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Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design

NCT ID: NCT00798161

Last Updated: 2014-01-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

857 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Brief Summary

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The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic patients with very poor glycaemic control for 24 weeks

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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BI 1356 + metformin

BI 1356 low dose + metformin 500 mg, twice daily

Group Type EXPERIMENTAL

BI 1356 + metformin

Intervention Type DRUG

BI 1356 low dose tablet + Metformin 500 mg tablet, twice daily

matching placebo

matching placebo

Group Type PLACEBO_COMPARATOR

matching placebo

Intervention Type DRUG

matching placebo

BI 1356+ Metformin

BI 1356 low dose + metformin 1000 mg, twice daily

Group Type EXPERIMENTAL

Bi 1356 + metformin

Intervention Type DRUG

BI 1356 low dose tablet + Metformin 1000 mg tablet, twice daily

Metformin

Metformin 500 mg, twice daily

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Metformin 500 mg tablet, twice daily

metformin

Metformin 1000 mg, twice daily

Group Type ACTIVE_COMPARATOR

metformin

Intervention Type DRUG

metformin 1000 mg tablet, twice daily

BI 1356

BI 1356 high dose, once daily

Group Type EXPERIMENTAL

BI 1356

Intervention Type DRUG

BI 1356 high dose tablet, once daily

Interventions

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BI 1356

BI 1356 high dose tablet, once daily

Intervention Type DRUG

BI 1356 + metformin

BI 1356 low dose tablet + Metformin 500 mg tablet, twice daily

Intervention Type DRUG

Bi 1356 + metformin

BI 1356 low dose tablet + Metformin 1000 mg tablet, twice daily

Intervention Type DRUG

Metformin

Metformin 500 mg tablet, twice daily

Intervention Type DRUG

metformin

metformin 1000 mg tablet, twice daily

Intervention Type DRUG

matching placebo

matching placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients with type 2 diabetes (drug naive or pre-treated) with insufficient glycaemic control (HbA1c higher or equal than 7.5 to less than 11.0 %), with very poor glycaemic control (HbA1c higher or equal than 11.0 %) who are not eligible for randomisation to be included in the open-label arm

Exclusion Criteria

Myocardial infarction, stroke or transient ischemic attack (TIA), unstable or acute congestive heart failure, impaired hepatic function, treatment with rosiglitazone or pioglitazone, with a GLP1 analogue, with insulin, with anti-obesity drugs, with systemic steroids, renal failure or impairment, gastric bypass
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1218.46.11005 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Site Status

1218.46.11003 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Site Status

1218.46.11002 Boehringer Ingelheim Investigational Site

Red Deer, Alberta, Canada

Site Status

1218.46.11006 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1218.46.11008 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Site Status

1218.46.11004 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

1218.46.11007 Boehringer Ingelheim Investigational Site

Oakville, Ontario, Canada

Site Status

1218.46.11009 Boehringer Ingelheim Investigational Site

Oshawa, Ontario, Canada

Site Status

1218.46.11010 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1218.46.38502 Boehringer Ingelheim Investigational Site

