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

NCT00736099 | Completed Phase 3 Results

• 2 other identifiers: 1218.402008-000750-13
• Study Type: interventional
• Target: 2,122
• Locations: 32 countries
• Sites: 232

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)

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (29)

• Frequency of Patients With Adverse Events (AEs)

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

  78 weeks

• Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events

  78 weeks

• 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'').

  78 weeks

• 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)

  78 weeks

• Number of Patients With Abnormalities in Vital Signs

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

  78 weeks

• 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%.

  78 weeks

• 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.

  78 weeks

• 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%.

  78 weeks

• 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.

  78 weeks

• 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).

  78 weeks

• 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).

  78 weeks

• 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).

  78 weeks

• 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.

  78 weeks

• 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.

  78 weeks

• 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).

  78 weeks

• 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.

  78 weeks

• 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.

  78 weeks

• 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.

  78 weeks

• 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).

  78 weeks

• 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).

  78 weeks

• 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).

  78 weeks

• 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.

  78 weeks

• 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.

  78 weeks

• 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.

  78 weeks

• 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.

  78 weeks

• 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.

  78 weeks

• 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.

  78 weeks

• 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.

  78 weeks

• 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.

  78 weeks

Secondary Outcomes (17)

• Change in HbA1c From Baseline to Week 6

  Baseline and week 6

• Change in HbA1c From Baseline to Week 18

  Baseline and week 18

• Change in HbA1c From Baseline to Week 30

  Baseline and week 30

• Change in HbA1c From Baseline to Week 42

  Baseline and week 42

• Change in HbA1c From Baseline to Week 54

  Baseline and week 54

Study Arms (2)

linagliptin 5 mg

EXPERIMENTAL

open label

Drug: linagliptine 5 mg

linagliptin 5 mg and pioglitazone 30 mg

EXPERIMENTAL

open label

Drug: linagliptine 5 mg and pioglitazone 30 mg

Interventions

linagliptine 5 mg DRUG

safety and efficacy of linagliptine 5 mg open label

linagliptin 5 mg

linagliptine 5 mg and pioglitazone 30 mg DRUG

efficacy and safety of the combination linagliptine and pioglitazone

linagliptin 5 mg and pioglitazone 30 mg

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (232)

1218.40.10003 Boehringer Ingelheim Investigational Site

Chula Vista, California, United States

Location

1218.40.10014 Boehringer Ingelheim Investigational Site

Spring Valley, California, United States

Location

1218.40.10001 Boehringer Ingelheim Investigational Site

Walnut Creek, California, United States

Location

1218.40.10021 Boehringer Ingelheim Investigational Site

Northglenn, Colorado, United States

Location

1218.40.10010 Boehringer Ingelheim Investigational Site

Hollywood, Florida, United States

Location

1218.40.10011 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1218.40.10016 Boehringer Ingelheim Investigational Site

Eugene, Oregon, United States

Location

1218.40.10002 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

Location

1218.40.10004 Boehringer Ingelheim Investigational Site

Simpsonville, South Carolina, United States

Location

1218.40.10005 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1218.40.10018 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1218.40.10007 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1218.40.10009 Boehringer Ingelheim Investigational Site

Federal Way, Washington, United States

Location

1218.40.54002 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1218.40.54010 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1218.40.54011 Boehringer Ingelheim Investigational Site

Mendoza, Argentina

Location

1218.40.54015 Boehringer Ingelheim Investigational Site

Parque Velez Sarfield, Argentina

Location

1218.40.43001 Boehringer Ingelheim Investigational Site

Graz, Austria

Location

1218.40.43005 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1218.40.32005 Boehringer Ingelheim Investigational Site

Bruges, Belgium

Location

1218.40.32007 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1218.40.32006 Boehringer Ingelheim Investigational Site

Edegem, Belgium

Location

1218.40.32004 Boehringer Ingelheim Investigational Site

Genk, Belgium

Location

1218.40.32003 Boehringer Ingelheim Investigational Site

Ghent, Belgium

Location

1218.40.32002 Boehringer Ingelheim Investigational Site

Huy, Belgium

Location

1218.40.32001 Boehringer Ingelheim Investigational Site

Liège, Belgium

Location

1218.40.01005 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Location

1218.40.01010 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Location

1218.40.01003 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1218.40.01011 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1218.40.01006 Boehringer Ingelheim Investigational Site

