Holon

Country

Israel

Facility Name

1218.40.97271 Boehringer Ingelheim Investigational Site

City

Jerusalem

Country

Israel

Facility Name

1218.40.97272 Boehringer Ingelheim Investigational Site

City

Nahariya

Country

Israel

Facility Name

1218.40.97276 Boehringer Ingelheim Investigational Site

City

Safed

Country

Israel

Facility Name

1218.40.97278 Boehringer Ingelheim Investigational Site

City

Tel Aviv

Country

Israel

Facility Name

1218.40.39008 Boehringer Ingelheim Investigational Site

City

Genova

Country

Italy

Facility Name

1218.40.39002 Boehringer Ingelheim Investigational Site

City

Milano

Country

Italy

Facility Name

1218.40.39001 Boehringer Ingelheim Investigational Site

City

Pisa

Country

Italy

Facility Name

1218.40.39006 Boehringer Ingelheim Investigational Site

City

Roma

Country

Italy

Facility Name

1218.40.81001 Boehringer Ingelheim Investigational Site

City

Amagasaki, Hyogo

Country

Japan

Facility Name

1218.40.81005 Boehringer Ingelheim Investigational Site

City

Koganei, Tokyo

Country

Japan

Facility Name

1218.40.81002 Boehringer Ingelheim Investigational Site

City

Osaka, Osaka

Country

Japan

Facility Name

1218.40.81004 Boehringer Ingelheim Investigational Site

City

Shinjyuku-ku,Tokyo

Country

Japan

Facility Name

1218.40.81003 Boehringer Ingelheim Investigational Site

City

Suita, Osaka,

Country

Japan

Facility Name

1218.40.82002 Boehringer Ingelheim Investigational Site

City

Busan

Country

Korea, Republic of

Facility Name

1218.40.82011 Boehringer Ingelheim Investigational Site

City

Daegu

Country

Korea, Republic of

Facility Name

1218.40.82008 Boehringer Ingelheim Investigational Site

City

Incheon

Country

Korea, Republic of

Facility Name

1218.40.82010 Boehringer Ingelheim Investigational Site

City

Jeonju

Country

Korea, Republic of

Facility Name

1218.40.82004 Boehringer Ingelheim Investigational Site

City

Pusan

Country

Korea, Republic of

Facility Name

1218.40.82001 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1218.40.82005 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1218.40.82006 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1218.40.82007 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1218.40.82009 Boehringer Ingelheim Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

1218.40.82003 Boehringer Ingelheim Investigational Site

City

Suwon

Country

Korea, Republic of

Facility Name

1218.40.60003 Boehringer Ingelheim Investigational Site

City

Kelantan

Country

Malaysia

Facility Name

1218.40.60001 Boehringer Ingelheim Investigational Site

City

Kuala Lumpur

Country

Malaysia

Facility Name

1218.40.60002 Boehringer Ingelheim Investigational Site

City

Kuala Lumpur

Country

Malaysia

Facility Name

1218.40.60007 Boehringer Ingelheim Investigational Site

City

Penang

Country

Malaysia

Facility Name

1218.40.60004 Boehringer Ingelheim Investigational Site

City

Perak

Country

Malaysia

Facility Name

1218.40.60005 Boehringer Ingelheim Investigational Site

City

Perak

Country

Malaysia

Facility Name

1218.40.52007 Boehringer Ingelheim Investigational Site

City

Aguascalientes, Ags.

Country

Mexico

Facility Name

1218.40.52010 Boehringer Ingelheim Investigational Site

City

Col.Americana, Guadalajara, Jalisco

Country

Mexico

Facility Name

1218.40.52008 Boehringer Ingelheim Investigational Site

City

Colonia Tlalpan, mexico

Country

Mexico

Facility Name

1218.40.52006 Boehringer Ingelheim Investigational Site

City

Faccionamiento Lomas de Campestre,AGUASCAL

Country

Mexico

Facility Name

1218.40.52009 Boehringer Ingelheim Investigational Site

City

León

Country

Mexico

Facility Name

1218.40.52001 Boehringer Ingelheim Investigational Site

City

Monterrey N.L.

