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

NCT00798161 | Completed Phase 3 Results

• 2 other identifiers: 1218.462008-001640-40
• Study Type: interventional
• Target: 857
• Locations: 14 countries
• Sites: 138

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c Change From Baseline at Week 24

  HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

  Baseline and week 24

Secondary Outcomes (17)

• HbA1c Change From Baseline at Week 6

  Baseline and week 6

• HbA1c Change From Baseline at Week 12

  Baseline and week 12

• HbA1c Change From Baseline at Week 18

  Baseline and week 18

• FPG Change From Baseline at Week 24

  Baseline and week 24

• FPG Change From Baseline at Week 2

  Baseline and week 2

Study Arms (6)

BI 1356 + metformin

EXPERIMENTAL

BI 1356 low dose + metformin 500 mg, twice daily

Drug: BI 1356 + metformin

matching placebo

PLACEBO COMPARATOR

matching placebo

Drug: matching placebo

BI 1356+ Metformin

EXPERIMENTAL

BI 1356 low dose + metformin 1000 mg, twice daily

Drug: Bi 1356 + metformin

Metformin

ACTIVE COMPARATOR

Metformin 500 mg, twice daily

Drug: Metformin

metformin

ACTIVE COMPARATOR

Metformin 1000 mg, twice daily

Drug: metformin

BI 1356

EXPERIMENTAL

BI 1356 high dose, once daily

Drug: BI 1356

Interventions

BI 1356 DRUG

BI 1356 high dose tablet, once daily

BI 1356

Bi 1356 + metformin DRUG

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

BI 1356 + metformin

metformin DRUG

Metformin 500 mg tablet, twice daily

Metformin

matching placebo DRUG

matching placebo

matching placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (138)

1218.46.11005 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Location

1218.46.11003 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Location

1218.46.11002 Boehringer Ingelheim Investigational Site

Red Deer, Alberta, Canada

Location

1218.46.11006 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1218.46.11008 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Location

1218.46.11004 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1218.46.11007 Boehringer Ingelheim Investigational Site

Oakville, Ontario, Canada

Location

1218.46.11009 Boehringer Ingelheim Investigational Site

Oshawa, Ontario, Canada

Location

1218.46.11010 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1218.46.38502 Boehringer Ingelheim Investigational Site

Karlovac, Croatia

Location

1218.46.38503 Boehringer Ingelheim Investigational Site

Krapinske Toplice, Croatia

Location

1218.46.38504 Boehringer Ingelheim Investigational Site

Osijek, Croatia

Location

1218.46.38505 Boehringer Ingelheim Investigational Site

Rijeka, Croatia

Location

1218.46.38501 Boehringer Ingelheim Investigational Site

Sisak, Croatia

Location

1218.46.38506 Boehringer Ingelheim Investigational Site

Zagreb, Croatia

Location

1218.46.37202 Boehringer Ingelheim Investigational Site

Pärnu, Estonia

Location

1218.46.37201 Boehringer Ingelheim Investigational Site

Tallinn, Estonia

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1218.46.37203 Boehringer Ingelheim Investigational Site

Tallinn, Estonia

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1218.46.3303D Boehringer Ingelheim Investigational Site

Aire Sur l'Aadour, France

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1218.46.3308B Boehringer Ingelheim Investigational Site

Bischheim, France

Location

1218.46.3305A Boehringer Ingelheim Investigational Site

Bourges, France

Location

1218.46.3304F Boehringer Ingelheim Investigational Site

Bousse, France

Location

1218.46.3306D Boehringer Ingelheim Investigational Site

Carresse-Cassaber, France

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1218.46.3308C Boehringer Ingelheim Investigational Site

Gambsheim, France

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1218.46.3305D Boehringer Ingelheim Investigational Site

Garchizy, France

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1218.46.3301A Boehringer Ingelheim Investigational Site

Grenoble Cédex, France

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1218.46.3305B Boehringer Ingelheim Investigational Site

Guérigny, France

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1218.46.3304A Boehringer Ingelheim Investigational Site

Jarny, France

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1218.46.3302D Boehringer Ingelheim Investigational Site

La Riche, France

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1218.46.3307A Boehringer Ingelheim Investigational Site

