Clinical trial NCT00621140: Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control
Official title: A Randomised, Double-blind, Placebo-controled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 24 Weeks, in Drug Naive or Previously Treated (6 Weeks Washout) Type 2 Diabetic Patients With Insufficient Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 503
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate efficacy, safety and tolerability of BI 1356 versus placebo


Eligibility criteria: Inclusion criteria:

* Male or female patients with type 2 diabetes and insufficient glycaemic control.
* Age 18 or over and not older than 80 years

Exclusion criteria:

* Use of more than one oral antidiabetic agent within 10 weeks prior to informed consent, insulin, glitazones or GLP-1 analogues within 3 months.
* Myocardial infarction, stroke or transient ischaemic attack within 6 months prior to informed consent.

Primary outcomes:
measure: HbA1c Change From Baseline at Week 24
timeFrame: Baseline and week 24
Secondary outcomes:
measure: HbA1c Change From Baseline at Week 6
timeFrame: Baseline and week 6
measure: HbA1c Change From Baseline at Week 12
timeFrame: Baseline and week 12
measure: HbA1c Change From Baseline at Week 18
timeFrame: Baseline and week 18
measure: FPG Change From Baseline at Week 24
timeFrame: Baseline and week 24
measure: FPG Change From Baseline at Week 6
timeFrame: Baseline and week 6
measure: FPG Change From Baseline at Week 12
timeFrame: Baseline and week 12
measure: FPG Change From Baseline at Week 18
timeFrame: Baseline and week 18
measure: Percentage of Patients With HbA1c <7.0% at Week 24
timeFrame: Baseline and week 24
measure: Percentage of Patients With HbA1c<7.0% at Week 24
timeFrame: Baseline and week 24
measure: Percentage of Patients With HbA1c <6.5% at Week 24
timeFrame: Baseline and week 24
measure: Percentage of Patients With HbA1c<6.5% at Week 24
timeFrame: Baseline and week 24
measure: Percentage of Patients With HbA1c Lowering by 0.5% at Week 24
timeFrame: Baseline and week 24
measure: Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24
timeFrame: Baseline and week 24
Other outcomes:
Locations:
city: Krapinske Toplice
country: Croatia
facility: 1218.16.38605 Boehringer Ingelheim Investigational Site
city: Slavonski Brod
country: Croatia
facility: 1218.16.38604 Boehringer Ingelheim Investigational Site
city: Andhra Pradesh
country: India
facility: 1218.16.91009 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1218.16.91002 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1218.16.91005 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 1218.16.91014 Boehringer Ingelheim Investigational Site
city: Ghaziabad
country: India
facility: 1218.16.91013 Boehringer Ingelheim Investigational Site
city: Hyderabad
country: India
facility: 1218.16.91010 Boehringer Ingelheim Investigational Site
city: Jaipur
country: India
facility: 1218.16.91006 Boehringer Ingelheim Investigational Site
city: Maharashtra
country: India
facility: 1218.16.91011 Boehringer Ingelheim Investigational Site
city: Mangalore
country: India
facility: 1218.16.91008 Boehringer Ingelheim Investigational Site
city: Manipal
country: India
facility: 1218.16.91007 Boehringer Ingelheim Investigational Site
city: Mumbai
country: India
facility: 1218.16.91004 Boehringer Ingelheim Investigational Site
city: Nasik
country: India
facility: 1218.16.91003 Boehringer Ingelheim Investigational Site
city: Tamilnadu
country: India
facility: 1218.16.91012 Boehringer Ingelheim Investigational Site
city: Trivandrum, Kerala
country: India
facility: 1218.16.91001 Boehringer Ingelheim Investigational Site
city: Givataim
country: Israel
facility: 1218.16.97267 Boehringer Ingelheim Investigational Site
city: Haifa
country: Israel
facility: 1218.16.97263 Boehringer Ingelheim Investigational Site
city: Holon
country: Israel
facility: 1218.16.97265 Boehringer Ingelheim Investigational Site
city: Jerusalem
country: Israel
facility: 1218.16.97261 Boehringer Ingelheim Investigational Site
city: Nahariya
country: Israel
facility: 1218.16.97262 Boehringer Ingelheim Investigational Site
city: Safed
country: Israel
facility: 1218.16.97266 Boehringer Ingelheim Investigational Site
city: Catanzaro
country: Italy
facility: 1218.16.39004 Boehringer Ingelheim Investigational Site
city: Genova
country: Italy
facility: 1218.16.39008 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1218.16.39002 Boehringer Ingelheim Investigational Site
city: Pisa
country: Italy
facility: 1218.16.39001 Boehringer Ingelheim Investigational Site
city: Roma
country: Italy
facility: 1218.16.39006 Boehringer Ingelheim Investigational Site
city: Alor Star
country: Malaysia
facility: 1218.16.60006 Boehringer Ingelheim Investigational Site
city: Kelantan Kota Bahru
country: Malaysia
facility: 1218.16.60003 Boehringer Ingelheim Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: 1218.16.60001 Boehringer Ingelheim Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: 1218.16.60002 Boehringer Ingelheim Investigational Site
city: Perak
country: Malaysia
facility: 1218.16.60004 Boehringer Ingelheim Investigational Site
city: Perak
country: Malaysia
facility: 1218.16.60005 Boehringer Ingelheim Investigational Site
city: Pulau Pinang
country: Malaysia
facility: 1218.16.60007 Boehringer Ingelheim Investigational Site
city: Andijk
country: Netherlands
facility: 1218.16.31009 Boehringer Ingelheim Investigational Site
city: Castricum
country: Netherlands
facility: 1218.16.31024 Boehringer Ingelheim Investigational Site
city: Deurne
country: Netherlands
facility: 1218.16.31006 Boehringer Ingelheim Investigational Site
city: Ewijk
country: Netherlands
facility: 1218.16.31001 Boehringer Ingelheim Investigational Site
city: Losser
country: Netherlands
facility: 1218.16.31010 Boehringer Ingelheim Investigational Site
city: Oude Pekela
country: Netherlands
facility: 1218.16.31003 Boehringer Ingelheim Investigational Site
city: Poortvliet
country: Netherlands
facility: 1218.16.31021 Boehringer Ingelheim Investigational Site
city: Rijswijk
country: Netherlands
facility: 1218.16.31004 Boehringer Ingelheim Investigational Site
city: Roelofarendsveen
country: Netherlands
facility: 1218.16.31008 Boehringer Ingelheim Investigational Site
city: Wildervank
country: Netherlands
facility: 1218.16.31002 Boehringer Ingelheim Investigational Site
city: Lublin
country: Poland
facility: 1218.16.48603 Boehringer Ingelheim Investigational Site
city: Warsaw
country: Poland
facility: 1218.16.48601 Boehringer Ingelheim Investigational Site
city: Zabrze
country: Poland
facility: 1218.16.48604 Boehringer Ingelheim Investigational Site
city: Brasov
country: Romania
facility: 1218.16.40604 Boehringer Ingelheim Investigational Site
city: Galati
country: Romania
facility: 1218.16.40603 Boehringer Ingelheim Investigational Site
city: Banska Bystrica
country: Slovakia
facility: 1218.16.42103 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 1218.16.42102 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 1218.16.42104 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 1218.16.42105 Boehringer Ingelheim Investigational Site
city: Nove Mesto nad Vahom
country: Slovakia
facility: 1218.16.42101 Boehringer Ingelheim Investigational Site
city: Samorin
country: Slovakia
facility: 1218.16.42106 Boehringer Ingelheim Investigational Site
city: Bangkok
country: Thailand
facility: 1218.16.66001 Boehringer Ingelheim Investigational Site
city: Khon Kaen
country: Thailand
facility: 1218.16.66002 Boehringer Ingelheim Investigational Site
city: Dnepropetrovsk
country: Ukraine
facility: 1218.16.38011 Boehringer Ingelheim Investigational Site
city: Kharkiv
country: Ukraine
facility: 1218.16.38002 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1218.16.38004 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1218.16.38010 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1218.16.38001 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1218.16.38005 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1218.16.38008 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1218.16.38009 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1218.16.38012 Boehringer Ingelheim Investigational Site
city: Lvov
country: Ukraine
facility: 1218.16.38003 Boehringer Ingelheim Investigational Site
city: Vinnitsa
country: Ukraine
facility: 1218.16.38006 Boehringer Ingelheim Investigational Site
city: Zaporizhzhya
country: Ukraine
facility: 1218.16.38007 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Del Prato S, Patel S, Crowe S, von Eynatten M. Efficacy and safety of linagliptin according to patient baseline characteristics: A pooled analysis of three phase 3 trials. Nutr Metab Cardiovasc Dis. 2016 Oct;26(10):886-92. doi: 10.1016/j.numecd.2016.06.015. Epub 2016 Jul 1.
citation: Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3.