Country

Mexico

Facility Name

1218.40.52003 Boehringer Ingelheim Investigational Site

City

Monterrey

Country

Mexico

Facility Name

1218.40.52002 Boehringer Ingelheim Investigational Site

City

México

Country

Mexico

Facility Name

1218.40.52004 Boehringer Ingelheim Investigational Site

City

México

Country

Mexico

Facility Name

1218.40.52005 Boehringer Ingelheim Investigational Site

City

México

Country

Mexico

Facility Name

1218.40.31006 Boehringer Ingelheim Investigational Site

City

Deurne

Country

Netherlands

Facility Name

1218.40.31001 Boehringer Ingelheim Investigational Site

City

Ewijk

Country

Netherlands

Facility Name

1218.40.31010 Boehringer Ingelheim Investigational Site

City

Losser

Country

Netherlands

Facility Name

1218.40.31008 Boehringer Ingelheim Investigational Site

City

Roelofarendsveen

Country

Netherlands

Facility Name

1218.40.31002 Boehringer Ingelheim Investigational Site

City

Wildervank

Country

Netherlands

Facility Name

1218.40.64004 Boehringer Ingelheim Investigational Site

City

Christchurch

Country

New Zealand

Facility Name

1218.40.64003 Boehringer Ingelheim Investigational Site

City

Dunedin

Country

New Zealand

Facility Name

1218.40.64002 Boehringer Ingelheim Investigational Site

City

Otahuhu

Country

New Zealand

Facility Name

1218.40.64001 Boehringer Ingelheim Investigational Site

City

Tauranga

Country

New Zealand

Facility Name

1218.40.64005 Boehringer Ingelheim Investigational Site

City

Wellington

Country

New Zealand

Facility Name

1218.40.63003 Boehringer Ingelheim Investigational Site

City

Greenhills, San Juan

Country

Philippines

Facility Name

1218.40.63005 Boehringer Ingelheim Investigational Site

City

Manila

Country

Philippines

Facility Name

1218.40.63002 Boehringer Ingelheim Investigational Site

City

Marikina

Country

Philippines

Facility Name

1218.40.63001 Boehringer Ingelheim Investigational Site

City

Pasig

Country

Philippines

Facility Name

1218.40.63004 Boehringer Ingelheim Investigational Site

City

Quezon City

Country

Philippines

Facility Name

1218.40.48603 Boehringer Ingelheim Investigational Site

City

Lublin

Country

Poland

Facility Name

1218.40.48601 Boehringer Ingelheim Investigational Site

City

Warsaw

Country

Poland

Facility Name

1218.40.48604 Boehringer Ingelheim Investigational Site

City

Zabrze

Country

Poland

Facility Name

1218.40.40504 Boehringer Ingelheim Investigational Site

City

Alba Iulia

Country

Romania

Facility Name

1218.40.40604 Boehringer Ingelheim Investigational Site

City

Brasov

Country

Romania

Facility Name

1218.40.40501 Boehringer Ingelheim Investigational Site

City

Bucharest

Country

Romania

Facility Name

1218.40.40502 Boehringer Ingelheim Investigational Site

City

Bucharest

Country

Romania

Facility Name

1218.40.40603 Boehringer Ingelheim Investigational Site

City

Galati

Country

Romania

Facility Name

1218.40.40503 Boehringer Ingelheim Investigational Site

City

Sibiu

Country

Romania

Facility Name

1218.40.40505 Boehringer Ingelheim Investigational Site

City

Targu-Mures

Country

Romania

Facility Name

1218.40.70014 Boehringer Ingelheim Investigational Site

City

Arkhangelsk

Country

Russian Federation

Facility Name

1218.40.70001 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

1218.40.70002 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

1218.40.70003 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

1218.40.70012 Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

1218.40.70005 Boehringer Ingelheim Investigational Site

City

Novosibirsk

Country

Russian Federation

Facility Name

1218.40.70006 Boehringer Ingelheim Investigational Site

City

Perm

Country

Russian Federation

Facility Name

1218.40.70013 Boehringer Ingelheim Investigational Site

City

Rostov-on-Don

Country

Russian Federation

Facility Name

1218.40.70016 Boehringer Ingelheim Investigational Site

City

Samara

Country

Russian Federation

Facility Name

1218.40.70015 Boehringer Ingelheim Investigational Site

City

St. Petersburg

Country

Russian Federation

Facility Name

1218.40.70004 Boehringer Ingelheim Investigational Site

City

Tomsk

Country

Russian Federation

Facility Name

1218.40.42103 Boehringer Ingelheim Investigational Site

City

Banska Bystrica

Country

Slovakia

Facility Name

1218.40.42102 Boehringer Ingelheim Investigational Site

City

Bratislava

Country

Slovakia

Facility Name

1218.40.42104 Boehringer Ingelheim Investigational Site

City

Bratislava

Country

Slovakia

Facility Name

1218.40.42105 Boehringer Ingelheim Investigational Site

City

Bratislava

Country

Slovakia

Facility Name

1218.40.42101 Boehringer Ingelheim Investigational Site

City

Nove Mesto

Country

Slovakia

Facility Name

1218.40.42106 Boehringer Ingelheim Investigational Site

City

Samorin

Country

Slovakia

Facility Name

1218.40.34002 Boehringer Ingelheim Investigational Site

City

Badalona

Country

Spain

Facility Name

1218.40.34011 Boehringer Ingelheim Investigational Site

City

Badia del Vallés

Country

Spain

Facility Name

1218.40.34012 Boehringer Ingelheim Investigational Site

City

Borges del Camp

Country

Spain

Facility Name

1218.40.34013 Boehringer Ingelheim Investigational Site

City

Centelles

Country

Spain

Facility Name

1218.40.34007 Boehringer Ingelheim Investigational Site

City

Granada

Country

Spain

Facility Name

1218.40.34008 Boehringer Ingelheim Investigational Site

City

L'Hospitalet de Llobregat (Barcelona)

Country

Spain

Facility Name

1218.40.34009 Boehringer Ingelheim Investigational Site

City

L'Hospitalet de Llobregat (Barcelona)

