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NCT00954447 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group Efficacy and Safety Study of Linagliptin (5 mg), Administered Orally Once Daily for at Least 52 Weeks in Type 2 Diabetic Patients in Combination With Basal Insulin Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00954447
Other study ID # 1218.36
Secondary ID 2008-008296-33
Status Completed
Phase Phase 3
First received August 6, 2009
Last updated December 4, 2013
Start date August 2009

Study information
Verified date October 2012
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia MedicaBelgium: Federal Agency for Medicinal and Health ProductsBrazil: National Health Surveillance AgencyCanada: Health CanadaCzech Republic: State Institute for Drug ControlFinland: Finnish Medicines AgencyGermany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, D-53175 BonnGreece: Ethics CommitteeItaly: Ethics CommitteeKorea: Food and Drug AdministrationMexico: Federal Commission for Protection Against Health RisksNetherlands: Central Committee Research Involving Human SubjectsNorway: Norwegian Medicines AgencyPeru: Ministry of HealthRussia: Pharmacological Committee, Ministry of HealthSlovakia: State Institute for Drug ControlSpain: Ministry of HealthTaiwan: Department of HealthUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1263
Est. completion date
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

1. Diabetes type 2, detectable C-peptide, HbA1c 7-10%

2. Pretreatment with basal insulin +/- Metformin or/and +/- Pioglitazone 3 Age > 18 years, BMI <= 45 kg/m2

Exclusion criteria:

1. Uncontrolled hyperglycemia during Run-in

2. Myocardial infarction, stroke or TIA within 3 months prior to informed consent

3. Liver impairment; gastric surgery; medical history of cancer in last 5 years

4. Other antidiabetic drugs, antiobesity drugs, systemic steroids, other investigational drug before randomisation

5. Unsufficient birth control, pregnancy and nursing

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Placebo, identical to Linagliptin tablet
• Linagliptin
intended final marketed dose