Etobicoke, Ontario, Canada

Location

1218.40.01009 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1218.40.01002 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Location

1218.40.01012 Boehringer Ingelheim Investigational Site

Oakville, Ontario, Canada

Location

1218.40.01008 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Location

1218.40.20005 Boehringer Ingelheim Investigational Site

Strathroy, Ontario, Canada

Location

1218.40.01001 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1218.40.01004 Boehringer Ingelheim Investigational Site

Montague, Prince Edward Island, Canada

Location

1218.40.01007 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Location

1218.40.86001 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1218.40.86002 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1218.40.86004 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1218.40.86013 Boehringer Ingelheim Investigational Site

Chengdu, China

Location

1218.40.86009 Boehringer Ingelheim Investigational Site

Dalian, China

Location

1218.40.86011 Boehringer Ingelheim Investigational Site

Guangzhou, China

Location

1218.40.86014 Boehringer Ingelheim Investigational Site

Haerbin, China

Location

1218.40.86008 Boehringer Ingelheim Investigational Site

Qingdao, China

Location

1218.40.86015 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1218.40.86010 Boehringer Ingelheim Investigational Site

Shenyang, China

Location

1218.40.86007 Boehringer Ingelheim Investigational Site

Wuhan, China

Location

1218.40.86012 Boehringer Ingelheim Investigational Site

Wuhan, China

Location

1218.40.86006 Boehringer Ingelheim Investigational Site

Xi'an, China

Location

1218.40.38605 Boehringer Ingelheim Investigational Site

Krapinske Toplice, Croatia

Location

1218.40.38604 Boehringer Ingelheim Investigational Site

Slavonski Brod, Croatia

Location

1218.40.42004 Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

1218.40.42007 Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

1218.40.42009 Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

1218.40.42006 Boehringer Ingelheim Investigational Site

Břeclav, Czechia

Location

1218.40.42008 Boehringer Ingelheim Investigational Site

Hodonín, Czechia

Location

1218.40.42003 Boehringer Ingelheim Investigational Site

Olomouc, Czechia

Location

1218.40.35806 Boehringer Ingelheim Investigational Site

Helsinki, Finland

Location

1218.40.35801 Boehringer Ingelheim Investigational Site

Kuopio, Finland

Location

1218.40.35803 Boehringer Ingelheim Investigational Site

Oulu, Finland

Location

1218.40.35805 Boehringer Ingelheim Investigational Site

Seinäjoki, Finland

Location

1218.40.35802 Boehringer Ingelheim Investigational Site

Turku, Finland

Location

1218.40.49028 Boehringer Ingelheim Investigational Site

Bad Mergentheim, Germany

Location

1218.40.49022 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1218.40.49024 Boehringer Ingelheim Investigational Site

Bosenheim, Germany

Location

1218.40.49020 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

1218.40.49101 Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

1218.40.49003 Boehringer Ingelheim Investigational Site

Neuwied, Germany

Location

1218.40.49007 Boehringer Ingelheim Investigational Site

Nuremberg, Germany

Location

1218.40.49014 Boehringer Ingelheim Investigational Site

Saarbrücken, Germany

Location

1218.40.30004 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1218.40.30007 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1218.40.30013 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1218.40.30003 Boehringer Ingelheim Investigational Site

Nikaia, Greece

Location

1218.40.30011 Boehringer Ingelheim Investigational Site

Piraeus, Greece

Location

1218.40.30006 Boehringer Ingelheim Investigational Site

Thessaloniki, Greece

Location

1218.40.30016 Boehringer Ingelheim Investigational Site

Thessaloniki, Greece

Location

1218.40.36003 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1218.40.36004 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1218.40.36006 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1218.40.36008 Boehringer Ingelheim Investigational Site

Debrecen, Hungary

Location

1218.40.36005 Boehringer Ingelheim Investigational Site

Győr, Hungary

Location

1218.40.36002 Boehringer Ingelheim Investigational Site

Szombathely, Hungary

Location

1218.40.91010 Boehringer Ingelheim Investigational Site

Andhra Pradesh, India

Location

1218.40.91002 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1218.40.91005 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1218.40.91012 Boehringer Ingelheim Investigational Site

