Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes

NCT00954447 | Completed Phase 3 Results

• 2 other identifiers: 1218.362008-008296-33
• Study Type: interventional
• Target: 1,263
• Locations: 19 countries
• Sites: 169

Brief Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c After 24 Weeks

  HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)

  Baseline and 24 weeks

Secondary Outcomes (14)

• Number of Patients With HbA1c < 7.0 Percent

  24 and 52 weeks

• Number of Patients Lowering HbA1c by at Least 0.5 Percent

  24 and 52 weeks

• Change From Baseline in HbA1c by Visit at Week 6

  Baseline and 6 weeks

• Change From Baseline in HbA1c by Visit at Week 12

  Baseline and 12 weeks

• Change From Baseline in HbA1c by Visit at Week 18

  Baseline and 18 weeks

Other Outcomes (1)

• Number of Patients With HbA1c < 6.5 Percent

  24 and 52 weeks

Study Arms (2)

Linagliptin

EXPERIMENTAL

patient receives a tablet with intended final marketed dose

Drug: Linagliptin

Placebo

PLACEBO COMPARATOR

patient receives a tablet identical to those containing Linagliptin

Drug: Placebo

Interventions

Placebo DRUG

Placebo, identical to Linagliptin tablet

Placebo

Linagliptin DRUG

intended final marketed dose

Linagliptin

Eligibility Criteria

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

You may qualify if:

• Diabetes type 2, detectable C-peptide, HbA1c 7-10%
• Pretreatment with basal insulin +/- Metformin or/and +/- Pioglitazone 3 Age \> 18 years, BMI \<= 45 kg/m2

You may not qualify if:

• Uncontrolled hyperglycemia during Run-in
• Myocardial infarction, stroke or TIA within 3 months prior to informed consent
• Liver impairment; gastric surgery; medical history of cancer in last 5 years
• Other antidiabetic drugs, antiobesity drugs, systemic steroids, other investigational drug before randomisation
• Unsufficient birth control, pregnancy and nursing

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Eli Lilly and Company: collaborator

Study Sites (169)

1218.36.01043 Boehringer Ingelheim Investigational Site

Escondido, California, United States

Location

1218.36.01051 Boehringer Ingelheim Investigational Site

Escondido, California, United States

Location

1218.36.01065 Boehringer Ingelheim Investigational Site

Fresno, California, United States

Location

1218.36.01021 Boehringer Ingelheim Investigational Site

Greenbrae, California, United States

Location

1218.36.01013 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1218.36.01048 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1218.36.01058 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

1218.36.01008 Boehringer Ingelheim Investigational Site

Santa Ana, California, United States

Location

1218.36.01056 Boehringer Ingelheim Investigational Site

Waterbury, Connecticut, United States

Location

1218.36.01054 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Location

1218.36.01035 Boehringer Ingelheim Investigational Site

Inverness, Florida, United States

Location

1218.36.01010 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1218.36.01042 Boehringer Ingelheim Investigational Site

New Port Richey, Florida, United States

Location

1218.36.01063 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Location

1218.36.01037 Boehringer Ingelheim Investigational Site

Ponte Vedra, Florida, United States

Location

1218.36.01032 Boehringer Ingelheim Investigational Site

Saint Cloud, Florida, United States

Location

1218.36.01049 Boehringer Ingelheim Investigational Site

St. Petersburg, Florida, United States

Location

1218.36.01036 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

1218.36.01047 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

Location

1218.36.01009 Boehringer Ingelheim Investigational Site

Roswell, Georgia, United States

Location

1218.36.01055 Boehringer Ingelheim Investigational Site

Honolulu, Hawaii, United States

Location

1218.36.01014 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1218.36.01011 Boehringer Ingelheim Investigational Site

