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NCT00798161 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A Phase III Randomised, Double-blind, Placebo-controlled Parallel Group Study to Compare the Efficacy and Safety of Twice Daily Administration of the Free Combination of BI 1356 2.5 mg + Metformin 500 mg, or of BI 1356 2.5 mg + Metformin 1000 mg, With the Individual Components of Metformin (500 mg or 1000 mg Twice Daily), and BI 1356 (5.0 mg Once Daily) Over 24 Weeks in Drug Naive or Previously Treated (4 Weeks Wash-out and 2 Weeks Placebo run-in) Type 2 Diabetic Patients With Insufficient Glycaemic Control

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00798161
Other study ID # 1218.46
Secondary ID 2008-001640-40
Status Completed
Phase Phase 3
First received November 24, 2008
Last updated December 11, 2013
Start date December 2008

Study information
Verified date December 2013
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada, Therapeutic Products DirectorateCroatia: Croatian Institute for Medicines Control, HR-10000 ZagrebEstonia: State Agency of Medicines, EE-5041TartuFrance: Agence Française de Sécurité Sanitaire des Produits de SantéGermany: BfArM-Federal Authorities for Drugs and Medical DevicesIndia: Drug Control General of IndiaLithuania: State Medicines Control Agency, LT-01132 VilniusMexico: Federal Commission for Sanitary Risks ProtectionNetherlands: Central Committee on Research Involving Human Subjects (CCMO)Romania: National Medicines Agency, BucharestRussia: Ministry of Healthcare and Social Development of Russian Federation, MoscowSweden: Medical Products Agency Regional Ethics Committee of UppsalaTunisia: Direction de la Pharmacie et du Médicament (DPM) 31, Rue de Khartoum 1002 Tunis - BelvédèreUkraine: Ministry of Health Care of Ukraine (MoH of Ukraine)
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 857
Est. completion date
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

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:
• BI 1356
BI 1356 high dose tablet, once daily
• BI 1356 + metformin
BI 1356 low dose tablet + Metformin 500 mg tablet, twice daily
• Bi 1356 + metformin
BI 1356 low dose tablet + Metformin 1000 mg tablet, twice daily
• Metformin
Metformin 500 mg tablet, twice daily
• metformin
metformin 1000 mg tablet, twice daily
• matching placebo
matching placebo

Locations
Country Name City State
Canada 1218.46.11005 Boehringer Ingelheim Investigational Site Calgary Alberta
Canada 1218.46.11003 Boehringer Ingelheim Investigational Site Edmonton Alberta
Canada 1218.46.11004 Boehringer Ingelheim Investigational Site Hamilton Ontario
Canada 1218.46.11007 Boehringer Ingelheim Investigational Site Oakville Ontario
Canada 1218.46.11009 Boehringer Ingelheim Investigational Site Oshawa Ontario
Canada 1218.46.11002 Boehringer Ingelheim Investigational Site Red Deer Alberta
Canada 1218.46.11010 Boehringer Ingelheim Investigational Site Toronto Ontario
Canada 1218.46.11006 Boehringer Ingelheim Investigational Site Vancouver British Columbia
Canada 1218.46.11008 Boehringer Ingelheim Investigational Site Winnipeg Manitoba
Croatia 1218.46.38502 Boehringer Ingelheim Investigational Site Karlovac
Croatia 1218.46.38503 Boehringer Ingelheim Investigational Site Krapinske Toplice
Croatia 1218.46.38504 Boehringer Ingelheim Investigational Site Osijek
Croatia 1218.46.38505 Boehringer Ingelheim Investigational Site Rijeka
Croatia 1218.46.38501 Boehringer Ingelheim Investigational Site Sisak
Croatia 1218.46.38506 Boehringer Ingelheim Investigational Site Zagreb
Estonia 1218.46.37202 Boehringer Ingelheim Investigational Site Pärnu
Estonia 1218.46.37201 Boehringer Ingelheim Investigational Site Tallin
Estonia 1218.46.37203 Boehringer Ingelheim Investigational Site Tallin
France 1218.46.3303D Boehringer Ingelheim Investigational Site Aire sur l'Aadour
France 1218.46.3308B Boehringer Ingelheim Investigational Site Bischheim