La Seyne-sur-Mer, France

Location

1218.46.3307E Boehringer Ingelheim Investigational Site

La Seyne-sur-Mer, France

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1218.46.3305G Boehringer Ingelheim Investigational Site

Lury-sur-Arnon, France

Location

1218.46.3304D Boehringer Ingelheim Investigational Site

Mars-la-Tour, France

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1218.46.3304B Boehringer Ingelheim Investigational Site

Mondelange, France

Location

1218.46.3303A Boehringer Ingelheim Investigational Site

Mont-de-Marsan, France

Location

1218.46.3303C Boehringer Ingelheim Investigational Site

Mont-de-Marsan, France

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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

Location

1218.46.3306A Boehringer Ingelheim Investigational Site

Orthez, France

Location

1218.46.3306C Boehringer Ingelheim Investigational Site

Orthez, France

Location

1218.46.3306E Boehringer Ingelheim Investigational Site

Orthez, France

Location

1218.46.3306F Boehringer Ingelheim Investigational Site

Orthez, France

Location

1218.46.3304E Boehringer Ingelheim Investigational Site

Pont-à-Mousson, France

Location

1218.46.3302B Boehringer Ingelheim Investigational Site

Saint-Avertin, France

Location

1218.46.3302C Boehringer Ingelheim Investigational Site

Saint-Avertin, France

Location

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

Location

1218.46.3302E Boehringer Ingelheim Investigational Site

Savonnières, France

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1218.46.3308A Boehringer Ingelheim Investigational Site

Strasbourg, France

Location

1218.46.3308D Boehringer Ingelheim Investigational Site

Strasbourg, France

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1218.46.3308E Boehringer Ingelheim Investigational Site

Strasbourg, France

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1218.46.3307B Boehringer Ingelheim Investigational Site

Toulon, France

Location

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

Location

1218.46.3304H Boehringer Ingelheim Investigational Site

Vandœuvre-lès-Nancy, France

Location

1218.46.49002 Boehringer Ingelheim Investigational Site

Bad Dürrheim-Sunthausen, Germany

Location

1218.46.49001 Boehringer Ingelheim Investigational Site

Bad Mergentheim, Germany

Location

1218.46.49006 Boehringer Ingelheim Investigational Site

Cologne, Germany

Location

1218.46.49003 Boehringer Ingelheim Investigational Site

München, Germany

Location

1218.46.49008 Boehringer Ingelheim Investigational Site

Neuwied, Germany

Location

1218.46.49007 Boehringer Ingelheim Investigational Site

Schauenburg, Germany

Location

1218.46.91009 Boehringer Ingelheim Investigational Site

Aurangabad, India

Location

1218.46.91007 Boehringer Ingelheim Investigational Site

Babgalore, India

Location

1218.46.91001 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1218.46.91004 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1218.46.91012 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1218.46.91011 Boehringer Ingelheim Investigational Site