Paducah, Kentucky, United States

Location

1218.36.01034 Boehringer Ingelheim Investigational Site

City of Saint Peters, Missouri, United States

Location

1218.36.01040 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Location

1218.36.01029 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

1218.36.01018 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Location

1218.36.01053 Boehringer Ingelheim Investigational Site

New Hartford, New York, United States

Location

1218.36.01006 Boehringer Ingelheim Investigational Site

Burlington, North Carolina, United States

Location

1218.36.01025 Boehringer Ingelheim Investigational Site

Hickory, North Carolina, United States

Location

1218.36.01005 Boehringer Ingelheim Investigational Site

Statesville, North Carolina, United States

Location

1218.36.01015 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

1218.36.01039 Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

Location

1218.36.01019 Boehringer Ingelheim Investigational Site

Altoona, Pennsylvania, United States

Location

1218.36.01012 Boehringer Ingelheim Investigational Site

Norristown, Pennsylvania, United States

Location

1218.36.01004 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

Location

1218.36.01020 Boehringer Ingelheim Investigational Site

Simpsonville, South Carolina, United States

Location

1218.36.01003 Boehringer Ingelheim Investigational Site

Kingsport, Tennessee, United States

Location

1218.36.01038 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1218.36.01016 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1218.36.01026 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Location

1218.36.01041 Boehringer Ingelheim Investigational Site

Bennington, Vermont, United States

Location

1218.36.01064 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

1218.36.01024 Boehringer Ingelheim Investigational Site

Lakewood, Washington, United States

Location

1218.36.01007 Boehringer Ingelheim Investigational Site

Renton, Washington, United States

Location

1218.36.01027 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Location

1218.36.01062 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Location

1218.36.54001 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1218.36.54002 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1218.36.54003 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1218.36.54005 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1218.36.54004 Boehringer Ingelheim Investigational Site

Córdoba, Argentina

Location

1218.36.32002 Boehringer Ingelheim Investigational Site

Edegem, Belgium

Location

1218.36.320099 Boehringer Ingelheim Investigational Site

Edegem, Belgium

Location

1218.36.32006 Boehringer Ingelheim Investigational Site

Sint-Gillis-Waas, Belgium

Location

1218.36.55003 Boehringer Ingelheim Investigational Site

Belém, Brazil

Location

1218.36.55004 Boehringer Ingelheim Investigational Site

Porto Alegre, Brazil

Location

1218.36.55001 Boehringer Ingelheim Investigational Site

São Paulo, Brazil

Location

1218.36.55002 Boehringer Ingelheim Investigational Site

São Paulo, Brazil

Location

1218.36.02010 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Location

1218.36.02004 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1218.36.02011 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

Location

1218.36.02006 Boehringer Ingelheim Investigational Site

St. John's, Newfoundland and Labrador, Canada

Location

1218.36.02002 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

Location

1218.36.02009 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1218.36.02005 Boehringer Ingelheim Investigational Site

Kingston, Ontario, Canada

Location

1218.36.02008 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Location

1218.36.02007 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1218.36.02001 Boehringer Ingelheim Investigational Site

Laval, Quebec, Canada

Location

1218.36.02003 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1218.36.42004 Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

1218.36.42006 Boehringer Ingelheim Investigational Site

Břeclav, Czechia

Location

1218.36.42005 Boehringer Ingelheim Investigational Site

Hodonín, Czechia

Location

1218.36.42002 Boehringer Ingelheim Investigational Site

Mladá Boleslav, Czechia

Location

1218.36.42001 Boehringer Ingelheim Investigational Site

Neratovice, Czechia

Location

1218.36.42007 Boehringer Ingelheim Investigational Site

Zlín, Czechia

Location

1218.36.35807 Boehringer Ingelheim Investigational Site

Joensuu, Finland

Location

1218.36.35802 Boehringer Ingelheim Investigational Site

Kuopio, Finland

Location

1218.36.35803 Boehringer Ingelheim Investigational Site

Oulu, Finland

Location

1218.36.35805 Boehringer Ingelheim Investigational Site

Tampere, Finland

Location

1218.36.35804 Boehringer Ingelheim Investigational Site

Turku, Finland

Location

1218.36.35806 Boehringer Ingelheim Investigational Site

Vantaa, Finland

Location

1218.36.49001 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1218.36.49002 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1218.36.49010 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1218.36.49009 Boehringer Ingelheim Investigational Site