France 1218.46.3305A Boehringer Ingelheim Investigational Site Bourges
France 1218.46.3304F Boehringer Ingelheim Investigational Site Bousse
France 1218.46.3306D Boehringer Ingelheim Investigational Site Carresse Cassaber
France 1218.46.3308C Boehringer Ingelheim Investigational Site Gambsheim
France 1218.46.3305D Boehringer Ingelheim Investigational Site Garchizy
France 1218.46.3301A Boehringer Ingelheim Investigational Site Grenoble cédex
France 1218.46.3305B Boehringer Ingelheim Investigational Site Guerigny
France 1218.46.3304A Boehringer Ingelheim Investigational Site Jarny
France 1218.46.3302D Boehringer Ingelheim Investigational Site La Riche
France 1218.46.3307A Boehringer Ingelheim Investigational Site La Seyne sur Mer
France 1218.46.3307E Boehringer Ingelheim Investigational Site La Seyne sur Mer
France 1218.46.3305G Boehringer Ingelheim Investigational Site Lury
France 1218.46.3304D Boehringer Ingelheim Investigational Site Mars la Tour
France 1218.46.3304B Boehringer Ingelheim Investigational Site Mondelange
France 1218.46.3303A Boehringer Ingelheim Investigational Site Mont de Marsan
France 1218.46.3303C Boehringer Ingelheim Investigational Site Mont de Marsan
France 1218.46.3303E Boehringer Ingelheim Investigational Site Mont de Marsan
France 1218.46.3304C Boehringer Ingelheim Investigational Site Moutiers
France 1218.46.3308F Boehringer Ingelheim Investigational Site Mundolsheim
France 1218.46.3305C Boehringer Ingelheim Investigational Site Nevers
France 1218.46.3305E Boehringer Ingelheim Investigational Site Nevers
France 1218.46.3306A Boehringer Ingelheim Investigational Site Ortez
France 1218.46.3306C Boehringer Ingelheim Investigational Site Orthez
France 1218.46.3306E Boehringer Ingelheim Investigational Site Orthez
France 1218.46.3306F Boehringer Ingelheim Investigational Site Orthez
France 1218.46.3304E Boehringer Ingelheim Investigational Site Pont à Mousson
France 1218.46.3302B Boehringer Ingelheim Investigational Site Saint Avertin
France 1218.46.3302C Boehringer Ingelheim Investigational Site Saint Avertin
France 1218.46.3306B Boehringer Ingelheim Investigational Site Salies de Bearn
France 1218.46.3302E Boehringer Ingelheim Investigational Site Savonnières
France 1218.46.3303B Boehringer Ingelheim Investigational Site St Martin d'Oney
France 1218.46.3308A Boehringer Ingelheim Investigational Site Strasbourg
France 1218.46.3308D Boehringer Ingelheim Investigational Site Strasbourg
France 1218.46.3308E Boehringer Ingelheim Investigational Site Strasbourg
France 1218.46.3307B Boehringer Ingelheim Investigational Site Toulon
France 1218.46.3307C Boehringer Ingelheim Investigational Site Toulon
France 1218.46.3307D Boehringer Ingelheim Investigational Site Toulon
France 1218.46.3302A Boehringer Ingelheim Investigational Site Tours
France 1218.46.3304H Boehringer Ingelheim Investigational Site Vandoeuvre les Nancy
Germany 1218.46.49002 Boehringer Ingelheim Investigational Site Bad Dürrheim-Sunthausen
Germany 1218.46.49001 Boehringer Ingelheim Investigational Site Bad Mergentheim
Germany 1218.46.49006 Boehringer Ingelheim Investigational Site Köln
Germany 1218.46.49003 Boehringer Ingelheim Investigational Site München
Germany 1218.46.49008 Boehringer Ingelheim Investigational Site Neuwied
Germany 1218.46.49007 Boehringer Ingelheim Investigational Site Schauenburg
India 1218.46.91009 Boehringer Ingelheim Investigational Site Aurangabad
India 1218.46.91007 Boehringer Ingelheim Investigational Site Babgalore
India 1218.46.91001 Boehringer Ingelheim Investigational Site Bangalore
India 1218.46.91004 Boehringer Ingelheim Investigational Site Bangalore
India 1218.46.91012 Boehringer Ingelheim Investigational Site Bangalore
India 1218.46.91011 Boehringer Ingelheim Investigational Site Bhopal
India 1218.46.91003 Boehringer Ingelheim Investigational Site Chennai
India 1218.46.91020 Boehringer Ingelheim Investigational Site Chennai