Chennai, India

Location

1218.40.91014 Boehringer Ingelheim Investigational Site

Chennai, India

Location

1218.40.91009 Boehringer Ingelheim Investigational Site

Hyderabad, Andra Pradesh, India

Location

1218.40.91006 Boehringer Ingelheim Investigational Site

Jaipur, India

Location

1218.40.91001 Boehringer Ingelheim Investigational Site

Kerala, India

Location

1218.40.91011 Boehringer Ingelheim Investigational Site

Maharashtra, India

Location

1218.40.91008 Boehringer Ingelheim Investigational Site

Mangalore, India

Location

1218.40.91007 Boehringer Ingelheim Investigational Site

Manipal, India

Location

1218.40.91004 Boehringer Ingelheim Investigational Site

Mumbai, India

Location

1218.40.91003 Boehringer Ingelheim Investigational Site

Nashik, India

Location

1218.40.91013 Boehringer Ingelheim Investigational Site

Uttar Pradesh, India

Location

1218.40.97274 Boehringer Ingelheim Investigational Site

Afula, Israel

Location

1218.40.97273 Boehringer Ingelheim Investigational Site

Haifa, Israel

Location

1218.40.97275 Boehringer Ingelheim Investigational Site

Holon, Israel

Location

1218.40.97271 Boehringer Ingelheim Investigational Site

Jerusalem, Israel

Location

1218.40.97272 Boehringer Ingelheim Investigational Site

Nahariya, Israel

Location

1218.40.97276 Boehringer Ingelheim Investigational Site

Safed, Israel

Location

1218.40.97278 Boehringer Ingelheim Investigational Site

Tel Aviv, Israel

Location

1218.40.39008 Boehringer Ingelheim Investigational Site

Genova, Italy

Location

1218.40.39002 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

1218.40.39001 Boehringer Ingelheim Investigational Site

Pisa, Italy

Location

1218.40.39006 Boehringer Ingelheim Investigational Site

Roma, Italy

Location

1218.40.81001 Boehringer Ingelheim Investigational Site

Amagasaki, Hyogo, Japan

Location

1218.40.81005 Boehringer Ingelheim Investigational Site

Koganei, Tokyo, Japan

Location

1218.40.81002 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

1218.40.81004 Boehringer Ingelheim Investigational Site

Shinjyuku-ku,Tokyo, Japan

Location

1218.40.81003 Boehringer Ingelheim Investigational Site

Suita, Osaka,, Japan

Location

1218.40.60007 Boehringer Ingelheim Investigational Site

George Town, Malaysia

Location

1218.40.60003 Boehringer Ingelheim Investigational Site

Kelantan, Malaysia

Location

1218.40.60001 Boehringer Ingelheim Investigational Site

Kuala Lumpur, Malaysia

Location

1218.40.60002 Boehringer Ingelheim Investigational Site

Kuala Lumpur, Malaysia

Location

1218.40.60004 Boehringer Ingelheim Investigational Site

Perak, Malaysia

Location

1218.40.60005 Boehringer Ingelheim Investigational Site

Perak, Malaysia

Location

1218.40.52007 Boehringer Ingelheim Investigational Site

Aguascalientes, Ags., Mexico

Location

1218.40.52010 Boehringer Ingelheim Investigational Site

Col.Americana, Guadalajara, Jalisco, Mexico

Location

1218.40.52008 Boehringer Ingelheim Investigational Site

Colonia Tlalpan, Mexico, Mexico

Location

1218.40.52006 Boehringer Ingelheim Investigational Site

Faccionamiento Lomas de Campestre,AGUASCAL, Mexico

Location

1218.40.52009 Boehringer Ingelheim Investigational Site

León, Mexico

Location

1218.40.52002 Boehringer Ingelheim Investigational Site

México, Mexico

Location

1218.40.52004 Boehringer Ingelheim Investigational Site

México, Mexico

Location

1218.40.52005 Boehringer Ingelheim Investigational Site

México, Mexico

Location

1218.40.52003 Boehringer Ingelheim Investigational Site

Monterrey, Mexico

Location

1218.40.52001 Boehringer Ingelheim Investigational Site

Monterrey N.L., Mexico

Location

1218.40.31006 Boehringer Ingelheim Investigational Site

Deurne, Netherlands

Location

1218.40.31001 Boehringer Ingelheim Investigational Site

Ewijk, Netherlands

Location

1218.40.31010 Boehringer Ingelheim Investigational Site

Losser, Netherlands

Location

1218.40.31008 Boehringer Ingelheim Investigational Site