Bosenheim, Germany

Location

1218.36.49017 Boehringer Ingelheim Investigational Site

Cologne, Germany

Location

1218.36.49004 Boehringer Ingelheim Investigational Site

Dortmund, Germany

Location

1218.36.49006 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

1218.36.49012 Boehringer Ingelheim Investigational Site

Magdeburg, Germany

Location

1218.36.49005 Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

1218.36.49018 Boehringer Ingelheim Investigational Site

Neuwied, Germany

Location

1218.36.49008 Boehringer Ingelheim Investigational Site

Pirna, Germany

Location

1218.36.49019 Boehringer Ingelheim Investigational Site

Sulzbach-Rosenberg, Germany

Location

1218.36.49003 Boehringer Ingelheim Investigational Site

Unterschneidheim, Germany

Location

1218.36.49011 Boehringer Ingelheim Investigational Site

Wangen, Germany

Location

1218.36.49014 Boehringer Ingelheim Investigational Site

Wangen, Germany

Location

1218.36.49015 Boehringer Ingelheim Investigational Site

Westerkappeln, Germany

Location

1218.36.30003 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1218.36.30007 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1218.36.30010 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1218.36.30011 Boehringer Ingelheim Investigational Site

Larissa, Greece

Location

1218.36.30002 Boehringer Ingelheim Investigational Site

Nikaia, Greece

Location

1218.36.30005 Boehringer Ingelheim Investigational Site

Thessaloniki, Greece

Location

1218.36.39002 Boehringer Ingelheim Investigational Site

Ferrara, Italy

Location

1218.36.39003 Boehringer Ingelheim Investigational Site

Ferrara, Italy

Location

1218.36.39004 Boehringer Ingelheim Investigational Site

Genova, Italy

Location

1218.36.39005 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

1218.36.39001 Boehringer Ingelheim Investigational Site

Pordenone, Italy

Location

1218.36.39007 Boehringer Ingelheim Investigational Site

Siena, Italy

Location

1218.36.39006 Boehringer Ingelheim Investigational Site

Syracuse, Italy

Location

1218.36.52002 Boehringer Ingelheim Investigational Site

Pachuca, Mexico

Location

1218.36.52004 Boehringer Ingelheim Investigational Site

San Luis Potosí City, Mexico

Location

1218.36.52005 Boehringer Ingelheim Investigational Site

Tijuana, Mexico

Location

1218.36.31008 Boehringer Ingelheim Investigational Site

's-Hertogenbosch, Netherlands

Location

1218.36.31001 Boehringer Ingelheim Investigational Site

Almere Stad, Netherlands

Location

1218.36.31006 Boehringer Ingelheim Investigational Site

Beek, Netherlands

Location

1218.36.31002 Boehringer Ingelheim Investigational Site

Ewijk, Netherlands

Location

1218.36.31004 Boehringer Ingelheim Investigational Site

Oude Pekela, Netherlands

Location

1218.36.31007 Boehringer Ingelheim Investigational Site

Roelofarendsveen, Netherlands

Location

1218.36.31005 Boehringer Ingelheim Investigational Site

Wildervank, Netherlands

Location

1218.36.47002 Boehringer Ingelheim Investigational Site

Bergen, Norway

Location

1218.36.47006 Boehringer Ingelheim Investigational Site

Elverum, Norway

Location

1218.36.47005 Boehringer Ingelheim Investigational Site

Hamar, Norway

Location

1218.36.47004 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

1218.36.47001 Boehringer Ingelheim Investigational Site

Stavanger, Norway

Location

1218.36.51003 Boehringer Ingelheim Investigational Site

Lima, Peru

Location

1218.36.70002 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.36.70003 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.36.70005 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1218.36.70001 Boehringer Ingelheim Investigational Site