Karlovac, , Croatia

Site Status

1218.46.38503 Boehringer Ingelheim Investigational Site

Krapinske Toplice, , Croatia

Site Status

1218.46.38504 Boehringer Ingelheim Investigational Site

Osijek, , Croatia

Site Status

1218.46.38505 Boehringer Ingelheim Investigational Site

Rijeka, , Croatia

Site Status

1218.46.38501 Boehringer Ingelheim Investigational Site

Sisak, , Croatia

Site Status

1218.46.38506 Boehringer Ingelheim Investigational Site

Zagreb, , Croatia

Site Status

1218.46.37202 Boehringer Ingelheim Investigational Site

Pärnu, , Estonia

Site Status

1218.46.37201 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

Site Status

1218.46.37203 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

Site Status

1218.46.3303D Boehringer Ingelheim Investigational Site

Aire Sur l'Aadour, , France

Site Status

1218.46.3308B Boehringer Ingelheim Investigational Site

Bischheim, , France

Site Status

1218.46.3305A Boehringer Ingelheim Investigational Site

Bourges, , France

Site Status

1218.46.3304F Boehringer Ingelheim Investigational Site

Bousse, , France

Site Status

1218.46.3306D Boehringer Ingelheim Investigational Site

Carresse-Cassaber, , France

Site Status

1218.46.3308C Boehringer Ingelheim Investigational Site

Gambsheim, , France

Site Status

1218.46.3305D Boehringer Ingelheim Investigational Site

Garchizy, , France

Site Status

1218.46.3301A Boehringer Ingelheim Investigational Site

Grenoble Cédex, , France

Site Status

1218.46.3305B Boehringer Ingelheim Investigational Site

Guérigny, , France

Site Status

1218.46.3304A Boehringer Ingelheim Investigational Site

Jarny, , France

Site Status

1218.46.3302D Boehringer Ingelheim Investigational Site

La Riche, , France

Site Status

1218.46.3307A Boehringer Ingelheim Investigational Site

La Seyne-sur-Mer, , France

Site Status

1218.46.3307E Boehringer Ingelheim Investigational Site

La Seyne-sur-Mer, , France

Site Status

1218.46.3305G Boehringer Ingelheim Investigational Site

Lury-sur-Arnon, , France

Site Status

1218.46.3304D Boehringer Ingelheim Investigational Site

Mars-la-Tour, , France

Site Status

1218.46.3304B Boehringer Ingelheim Investigational Site

Mondelange, , France

Site Status

1218.46.3303A Boehringer Ingelheim Investigational Site

Mont-de-Marsan, , France

Site Status

1218.46.3303C Boehringer Ingelheim Investigational Site

Mont-de-Marsan, , France

Site Status

1218.46.3303E Boehringer Ingelheim Investigational Site

Mont-de-Marsan, , France

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1218.46.3304C Boehringer Ingelheim Investigational Site

Moûtiers, , France

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1218.46.3308F Boehringer Ingelheim Investigational Site

Mundolsheim, , France

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1218.46.3305C Boehringer Ingelheim Investigational Site

Nevers, , France

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1218.46.3305E Boehringer Ingelheim Investigational Site

Nevers, , France

Site Status

1218.46.3306A Boehringer Ingelheim Investigational Site

Orthez, , France

Site Status

1218.46.3306C Boehringer Ingelheim Investigational Site

Orthez, , France

Site Status

1218.46.3306E Boehringer Ingelheim Investigational Site

Orthez, , France

Site Status

1218.46.3306F Boehringer Ingelheim Investigational Site

Orthez, , France

Site Status

1218.46.3304E Boehringer Ingelheim Investigational Site

Pont-à-Mousson, , France

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1218.46.3302B Boehringer Ingelheim Investigational Site

Saint-Avertin, , France

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1218.46.3302C Boehringer Ingelheim Investigational Site

Saint-Avertin, , France

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1218.46.3303B Boehringer Ingelheim Investigational Site

Saint-Martin-d'Oney, , France

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1218.46.3306B Boehringer Ingelheim Investigational Site

Salies-de-Béarn, , France

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1218.46.3302E Boehringer Ingelheim Investigational Site

Savonnières, , France

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1218.46.3308A Boehringer Ingelheim Investigational Site

Strasbourg, , France

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1218.46.3308D Boehringer Ingelheim Investigational Site

Strasbourg, , France

Site Status

1218.46.3308E Boehringer Ingelheim Investigational Site

Strasbourg, , France

Site Status

1218.46.3307B Boehringer Ingelheim Investigational Site

Toulon, , France

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1218.46.3307C Boehringer Ingelheim Investigational Site

Toulon, , France

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1218.46.3307D Boehringer Ingelheim Investigational Site

Toulon, , France

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1218.46.3302A Boehringer Ingelheim Investigational Site

Tours, , France

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1218.46.3304H Boehringer Ingelheim Investigational Site