Roelofarendsveen, Netherlands

Location

1218.40.31002 Boehringer Ingelheim Investigational Site

Wildervank, Netherlands

Location

1218.40.64004 Boehringer Ingelheim Investigational Site

Christchurch, New Zealand

Location

1218.40.64003 Boehringer Ingelheim Investigational Site

Dunedin, New Zealand

Location

1218.40.64002 Boehringer Ingelheim Investigational Site

Otahuhu, New Zealand

Location

1218.40.64001 Boehringer Ingelheim Investigational Site

Tauranga, New Zealand

Location

1218.40.64005 Boehringer Ingelheim Investigational Site

Wellington, New Zealand

Location

1218.40.63003 Boehringer Ingelheim Investigational Site

Greenhills, San Juan, Philippines

Location

1218.40.63005 Boehringer Ingelheim Investigational Site

Manila, Philippines

Location

1218.40.63002 Boehringer Ingelheim Investigational Site

Marikina City, Philippines

Location

1218.40.63001 Boehringer Ingelheim Investigational Site

Pasig, Philippines

Location

1218.40.63004 Boehringer Ingelheim Investigational Site

Quezon City, Philippines

Location

1218.40.48603 Boehringer Ingelheim Investigational Site

Lublin, Poland

Location

1218.40.48601 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1218.40.48604 Boehringer Ingelheim Investigational Site

Zabrze, Poland

Location

1218.40.40504 Boehringer Ingelheim Investigational Site

Alba Iulia, Romania

Location

1218.40.40604 Boehringer Ingelheim Investigational Site

Brasov, Romania

Location

1218.40.40501 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1218.40.40502 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1218.40.40603 Boehringer Ingelheim Investigational Site

Galati, Romania

Location

1218.40.40503 Boehringer Ingelheim Investigational Site

Sibiu, Romania

Location

1218.40.40505 Boehringer Ingelheim Investigational Site

Târgu Mureş, Romania

Location

1218.40.70014 Boehringer Ingelheim Investigational Site

Arkhangelsk, Russia

Location

1218.40.70001 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.40.70002 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.40.70003 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.40.70012 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.40.70005 Boehringer Ingelheim Investigational Site

Novosibirsk, Russia

Location

1218.40.70006 Boehringer Ingelheim Investigational Site

Perm, Russia

Location

1218.40.70013 Boehringer Ingelheim Investigational Site

Rostov-on-Don, Russia

Location

1218.40.70015 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1218.40.70016 Boehringer Ingelheim Investigational Site

Samara, Russia

Location

1218.40.70004 Boehringer Ingelheim Investigational Site

Tomsk, Russia

Location

1218.40.42103 Boehringer Ingelheim Investigational Site

Banská Bystrica, Slovakia

Location

1218.40.42102 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

1218.40.42104 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

1218.40.42105 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

1218.40.42101 Boehringer Ingelheim Investigational Site

Nové Mesto, Slovakia

Location

1218.40.42106 Boehringer Ingelheim Investigational Site

Šamorín, Slovakia

Location

1218.40.82002 Boehringer Ingelheim Investigational Site

Busan, South Korea

Location

1218.40.82011 Boehringer Ingelheim Investigational Site

Daegu, South Korea

Location

1218.40.82008 Boehringer Ingelheim Investigational Site

Incheon, South Korea

Location

1218.40.82010 Boehringer Ingelheim Investigational Site

Jeonju, South Korea

Location

1218.40.82004 Boehringer Ingelheim Investigational Site

Pusan, South Korea

Location

1218.40.82001 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1218.40.82005 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1218.40.82006 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1218.40.82007 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1218.40.82009 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1218.40.82003 Boehringer Ingelheim Investigational Site