Locations
Country Name City State
Argentina 1218.36.54001 Boehringer Ingelheim Investigational Site Capital Federal
Argentina 1218.36.54002 Boehringer Ingelheim Investigational Site Capital Federal
Argentina 1218.36.54003 Boehringer Ingelheim Investigational Site Capital Federal
Argentina 1218.36.54005 Boehringer Ingelheim Investigational Site Capital Federal
Argentina 1218.36.54004 Boehringer Ingelheim Investigational Site Córdoba
Belgium 1218.36.32002 Boehringer Ingelheim Investigational Site Edegem
Belgium 1218.36.320099 Boehringer Ingelheim Investigational Site Edegem
Belgium 1218.36.32006 Boehringer Ingelheim Investigational Site Sint-Gillis-Waas
Brazil 1218.36.55003 Boehringer Ingelheim Investigational Site Belém
Brazil 1218.36.55004 Boehringer Ingelheim Investigational Site Porto Alegre
Brazil 1218.36.55001 Boehringer Ingelheim Investigational Site São Paulo
Brazil 1218.36.55002 Boehringer Ingelheim Investigational Site São Paulo
Canada 1218.36.02010 Boehringer Ingelheim Investigational Site Calgary Alberta
Canada 1218.36.02002 Boehringer Ingelheim Investigational Site Halifax Nova Scotia
Canada 1218.36.02009 Boehringer Ingelheim Investigational Site Hamilton Ontario
Canada 1218.36.02005 Boehringer Ingelheim Investigational Site Kingston Ontario
Canada 1218.36.02001 Boehringer Ingelheim Investigational Site Laval Quebec
Canada 1218.36.02003 Boehringer Ingelheim Investigational Site Montreal Quebec
Canada 1218.36.02008 Boehringer Ingelheim Investigational Site Sarnia Ontario
Canada 1218.36.02006 Boehringer Ingelheim Investigational Site St. John's Newfoundland and Labrador
Canada 1218.36.02007 Boehringer Ingelheim Investigational Site Toronto Ontario
Canada 1218.36.02004 Boehringer Ingelheim Investigational Site Vancouver British Columbia
Canada 1218.36.02011 Boehringer Ingelheim Investigational Site Victoria British Columbia
Czech Republic 1218.36.42006 Boehringer Ingelheim Investigational Site Breclav
Czech Republic 1218.36.42004 Boehringer Ingelheim Investigational Site Brno
Czech Republic 1218.36.42005 Boehringer Ingelheim Investigational Site Hodonin
Czech Republic 1218.36.42002 Boehringer Ingelheim Investigational Site Mlada Boleslav
Czech Republic 1218.36.42001 Boehringer Ingelheim Investigational Site Neratovice
Czech Republic 1218.36.42007 Boehringer Ingelheim Investigational Site Zlin
Finland 1218.36.35807 Boehringer Ingelheim Investigational Site Joensuu
Finland 1218.36.35802 Boehringer Ingelheim Investigational Site Kuopio
Finland 1218.36.35803 Boehringer Ingelheim Investigational Site Oulu
Finland 1218.36.35805 Boehringer Ingelheim Investigational Site Tampere
Finland 1218.36.35804 Boehringer Ingelheim Investigational Site Turku
Finland 1218.36.35806 Boehringer Ingelheim Investigational Site Vantaa
Germany 1218.36.49001 Boehringer Ingelheim Investigational Site Berlin
Germany 1218.36.49002 Boehringer Ingelheim Investigational Site Berlin
Germany 1218.36.49010 Boehringer Ingelheim Investigational Site Berlin
Germany 1218.36.49009 Boehringer Ingelheim Investigational Site Bosenheim
Germany 1218.36.49004 Boehringer Ingelheim Investigational Site Dortmund
Germany 1218.36.49006 Boehringer Ingelheim Investigational Site Dresden
Germany 1218.36.49017 Boehringer Ingelheim Investigational Site Köln
Germany 1218.36.49012 Boehringer Ingelheim Investigational Site Magdeburg
Germany 1218.36.49005 Boehringer Ingelheim Investigational Site Mainz
Germany 1218.36.49018 Boehringer Ingelheim Investigational Site Neuwied
Germany 1218.36.49008 Boehringer Ingelheim Investigational Site Pirna
Germany 1218.36.49019 Boehringer Ingelheim Investigational Site Sulzbach-Rosenberg
Germany 1218.36.49003 Boehringer Ingelheim Investigational Site Unterschneidheim
Germany 1218.36.49011 Boehringer Ingelheim Investigational Site Wangen
Germany 1218.36.49014 Boehringer Ingelheim Investigational Site Wangen
Germany 1218.36.49015 Boehringer Ingelheim Investigational Site Westerkappeln
Greece 1218.36.30003 Boehringer Ingelheim Investigational Site Athens
Greece 1218.36.30007 Boehringer Ingelheim Investigational Site Athens
Greece 1218.36.30010 Boehringer Ingelheim Investigational Site Athens
Greece 1218.36.30011 Boehringer Ingelheim Investigational Site Larissa
Greece 1218.36.30002 Boehringer Ingelheim Investigational Site Nikaia
Greece 1218.36.30005 Boehringer Ingelheim Investigational Site Thessaloniki
Italy 1218.36.39002 Boehringer Ingelheim Investigational Site Ferrara
Italy 1218.36.39003 Boehringer Ingelheim Investigational Site Ferrara