Vandœuvre-lès-Nancy, , France

Site Status

1218.46.49002 Boehringer Ingelheim Investigational Site

Bad Dürrheim-Sunthausen, , Germany

Site Status

1218.46.49001 Boehringer Ingelheim Investigational Site

Bad Mergentheim, , Germany

Site Status

1218.46.49006 Boehringer Ingelheim Investigational Site

Cologne, , Germany

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1218.46.49003 Boehringer Ingelheim Investigational Site

München, , Germany

Site Status

1218.46.49008 Boehringer Ingelheim Investigational Site

Neuwied, , Germany

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1218.46.49007 Boehringer Ingelheim Investigational Site

Schauenburg, , Germany

Site Status

1218.46.91009 Boehringer Ingelheim Investigational Site

Aurangabad, , India

Site Status

1218.46.91007 Boehringer Ingelheim Investigational Site

Babgalore, , India

Site Status

1218.46.91001 Boehringer Ingelheim Investigational Site

Bangalore, , India

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1218.46.91004 Boehringer Ingelheim Investigational Site

Bangalore, , India

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1218.46.91012 Boehringer Ingelheim Investigational Site

Bangalore, , India

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1218.46.91011 Boehringer Ingelheim Investigational Site

Bhopal, , India

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1218.46.91003 Boehringer Ingelheim Investigational Site

Chennai, , India

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1218.46.91020 Boehringer Ingelheim Investigational Site

Chennai, , India

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1218.46.91018 Boehringer Ingelheim Investigational Site

Hyderadad, , India

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1218.46.91008 Boehringer Ingelheim Investigational Site

Jaipur, , India

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1218.46.91019 Boehringer Ingelheim Investigational Site

Madurai, , India

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1218.46.91013 Boehringer Ingelheim Investigational Site

Maharashtra, , India

Site Status

1218.46.91002 Boehringer Ingelheim Investigational Site

Manipal, , India

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1218.46.91015 Boehringer Ingelheim Investigational Site

Mumbai, , India

Site Status

1218.46.91014 Boehringer Ingelheim Investigational Site

Nagpur, , India

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1218.46.91017 Boehringer Ingelheim Investigational Site

New Delhi, , India

Site Status

1218.46.91016 Boehringer Ingelheim Investigational Site

P.O Trivandrum, , India

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1218.46.91010 Boehringer Ingelheim Investigational Site

Pune, , India

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1218.46.91006 Boehringer Ingelheim Investigational Site

West Bengal, , India

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1218.46.37001 Boehringer Ingelheim Investigational Site

Kaunas, , Lithuania

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1218.46.37004 Boehringer Ingelheim Investigational Site

Kaunas, , Lithuania

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1218.46.37003 Boehringer Ingelheim Investigational Site

Vilnius, , Lithuania

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1218.46.52006 Boehringer Ingelheim Investigational Site

Aguascalientes, , Mexico

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1218.46.52002 Boehringer Ingelheim Investigational Site

Cuernavaca, , Mexico

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1218.46.52003 Boehringer Ingelheim Investigational Site

Guadalajara, , Mexico

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1218.46.52004 Boehringer Ingelheim Investigational Site

Guadalajara, , Mexico

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1218.46.52007 Boehringer Ingelheim Investigational Site

México, , Mexico

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1218.46.52008 Boehringer Ingelheim Investigational Site

México, , Mexico

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1218.46.52001 Boehringer Ingelheim Investigational Site

Pachuca, , Mexico

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1218.46.52010 Boehringer Ingelheim Investigational Site

Tijuana, , Mexico

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1218.46.52009 Boehringer Ingelheim Investigational Site

Veracruz, , Mexico

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1218.46.31004 Boehringer Ingelheim Investigational Site

's-Hertogenbosch, , Netherlands

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1218.46.31005 Boehringer Ingelheim Investigational Site

's-Hertogenbosch, , Netherlands

Site Status

1218.46.31001 Boehringer Ingelheim Investigational Site

Almere Stad, , Netherlands

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1218.46.31008 Boehringer Ingelheim Investigational Site

Beek, , Netherlands

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1218.46.31002 Boehringer Ingelheim Investigational Site