Samara, Russia

Location

1218.36.70007 Boehringer Ingelheim Investigational Site

Smolensk, Russia

Location

1218.36.70006 Boehringer Ingelheim Investigational Site

Yaroslavl, Russia

Location

1218.36.42103 Boehringer Ingelheim Investigational Site

Banská Bystrica, Slovakia

Location

1218.36.42101 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

1218.36.42102 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

1218.36.42104 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

1218.36.42105 Boehringer Ingelheim Investigational Site

Prešov, Slovakia

Location

1218.36.42106 Boehringer Ingelheim Investigational Site

Trebišov, Slovakia

Location

1218.36.82004 Boehringer Ingelheim Investigational Site

Daegu, South Korea

Location

1218.36.82009 Boehringer Ingelheim Investigational Site

Daegu, South Korea

Location

1218.36.82008 Boehringer Ingelheim Investigational Site

Incheon, South Korea

Location

1218.36.82007 Boehringer Ingelheim Investigational Site

Jeonju, South Korea

Location

1218.36.82001 Boehringer Ingelheim Investigational Site

Pusan, South Korea

Location

1218.36.82002 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1218.36.82003 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1218.36.82005 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1218.36.82006 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1218.36.82010 Boehringer Ingelheim Investigational Site

Suwon, South Korea

Location

1218.36.34002 Boehringer Ingelheim Investigational Site

Badia Del Vallés (Barcelona), Spain

Location

1218.36.34005 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1218.36.34010 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1218.36.34001 Boehringer Ingelheim Investigational Site

Bercelona, Spain

Location

1218.36.34007 Boehringer Ingelheim Investigational Site

Borges Del Camp (Tarragona), Spain

Location

1218.36.34003 Boehringer Ingelheim Investigational Site

Centelles (Barcelona), Spain

Location

1218.36.34004 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat (Barcelona), Spain

Location

1218.36.34011 Boehringer Ingelheim Investigational Site

Seville, Spain

Location

1218.36.34009 Boehringer Ingelheim Investigational Site

Tàrrega (Lleida), Spain

Location

1218.36.34006 Boehringer Ingelheim Investigational Site

Vic (Barcelona), Spain

Location

1218.36.88610 Boehringer Ingelheim Investigational Site

Changhua, Taiwan

Location

1218.36.88607 Boehringer Ingelheim Investigational Site

Kaohsiung City, Taiwan

Location

1218.36.88601 Boehringer Ingelheim Investigational Site

Taichung, Taiwan

Location

1218.36.88603 Boehringer Ingelheim Investigational Site

Taichung, Taiwan

Location

1218.36.88606 Boehringer Ingelheim Investigational Site

Tainan, Taiwan

Location

1218.36.88602 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1218.36.88604 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1218.36.88605 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1218.36.88608 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1218.36.88609 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

Related Publications (2)

• Sheu WH, Park SW, Gong Y, Pinnetti S, Bhattacharya S, Patel S, Seck T, Woerle HJ. Linagliptin improves glycemic control after 1 year as add-on therapy to basal insulin in Asian patients with type 2 diabetes mellitus. Curr Med Res Opin. 2015 Mar;31(3):503-12. doi: 10.1185/03007995.2015.1010638. Epub 2015 Feb 13.

  PMID: 25629790 DERIVED

• Yki-Jarvinen H, Rosenstock J, Duran-Garcia S, Pinnetti S, Bhattacharya S, Thiemann S, Patel S, Woerle HJ. Effects of adding linagliptin to basal insulin regimen for inadequately controlled type 2 diabetes: a >/=52-week randomized, double-blind study. Diabetes Care. 2013 Dec;36(12):3875-81. doi: 10.2337/dc12-2718. Epub 2013 Sep 23.

  PMID: 24062327 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Linagliptin

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

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2009
• First Posted: August 7, 2009
• Study Start: August 1, 2009
• Primary Completion: September 1, 2011
• Last Updated: December 30, 2013
• Results First Posted: September 27, 2012

Record last verified: 2012-10

Locations

BR (4); CZ (6); NL (7); KR (10); TW (10); CA (11); ME (3); US (47); BE (3); DE (16); ES (10); FI (6); IT (7); NO (5); PE (1); RU (6); GR (6); SL (6); AR (5)