Italy 1218.36.39004 Boehringer Ingelheim Investigational Site Genova
Italy 1218.36.39005 Boehringer Ingelheim Investigational Site Milano
Italy 1218.36.39001 Boehringer Ingelheim Investigational Site Pordenone
Italy 1218.36.39007 Boehringer Ingelheim Investigational Site Siena
Italy 1218.36.39006 Boehringer Ingelheim Investigational Site Siracusa
Korea, Republic of 1218.36.82004 Boehringer Ingelheim Investigational Site Daegu
Korea, Republic of 1218.36.82009 Boehringer Ingelheim Investigational Site Daegu
Korea, Republic of 1218.36.82008 Boehringer Ingelheim Investigational Site Incheon
Korea, Republic of 1218.36.82007 Boehringer Ingelheim Investigational Site Jeonju
Korea, Republic of 1218.36.82001 Boehringer Ingelheim Investigational Site Pusan
Korea, Republic of 1218.36.82002 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1218.36.82003 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1218.36.82005 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1218.36.82006 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1218.36.82010 Boehringer Ingelheim Investigational Site Suwon
Mexico 1218.36.52002 Boehringer Ingelheim Investigational Site Pachuca
Mexico 1218.36.52004 Boehringer Ingelheim Investigational Site San Luis Potosi
Mexico 1218.36.52005 Boehringer Ingelheim Investigational Site Tijuana
Netherlands 1218.36.31008 Boehringer Ingelheim Investigational Site 's Hertogenbosch
Netherlands 1218.36.31001 Boehringer Ingelheim Investigational Site Almere
Netherlands 1218.36.31006 Boehringer Ingelheim Investigational Site Beek
Netherlands 1218.36.31002 Boehringer Ingelheim Investigational Site Ewijk
Netherlands 1218.36.31004 Boehringer Ingelheim Investigational Site Oude Pekela
Netherlands 1218.36.31007 Boehringer Ingelheim Investigational Site Roelofarendsveen
Netherlands 1218.36.31005 Boehringer Ingelheim Investigational Site Wildervank
Norway 1218.36.47002 Boehringer Ingelheim Investigational Site Bergen
Norway 1218.36.47006 Boehringer Ingelheim Investigational Site Elverum
Norway 1218.36.47005 Boehringer Ingelheim Investigational Site Hamar
Norway 1218.36.47004 Boehringer Ingelheim Investigational Site Oslo
Norway 1218.36.47001 Boehringer Ingelheim Investigational Site Stavanger
Peru 1218.36.51003 Boehringer Ingelheim Investigational Site Lima
Russian Federation 1218.36.70002 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1218.36.70003 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1218.36.70001 Boehringer Ingelheim Investigational Site Samara
Russian Federation 1218.36.70007 Boehringer Ingelheim Investigational Site Smolensk
Russian Federation 1218.36.70005 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 1218.36.70006 Boehringer Ingelheim Investigational Site Yaroslavl
Slovakia 1218.36.42103 Boehringer Ingelheim Investigational Site Banska Bystrica
Slovakia 1218.36.42101 Boehringer Ingelheim Investigational Site Bratislava
Slovakia 1218.36.42102 Boehringer Ingelheim Investigational Site Bratislava
Slovakia 1218.36.42104 Boehringer Ingelheim Investigational Site Bratislava
Slovakia 1218.36.42105 Boehringer Ingelheim Investigational Site Presov
Slovakia 1218.36.42106 Boehringer Ingelheim Investigational Site Trebisov
Spain 1218.36.34002 Boehringer Ingelheim Investigational Site Badia del Vallés (Barcelona)
Spain 1218.36.34005 Boehringer Ingelheim Investigational Site Barcelona
Spain 1218.36.34010 Boehringer Ingelheim Investigational Site Barcelona
Spain 1218.36.34001 Boehringer Ingelheim Investigational Site Bercelona
Spain 1218.36.34007 Boehringer Ingelheim Investigational Site Borges del Camp (Tarragona)
Spain 1218.36.34003 Boehringer Ingelheim Investigational Site Centelles (Barcelona)
Spain 1218.36.34004 Boehringer Ingelheim Investigational Site L'Hospitalet de Llobregat (Barcelona)
Spain 1218.36.34011 Boehringer Ingelheim Investigational Site Sevilla
Spain 1218.36.34009 Boehringer Ingelheim Investigational Site Tàrrega (Lleida)
Spain 1218.36.34006 Boehringer Ingelheim Investigational Site Vic (Barcelona)
Taiwan 1218.36.88610 Boehringer Ingelheim Investigational Site Changhua
Taiwan 1218.36.88607 Boehringer Ingelheim Investigational Site Kaohsiung
Taiwan 1218.36.88601 Boehringer Ingelheim Investigational Site Taichung
Taiwan 1218.36.88603 Boehringer Ingelheim Investigational Site Taichung
Taiwan 1218.36.88606 Boehringer Ingelheim Investigational Site Tainan
Taiwan 1218.36.88602 Boehringer Ingelheim Investigational Site Taipei