Beek en Donk, , Netherlands

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1218.46.31010 Boehringer Ingelheim Investigational Site

Breda, , Netherlands

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1218.46.31011 Boehringer Ingelheim Investigational Site

Eindhoven, , Netherlands

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1218.46.31013 Boehringer Ingelheim Investigational Site

Groningen, , Netherlands

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1218.46.31012 Boehringer Ingelheim Investigational Site

Leiderdrop, , Netherlands

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1218.46.31016 Boehringer Ingelheim Investigational Site

Nijmegen, , Netherlands

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1218.46.31009 Boehringer Ingelheim Investigational Site

Rotterdam, , Netherlands

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1218.46.31014 Boehringer Ingelheim Investigational Site

Velp, , Netherlands

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1218.46.31015 Boehringer Ingelheim Investigational Site

Zoetermeer, , Netherlands

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1218.46.40001 Boehringer Ingelheim Investigational Site

Alba Iulia, , Romania

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1218.46.40005 Boehringer Ingelheim Investigational Site

Galati, , Romania

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1218.46.40003 Boehringer Ingelheim Investigational Site

Oradea, , Romania

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1218.46.40002 Boehringer Ingelheim Investigational Site

Ploieşti, , Romania

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1218.46.40004 Boehringer Ingelheim Investigational Site

Satu Mare, , Romania

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1218.46.70001 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1218.46.70002 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1218.46.70003 Boehringer Ingelheim Investigational Site

Moscow, , Russia

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1218.46.70004 Boehringer Ingelheim Investigational Site

Moscow, , Russia

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1218.46.70006 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1218.46.70008 Boehringer Ingelheim Investigational Site

Moscow, , Russia

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1218.46.70005 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

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1218.46.70007 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

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1218.46.46002 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

Site Status

1218.46.46004 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

Site Status

1218.46.46003 Boehringer Ingelheim Investigational Site

Malmo, , Sweden

Site Status

1218.46.46005 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1218.46.46001 Boehringer Ingelheim Investigational Site

Uppsala, , Sweden

Site Status

1218.46.2162A Boehringer Ingelheim Investigational Site

Bab Sâadoun Tunis, , Tunisia

Site Status

1218.46.2161A Boehringer Ingelheim Investigational Site

Tunis, , Tunisia

Site Status

1218.46.2161B Boehringer Ingelheim Investigational Site

Tunis, , Tunisia

Site Status

1218.46.2163A Boehringer Ingelheim Investigational Site

Tunis, , Tunisia

Site Status

1218.46.2163B Boehringer Ingelheim Investigational Site

Tunis, , Tunisia

Site Status

1218.46.38003 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1218.46.38001 Boehringer Ingelheim Investigational Site

Lviv, , Ukraine

Site Status

1218.46.38005 Boehringer Ingelheim Investigational Site

Lviv, , Ukraine

Site Status

1218.46.38002 Boehringer Ingelheim Investigational Site

Odesa, , Ukraine

Site Status

1218.46.38004 Boehringer Ingelheim Investigational Site

Odesa, , Ukraine

Site Status

1218.46.38006 Boehringer Ingelheim Investigational Site

Vinnitsa, , Ukraine

Site Status

Countries

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Canada Croatia Estonia France Germany India Lithuania Mexico Netherlands Romania Russia Sweden Tunisia Ukraine

References

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Lv Q, Shen J, Miao L, Ye B, Schepers C, Plat A, Shi Y. Early Combination Therapy with Linagliptin and Metformin in People with Type 2 Diabetes Improves Glycemic Control to HbA1c </= 6.5% without Increasing Hypoglycemia: Pooled Analysis of Two Randomized Clinical Trials. Diabetes Ther. 2020 Jun;11(6):1317-1330. doi: 10.1007/s13300-020-00819-9. Epub 2020 Apr 23.

Reference Type DERIVED
PMID: 32328953 (View on PubMed)

Other Identifiers

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2008-001640-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1218.46

Identifier Type: -

Identifier Source: org_study_id

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