Suwon, South Korea

Location

1218.40.34002 Boehringer Ingelheim Investigational Site

Badalona, Spain

Location

1218.40.34011 Boehringer Ingelheim Investigational Site

Badia Del Vallés, Spain

Location

1218.40.34012 Boehringer Ingelheim Investigational Site

Borges Del Camp, Spain

Location

1218.40.34013 Boehringer Ingelheim Investigational Site

Centelles, Spain

Location

1218.40.34007 Boehringer Ingelheim Investigational Site

Granada, Spain

Location

1218.40.34008 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat (Barcelona), Spain

Location

1218.40.34009 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat (Barcelona), Spain

Location

1218.40.34004 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1218.40.34006 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1218.40.34010 Boehringer Ingelheim Investigational Site

Sant Adrià Del Besós (Barcelona), Spain

Location

1218.40.34005 Boehringer Ingelheim Investigational Site

Seville, Spain

Location

1218.40.34014 Boehringer Ingelheim Investigational Site

Vic (Barcelona), Spain

Location

1218.40.46013 Boehringer Ingelheim Investigational Site

Härnösand, Sweden

Location

1218.40.46001 Boehringer Ingelheim Investigational Site

Malmo, Sweden

Location

1218.40.46012 Boehringer Ingelheim Investigational Site

Uddevalla, Sweden

Location

1218.40.46004 Boehringer Ingelheim Investigational Site

Uppsala, Sweden

Location

1218.40.88605 Boehringer Ingelheim Investigational Site

Changhua, Taiwan

Location

1218.40.88604 Boehringer Ingelheim Investigational Site

Taichung, Taiwan

Location

1218.40.88606 Boehringer Ingelheim Investigational Site

Tainan, Taiwan

Location

1218.40.88601 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1218.40.88602 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1218.40.88603 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1218.40.88607 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1218.40.88608 Boehringer Ingelheim Investigational Site

Taoyuan District, Taiwan

Location

1218.40.66001 Boehringer Ingelheim Investigational Site

Bangkok, Thailand

Location

1218.40.66002 Boehringer Ingelheim Investigational Site

Khon Kaen, Thailand

Location

1218.40.38011 Boehringer Ingelheim Investigational Site

Dnipro, Ukraine

Location

1218.40.38002 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1218.40.38004 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1218.40.38010 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1218.40.38001 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1218.40.38005 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1218.40.38008 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1218.40.38009 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1218.40.38012 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1218.40.38003 Boehringer Ingelheim Investigational Site

Lviv, Ukraine

Location

1218.40.38006 Boehringer Ingelheim Investigational Site

Vinnitsa, Ukraine

Location

1218.40.38007 Boehringer Ingelheim Investigational Site

Zaporizhzhya, Ukraine

Location

1218.40.44005 Boehringer Ingelheim Investigational Site

Ashford, United Kingdom

Location

1218.40.44004 Boehringer Ingelheim Investigational Site

Baillieston, Glasgow, United Kingdom

Location

1218.40.44001 Boehringer Ingelheim Investigational Site

Bath, United Kingdom

Location

1218.40.44003 Boehringer Ingelheim Investigational Site

Burbage, United Kingdom

Location

1218.40.44010 Boehringer Ingelheim Investigational Site

Bury Saint Edmonds, United Kingdom

Location

1218.40.44009 Boehringer Ingelheim Investigational Site

Cardiff, United Kingdom

Location

1218.40.44002 Boehringer Ingelheim Investigational Site

Penarth, United Kingdom

Location

1218.40.44006 Boehringer Ingelheim Investigational Site

Reading, United Kingdom

Location

1218.40.44007 Boehringer Ingelheim Investigational Site

Waterloo, Liverpool, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 15, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2010
• Last Updated: June 27, 2014
• Results First Posted: March 8, 2012

Record last verified: 2013-12

Locations

US (13); ME (10); DE (8); CZ (6); GR (7); IT (4); NZ (5); BE (7); CR (2); SL (6); KR (11); TH (2); HU (6); UA (12); NL (5); TW (8); GB (9); AU (2); CA (13); FI (5); JP (5); IN (14); RO (7); SE (4); CN (13); PH (5); ES (12); IL (7); AR (4); MY (6); PL (3); RU (11)