Taiwan 1218.36.88604 Boehringer Ingelheim Investigational Site Taipei
Taiwan 1218.36.88605 Boehringer Ingelheim Investigational Site Taipei
Taiwan 1218.36.88608 Boehringer Ingelheim Investigational Site Taipei
Taiwan 1218.36.88609 Boehringer Ingelheim Investigational Site Taipei City
United States 1218.36.01019 Boehringer Ingelheim Investigational Site Altoona Pennsylvania
United States 1218.36.01036 Boehringer Ingelheim Investigational Site Atlanta Georgia
United States 1218.36.01041 Boehringer Ingelheim Investigational Site Bennington Vermont
United States 1218.36.01006 Boehringer Ingelheim Investigational Site Burlington North Carolina
United States 1218.36.01014 Boehringer Ingelheim Investigational Site Chicago Illinois
United States 1218.36.01015 Boehringer Ingelheim Investigational Site Cincinnati Ohio
United States 1218.36.01054 Boehringer Ingelheim Investigational Site Clearwater Florida
United States 1218.36.01038 Boehringer Ingelheim Investigational Site Dallas Texas
United States 1218.36.01047 Boehringer Ingelheim Investigational Site Decatur Georgia
United States 1218.36.01043 Boehringer Ingelheim Investigational Site Escondido California
United States 1218.36.01051 Boehringer Ingelheim Investigational Site Escondido California
United States 1218.36.01065 Boehringer Ingelheim Investigational Site Fresno California
United States 1218.36.01021 Boehringer Ingelheim Investigational Site Greenbrae California
United States 1218.36.01004 Boehringer Ingelheim Investigational Site Greer South Carolina
United States 1218.36.01025 Boehringer Ingelheim Investigational Site Hickory North Carolina
United States 1218.36.01055 Boehringer Ingelheim Investigational Site Honolulu Hawaii
United States 1218.36.01016 Boehringer Ingelheim Investigational Site Houston Texas
United States 1218.36.01035 Boehringer Ingelheim Investigational Site Inverness Florida
United States 1218.36.01040 Boehringer Ingelheim Investigational Site Kansas City Missouri
United States 1218.36.01003 Boehringer Ingelheim Investigational Site Kingsport Tennessee
United States 1218.36.01024 Boehringer Ingelheim Investigational Site Lakewood Washington
United States 1218.36.01013 Boehringer Ingelheim Investigational Site Los Angeles California
United States 1218.36.01048 Boehringer Ingelheim Investigational Site Los Angeles California
United States 1218.36.01010 Boehringer Ingelheim Investigational Site Miami Florida
United States 1218.36.01053 Boehringer Ingelheim Investigational Site New Hartford New York
United States 1218.36.01042 Boehringer Ingelheim Investigational Site New Port Richey Florida
United States 1218.36.01012 Boehringer Ingelheim Investigational Site Norristown Pennsylvania
United States 1218.36.01018 Boehringer Ingelheim Investigational Site Omaha Nebraska
United States 1218.36.01011 Boehringer Ingelheim Investigational Site Paducah Kentucky
United States 1218.36.01063 Boehringer Ingelheim Investigational Site Pembroke Pines Florida
United States 1218.36.01037 Boehringer Ingelheim Investigational Site Ponte Vedra Florida
United States 1218.36.01007 Boehringer Ingelheim Investigational Site Renton Washington
United States 1218.36.01064 Boehringer Ingelheim Investigational Site Richmond Virginia
United States 1218.36.01009 Boehringer Ingelheim Investigational Site Roswell Georgia
United States 1218.36.01026 Boehringer Ingelheim Investigational Site Salt Lake city Utah
United States 1218.36.01058 Boehringer Ingelheim Investigational Site San Diego California
United States 1218.36.01008 Boehringer Ingelheim Investigational Site Santa Ana California
United States 1218.36.01020 Boehringer Ingelheim Investigational Site Simpsonville South Carolina
United States 1218.36.01027 Boehringer Ingelheim Investigational Site Spokane Washington
United States 1218.36.01032 Boehringer Ingelheim Investigational Site St. Cloud Florida
United States 1218.36.01029 Boehringer Ingelheim Investigational Site St. Louis Missouri
United States 1218.36.01034 Boehringer Ingelheim Investigational Site St. Peters Missouri
United States 1218.36.01049 Boehringer Ingelheim Investigational Site St. Petersburg Florida
United States 1218.36.01005 Boehringer Ingelheim Investigational Site Statesville North Carolina
United States 1218.36.01062 Boehringer Ingelheim Investigational Site Tacoma Washington
United States 1218.36.01039 Boehringer Ingelheim Investigational Site Tulsa Oklahoma
United States 1218.36.01056 Boehringer Ingelheim Investigational Site Waterbury Connecticut

Sponsors (2)
Lead Sponsor Collaborator
Boehringer Ingelheim Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  Czech Republic,  Finland,  Germany,  Greece,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  Norway,  Peru,  Russian Federation,  Slovakia,  Spain,  Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Other Number of Patients With HbA1c < 6.5 Percent 24 and 52 weeks No
Primary 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 No
Secondary Number of Patients With HbA1c < 7.0 Percent 24 and 52 weeks No
Secondary Number of Patients Lowering HbA1c by at Least 0.5 Percent 24 and 52 weeks No
Secondary Change From Baseline in HbA1c by Visit at Week 6 Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs Baseline and 6 weeks No
Secondary Change From Baseline in HbA1c by Visit at Week 12 Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs Baseline and 12 weeks No
Secondary Change From Baseline in HbA1c by Visit at Week 18 Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs Baseline and 18 weeks No
Secondary Change From Baseline in HbA1c by Visit at Week 32 Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs Baseline and 32 weeks No
Secondary Change From Baseline in HbA1c by Visit at Week 40 Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs Baseline and 40 weeks No
Secondary Change From Baseline in HbA1c by Visit at Week 52 Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs Baseline and 52 weeks No
Secondary Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment Means adjusted for treatment, baseline HbA1c, baseline FPG, categorical renal function impairment and concomitant OADs Baseline and 24 weeks No
Secondary Change From Baseline in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment Baseline and 52 weeks No
Secondary Change From Baseline in FPG Baseline, 6, 12, 18, 24, 32 and 40 weeks No
Secondary Change From Baseline in Mean Insulin Dose at 52 Weeks of Treatment Means adjusted for treatment, continous baseline HbA1c, continous baseline weight, continous baseline Insulin, categorical renal function impairment and concomitant OADs Baseline and 52 weeks No
Secondary Change From Baseline in Weighted Mean Daily Glucose After 24 and 52 Weeks of Treatment Mean Daily Glucose was calculated using the 8-point blood glucose profile Baseline, 24 and 52 weeks No
Secondary Change From Baseline in Incremental Post-prandial Glucose (iPPG) After 24 Weeks of Treatment Baseline and 24 weeks: post-breakfast, post-lunch, post-dinner No
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