India 1218.46.91018 Boehringer Ingelheim Investigational Site Hyderadad
India 1218.46.91008 Boehringer Ingelheim Investigational Site Jaipur
India 1218.46.91019 Boehringer Ingelheim Investigational Site Madurai
India 1218.46.91013 Boehringer Ingelheim Investigational Site Maharashtra
India 1218.46.91002 Boehringer Ingelheim Investigational Site Manipal
India 1218.46.91015 Boehringer Ingelheim Investigational Site Mumbai
India 1218.46.91014 Boehringer Ingelheim Investigational Site Nagpur
India 1218.46.91017 Boehringer Ingelheim Investigational Site New Delhi
India 1218.46.91016 Boehringer Ingelheim Investigational Site P.O Trivandrum
India 1218.46.91010 Boehringer Ingelheim Investigational Site Pune
India 1218.46.91006 Boehringer Ingelheim Investigational Site West Bengal
Lithuania 1218.46.37001 Boehringer Ingelheim Investigational Site Kaunas
Lithuania 1218.46.37004 Boehringer Ingelheim Investigational Site Kaunas
Lithuania 1218.46.37003 Boehringer Ingelheim Investigational Site Vilnius
Mexico 1218.46.52006 Boehringer Ingelheim Investigational Site Aguascalientes
Mexico 1218.46.52002 Boehringer Ingelheim Investigational Site Cuernavaca
Mexico 1218.46.52003 Boehringer Ingelheim Investigational Site Guadalajara
Mexico 1218.46.52004 Boehringer Ingelheim Investigational Site Guadalajara
Mexico 1218.46.52007 Boehringer Ingelheim Investigational Site Mexico
Mexico 1218.46.52008 Boehringer Ingelheim Investigational Site Mexico
Mexico 1218.46.52001 Boehringer Ingelheim Investigational Site Pachuca
Mexico 1218.46.52010 Boehringer Ingelheim Investigational Site Tijuana
Mexico 1218.46.52009 Boehringer Ingelheim Investigational Site Veracruz
Netherlands 1218.46.31004 Boehringer Ingelheim Investigational Site 's Hertogenbosch
Netherlands 1218.46.31005 Boehringer Ingelheim Investigational Site 's Hertogenbosch
Netherlands 1218.46.31001 Boehringer Ingelheim Investigational Site Almere
Netherlands 1218.46.31008 Boehringer Ingelheim Investigational Site Beek
Netherlands 1218.46.31002 Boehringer Ingelheim Investigational Site Beek en Donk
Netherlands 1218.46.31010 Boehringer Ingelheim Investigational Site Breda
Netherlands 1218.46.31011 Boehringer Ingelheim Investigational Site Eindhoven
Netherlands 1218.46.31013 Boehringer Ingelheim Investigational Site Groningen
Netherlands 1218.46.31012 Boehringer Ingelheim Investigational Site Leiderdrop
Netherlands 1218.46.31016 Boehringer Ingelheim Investigational Site Nijmegen
Netherlands 1218.46.31009 Boehringer Ingelheim Investigational Site Rotterdam
Netherlands 1218.46.31014 Boehringer Ingelheim Investigational Site Velp
Netherlands 1218.46.31015 Boehringer Ingelheim Investigational Site Zoetermeer
Romania 1218.46.40001 Boehringer Ingelheim Investigational Site Alba Iulia
Romania 1218.46.40005 Boehringer Ingelheim Investigational Site Galati
Romania 1218.46.40003 Boehringer Ingelheim Investigational Site Oradea
Romania 1218.46.40002 Boehringer Ingelheim Investigational Site Ploiesti
Romania 1218.46.40004 Boehringer Ingelheim Investigational Site Satu Mare
Russian Federation 1218.46.70001 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1218.46.70002 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1218.46.70003 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1218.46.70004 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1218.46.70006 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1218.46.70008 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1218.46.70005 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 1218.46.70007 Boehringer Ingelheim Investigational Site St. Petersburg
Sweden 1218.46.46002 Boehringer Ingelheim Investigational Site Goteborg
Sweden 1218.46.46004 Boehringer Ingelheim Investigational Site Goteborg
Sweden 1218.46.46003 Boehringer Ingelheim Investigational Site Malmo
Sweden 1218.46.46005 Boehringer Ingelheim Investigational Site Stockholm
Sweden 1218.46.46001 Boehringer Ingelheim Investigational Site Uppsala
Tunisia 1218.46.2162A Boehringer Ingelheim Investigational Site Bab Sâadoun Tunis
Tunisia 1218.46.2161A Boehringer Ingelheim Investigational Site Tunis
Tunisia 1218.46.2161B Boehringer Ingelheim Investigational Site Tunis
Tunisia 1218.46.2163A Boehringer Ingelheim Investigational Site Tunis
Tunisia 1218.46.2163B Boehringer Ingelheim Investigational Site Tunis
Ukraine 1218.46.38003 Boehringer Ingelheim Investigational Site Kiev
Ukraine 1218.46.38001 Boehringer Ingelheim Investigational Site Lviv
Ukraine 1218.46.38005 Boehringer Ingelheim Investigational Site Lvov
Ukraine 1218.46.38004 Boehringer Ingelheim Investigational Site Odesa
Ukraine 1218.46.38002 Boehringer Ingelheim Investigational Site Odessa
Ukraine 1218.46.38006 Boehringer Ingelheim Investigational Site Vinnitsa

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Canada,  Croatia,  Estonia,  France,  Germany,  India,  Lithuania,  Mexico,  Netherlands,  Romania,  Russian Federation,  Sweden,  Tunisia,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary HbA1c Change From Baseline at Week 6 HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. Baseline and week 6 No
Secondary HbA1c Change From Baseline at Week 12 HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. Baseline and week 12 No
Secondary HbA1c Change From Baseline at Week 18 HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. Baseline and week 18 No
Secondary FPG Change From Baseline at Week 24 This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication. Baseline and week 24 No
Secondary FPG Change From Baseline at Week 2 This change from baseline reflects the Week 2 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication. Baseline and week 2 No
Secondary FPG Change From Baseline at Week 6 This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication. Baseline and week 6 No
Secondary FPG Change From Baseline at Week 12 This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication. Baseline and week 12 No
Secondary FPG Change From Baseline at Week 18 This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication. Baseline and week 18 No
Secondary Percentage of Patients With HbA1c <7.0% at Week 24 The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. Baseline and Week 24 No
Secondary Percentage of Patients With HbA1c<7.0 at Week 24 The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. Baseline and Week 24 No
Secondary Percentage of Patients With HbA1c <6.5% at Week 24 The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c =< 6.5% Baseline and Week 24 No
Secondary Percentage of Patients With HbA1c < 6.5% at Week 24 The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5% Baseline and Week 24 No
Secondary Percentage of Patients With HbA1c Lowering by 0.5% at Week 24 The percentage of patients with an HbA1c reduction from baseline greater than 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%. Baseline and week 24 No
Secondary Adjusted Means for 2h Post-Prandial Glucose (PPG) Change From Baseline at Week 24 This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline 2h PPG and previous anti-diabetic medication. Baseline and week 24 No
Secondary HbA1c Change From Baseline at Week 24 for Open-label Patients HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percentage. Mean is unadjusted. Baseline and week 24 No
Secondary FPG Change From Baseline at Week 24 for Open-label Patients This change from baseline reflects the Week 24 FPG minus the baseline FPG. Mean is unadjusted. Baseline and week 24 No
Secondary Use of Rescue Therapy The use of rescue therapy (SUs, thiazolidinediones [TZDs], or insulin) was permitted only during the randomised treatment period of the trial (i.e. Visits 3 to 7), and was to be administered only if a patient had a 'confirmed' glucose level after an overnight fast. 24 weeks No
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