Bhopal, India

Location

1218.46.91003 Boehringer Ingelheim Investigational Site

Chennai, India

Location

1218.46.91020 Boehringer Ingelheim Investigational Site

Chennai, India

Location

1218.46.91018 Boehringer Ingelheim Investigational Site

Hyderadad, India

Location

1218.46.91008 Boehringer Ingelheim Investigational Site

Jaipur, India

Location

1218.46.91019 Boehringer Ingelheim Investigational Site

Madurai, India

Location

1218.46.91013 Boehringer Ingelheim Investigational Site

Maharashtra, India

Location

1218.46.91002 Boehringer Ingelheim Investigational Site

Manipal, India

Location

1218.46.91015 Boehringer Ingelheim Investigational Site

Mumbai, India

Location

1218.46.91014 Boehringer Ingelheim Investigational Site

Nagpur, India

Location

1218.46.91017 Boehringer Ingelheim Investigational Site

New Delhi, India

Location

1218.46.91016 Boehringer Ingelheim Investigational Site

P.O Trivandrum, India

Location

1218.46.91010 Boehringer Ingelheim Investigational Site

Pune, India

Location

1218.46.91006 Boehringer Ingelheim Investigational Site

West Bengal, India

Location

1218.46.37001 Boehringer Ingelheim Investigational Site

Kaunas, Lithuania

Location

1218.46.37004 Boehringer Ingelheim Investigational Site

Kaunas, Lithuania

Location

1218.46.37003 Boehringer Ingelheim Investigational Site

Vilnius, Lithuania

Location

1218.46.52006 Boehringer Ingelheim Investigational Site

Aguascalientes, Mexico

Location

1218.46.52002 Boehringer Ingelheim Investigational Site

Cuernavaca, Mexico

Location

1218.46.52003 Boehringer Ingelheim Investigational Site

Guadalajara, Mexico

Location

1218.46.52004 Boehringer Ingelheim Investigational Site

Guadalajara, Mexico

Location

1218.46.52007 Boehringer Ingelheim Investigational Site

México, Mexico

Location

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

Location

1218.46.31005 Boehringer Ingelheim Investigational Site

's-Hertogenbosch, Netherlands

Location

1218.46.31001 Boehringer Ingelheim Investigational Site

Almere Stad, Netherlands

Location

1218.46.31008 Boehringer Ingelheim Investigational Site

Beek, Netherlands

Location

1218.46.31002 Boehringer Ingelheim Investigational Site

Beek en Donk, Netherlands

Location

1218.46.31010 Boehringer Ingelheim Investigational Site

Breda, Netherlands

Location

1218.46.31011 Boehringer Ingelheim Investigational Site

Eindhoven, Netherlands

Location

1218.46.31013 Boehringer Ingelheim Investigational Site

Groningen, Netherlands

Location

1218.46.31012 Boehringer Ingelheim Investigational Site

Leiderdrop, Netherlands

Location

1218.46.31016 Boehringer Ingelheim Investigational Site

Nijmegen, Netherlands

Location

1218.46.31009 Boehringer Ingelheim Investigational Site

Rotterdam, Netherlands

Location

1218.46.31014 Boehringer Ingelheim Investigational Site

Velp, Netherlands

Location

1218.46.31015 Boehringer Ingelheim Investigational Site

Zoetermeer, Netherlands

Location

1218.46.40001 Boehringer Ingelheim Investigational Site

Alba Iulia, Romania

Location

1218.46.40005 Boehringer Ingelheim Investigational Site

Galati, Romania

Location

1218.46.40003 Boehringer Ingelheim Investigational Site

Oradea, Romania

Location

1218.46.40002 Boehringer Ingelheim Investigational Site

Ploieşti, Romania

Location

1218.46.40004 Boehringer Ingelheim Investigational Site

Satu Mare, Romania

Location

1218.46.70001 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.46.70002 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.46.70003 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.46.70004 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.46.70006 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.46.70008 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.46.70005 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1218.46.70007 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1218.46.46002 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1218.46.46004 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1218.46.46003 Boehringer Ingelheim Investigational Site

Malmo, Sweden

Location

1218.46.46005 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1218.46.46001 Boehringer Ingelheim Investigational Site

Uppsala, Sweden

Location

1218.46.2162A Boehringer Ingelheim Investigational Site

Bab Sâadoun Tunis, Tunisia

Location

1218.46.2161A Boehringer Ingelheim Investigational Site

Tunis, Tunisia

Location

1218.46.2161B Boehringer Ingelheim Investigational Site

Tunis, Tunisia

Location

1218.46.2163A Boehringer Ingelheim Investigational Site

Tunis, Tunisia

Location

1218.46.2163B Boehringer Ingelheim Investigational Site

Tunis, Tunisia

Location

1218.46.38003 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1218.46.38001 Boehringer Ingelheim Investigational Site

Lviv, Ukraine

Location

1218.46.38005 Boehringer Ingelheim Investigational Site

Lviv, Ukraine

Location

1218.46.38002 Boehringer Ingelheim Investigational Site

Odesa, Ukraine

Location

1218.46.38004 Boehringer Ingelheim Investigational Site

Odesa, Ukraine

Location

1218.46.38006 Boehringer Ingelheim Investigational Site

Vinnitsa, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 32328953 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Linagliptin; Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines; Biguanides; Guanidines; Amidines; Organic Chemicals

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: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 25, 2008
• Study Start: December 1, 2008
• Primary Completion: May 1, 2010
• Last Updated: January 28, 2014
• Results First Posted: August 4, 2011

Record last verified: 2013-12

Locations

NL (13); RO (5); TU (5); CA (9); DE (6); ME (9); CR (6); FR (41); ES (3); RU (8); SE (5); UA (6); LI (3); IN (19)