Country

Spain

Facility Name

1218.40.34004 Boehringer Ingelheim Investigational Site

City

Madrid

Country

Spain

Facility Name

1218.40.34006 Boehringer Ingelheim Investigational Site

City

Madrid

Country

Spain

Facility Name

1218.40.34010 Boehringer Ingelheim Investigational Site

City

Sant Adrià del Besós (Barcelona)

Country

Spain

Facility Name

1218.40.34005 Boehringer Ingelheim Investigational Site

City

Sevilla

Country

Spain

Facility Name

1218.40.34014 Boehringer Ingelheim Investigational Site

City

Vic (Barcelona)

Country

Spain

Facility Name

1218.40.46013 Boehringer Ingelheim Investigational Site

City

Härnösand

Country

Sweden

Facility Name

1218.40.46001 Boehringer Ingelheim Investigational Site

City

Malmö

Country

Sweden

Facility Name

1218.40.46012 Boehringer Ingelheim Investigational Site

City

Uddevalla

Country

Sweden

Facility Name

1218.40.46004 Boehringer Ingelheim Investigational Site

City

Uppsala

Country

Sweden

Facility Name

1218.40.88605 Boehringer Ingelheim Investigational Site

City

ChangHua

Country

Taiwan

Facility Name

1218.40.88604 Boehringer Ingelheim Investigational Site

City

Taichung

Country

Taiwan

Facility Name

1218.40.88606 Boehringer Ingelheim Investigational Site

City

Tainan

Country

Taiwan

Facility Name

1218.40.88601 Boehringer Ingelheim Investigational Site

City

Taipei

Country

Taiwan

Facility Name

1218.40.88602 Boehringer Ingelheim Investigational Site

City

Taipei

Country

Taiwan

Facility Name

1218.40.88603 Boehringer Ingelheim Investigational Site

City

Taipei

Country

Taiwan

Facility Name

1218.40.88607 Boehringer Ingelheim Investigational Site

City

Taipei

Country

Taiwan

Facility Name

1218.40.88608 Boehringer Ingelheim Investigational Site

City

Taoyuan

Country

Taiwan

Facility Name

1218.40.66001 Boehringer Ingelheim Investigational Site

City

Bangkok

Country

Thailand

Facility Name

1218.40.66002 Boehringer Ingelheim Investigational Site

City

Khon Kaen

Country

Thailand

Facility Name

1218.40.38011 Boehringer Ingelheim Investigational Site

City

Dnepropetrovsk

Country

Ukraine

Facility Name

1218.40.38002 Boehringer Ingelheim Investigational Site

City

Kharkov

Country

Ukraine

Facility Name

1218.40.38004 Boehringer Ingelheim Investigational Site

City

Kharkov

Country

Ukraine

Facility Name

1218.40.38010 Boehringer Ingelheim Investigational Site

City

Kharkov

Country

Ukraine

Facility Name

1218.40.38001 Boehringer Ingelheim Investigational Site

City

Kiev

Country

Ukraine

Facility Name

1218.40.38005 Boehringer Ingelheim Investigational Site

City

Kiev

Country

Ukraine

Facility Name

1218.40.38008 Boehringer Ingelheim Investigational Site

City

Kiev

Country

Ukraine

Facility Name

1218.40.38009 Boehringer Ingelheim Investigational Site

City

Kiev

Country

Ukraine

Facility Name

1218.40.38012 Boehringer Ingelheim Investigational Site

City

Kiev

Country

Ukraine

Facility Name

1218.40.38003 Boehringer Ingelheim Investigational Site

City

Lvov

Country

Ukraine

Facility Name

1218.40.38006 Boehringer Ingelheim Investigational Site

City

Vinnitsa

Country

Ukraine

Facility Name

1218.40.38007 Boehringer Ingelheim Investigational Site

City

Zaporizhzhya

Country

Ukraine

Facility Name

1218.40.44005 Boehringer Ingelheim Investigational Site

City

Ashford

Country

United Kingdom

Facility Name

1218.40.44004 Boehringer Ingelheim Investigational Site

City

Baillieston, Glasgow

Country

United Kingdom

Facility Name

1218.40.44001 Boehringer Ingelheim Investigational Site

City

Bath

Country

United Kingdom

Facility Name

1218.40.44003 Boehringer Ingelheim Investigational Site

City

Burbage

Country

United Kingdom

Facility Name

1218.40.44010 Boehringer Ingelheim Investigational Site

City

Bury St Edmonds

Country

United Kingdom

Facility Name

1218.40.44009 Boehringer Ingelheim Investigational Site

City

Cardiff

Country

United Kingdom

Facility Name

1218.40.44002 Boehringer Ingelheim Investigational Site

City

Penarth

Country

United Kingdom

Facility Name

1218.40.44006 Boehringer Ingelheim Investigational Site

City

Reading

Country

United Kingdom

Facility Name

1218.40.44007 Boehringer Ingelheim Investigational Site

City

Waterloo, Liverpool

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.40_U11-1708-02.pdf

Description

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Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM

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Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM

Diabetes Mellitus, Type 2

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial