Clinical trial NCT00740051: A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate
Official title: A Randomised, db, Placebo-controlled, Parallel Group Efficacy and Safety Study of BI 1356 (5mg), Administered Orally Once Daily for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients With Insufficient Glycaemic Control for Whom Metformin Therapy is Inappropriate (Intolerability or Contraindication)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-08-22
Enrollment: 227
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: Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). The second part of the study looks at the safety of BI 1356 in this patient population with longer term treatment in comparison to a sulfonylurea drug (glimepiride)


Eligibility criteria: Inclusion criteria Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control (HbA1c 7% to 10%) for whom metformin therapy is inappropriate (intolerability or contraindication)

Exclusion criteria Myocardial infarction, stroke or Transient ischaemic attack in last 6 months Treatment with rosiglitazone or pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in past 3 months Impaired hepatic function Severe renal impairment current treatment with systemic steroids change in dosage of thyroid hormones hereditary galactose intolerance

Primary outcomes:
measure: HbA1c Change From Baseline at Week 18 (Interim Analysis)
timeFrame: Baseline and week 18
measure: HbA1c Change From Baseline at Week 18 (Final Analysis)
timeFrame: Baseline and week 18
Secondary outcomes:
measure: Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis)
timeFrame: Baseline and week 18
measure: Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis)
timeFrame: Week 18
measure: Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis)
timeFrame: Week 18
measure: Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis)
timeFrame: Week 18
measure: The Change in HbA1c From Baseline by Visit Over Time
timeFrame: Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52
measure: The Change in FPG From Baseline by Visit Over Time
timeFrame: Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 1218.50.10009 Boehringer Ingelheim Investigational Site
state: Alabama
city: Peoria
country: United States
facility: 1218.50.10011 Boehringer Ingelheim Investigational Site
state: Arizona
city: Greenbrae
country: United States
facility: 1218.50.10013 Boehringer Ingelheim Investigational Site
state: California
city: Harbor City
country: United States
facility: 1218.50.10016 Boehringer Ingelheim Investigational Site
state: California
city: Huntington Park
country: United States
facility: 1218.50.10017 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 1218.50.10006 Boehringer Ingelheim Investigational Site
state: California
city: Miami
country: United States
facility: 1218.50.10007 Boehringer Ingelheim Investigational Site
state: Florida
city: Statesville
country: United States
facility: 1218.50.10004 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Eugene
country: United States
facility: 1218.50.10002 Boehringer Ingelheim Investigational Site
state: Oregon
city: Greer
country: United States
facility: 1218.50.10015 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Kingsport
country: United States
facility: 1218.50.10005 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: 1218.50.10012 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 1218.50.10022 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1218.50.10010 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1218.50.10018 Boehringer Ingelheim Investigational Site
state: Texas
city: Edmonton
country: Canada
facility: 1218.50.11001 Boehringer Ingelheim Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: 1218.50.11003 Boehringer Ingelheim Investigational Site
state: Alberta
city: Sarnia
country: Canada
facility: 1218.50.11005 Boehringer Ingelheim Investigational Site
state: Ontario
city: Montague
country: Canada
facility: 1218.50.11002 Boehringer Ingelheim Investigational Site
state: Prince Edward Island
city: Saskatoon
country: Canada
facility: 1218.50.11004 Boehringer Ingelheim Investigational Site
state: Saskatchewan
city: Aguascalientes
country: Mexico
facility: 1218.50.52007 Boehringer Ingelheim Investigational Site
city: Guadalajara
country: Mexico
facility: 1218.50.52010 Boehringer Ingelheim Investigational Site
city: León
country: Mexico
facility: 1218.50.52009 Boehringer Ingelheim Investigational Site
city: Mexico
country: Mexico
facility: 1218.50.52002 Boehringer Ingelheim Investigational Site
city: Mexico
country: Mexico
facility: 1218.50.52008 Boehringer Ingelheim Investigational Site
city: Monterrey
country: Mexico
facility: 1218.50.52001 Boehringer Ingelheim Investigational Site
city: Monterrey
country: Mexico
facility: 1218.50.52003 Boehringer Ingelheim Investigational Site
city: México
country: Mexico
facility: 1218.50.52004 Boehringer Ingelheim Investigational Site
city: México
country: Mexico
facility: 1218.50.52005 Boehringer Ingelheim Investigational Site
city: Cebu
country: Philippines
facility: 1218.50.63003 Boehringer Ingelheim Investigational Site
city: Cebu
country: Philippines
facility: 1218.50.63005 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 1218.50.63006 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 1218.50.63008 Boehringer Ingelheim Investigational Site
city: Marikina
country: Philippines
facility: 1218.50.63001 Boehringer Ingelheim Investigational Site
city: Marikina
country: Philippines
facility: 1218.50.63004 Boehringer Ingelheim Investigational Site
city: Pasay
country: Philippines
facility: 1218.50.63007 Boehringer Ingelheim Investigational Site
city: Pasig
country: Philippines
facility: 1218.50.63002 Boehringer Ingelheim Investigational Site
city: Pasig
country: Philippines
facility: 1218.50.63009 Boehringer Ingelheim Investigational Site
city: Brasov
country: Romania
facility: 1218.50.40004 Boehringer Ingelheim Investigational Site
city: Bucharest
country: Romania
facility: 1218.50.40001 Boehringer Ingelheim Investigational Site
city: Bucharest
country: Romania
facility: 1218.50.40002 Boehringer Ingelheim Investigational Site
city: Galati
country: Romania
facility: 1218.50.40005 Boehringer Ingelheim Investigational Site
city: Sibiu
country: Romania
facility: 1218.50.40003 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1218.50.70001 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1218.50.70003 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1218.50.70002 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1218.50.70004 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1218.50.70005 Boehringer Ingelheim Investigational Site
city: Kharkiv
country: Ukraine
facility: 1218.50.38002 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1218.50.38001 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1218.50.38004 Boehringer Ingelheim Investigational Site
city: Lvov
country: Ukraine
facility: 1218.50.38003 Boehringer Ingelheim Investigational Site
city: Vinnitsa
country: Ukraine
facility: 1218.50.38005 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Barnett AH, Patel S, Harper R, Toorawa R, Thiemann S, von Eynatten M, Woerle HJ. Linagliptin monotherapy in type 2 diabetes patients for whom metformin is inappropriate: an 18-week randomized, double-blind, placebo-controlled phase III trial with a 34-week active-controlled extension. Diabetes Obes Metab. 2012 Dec;14(12):1145-54. doi: 10.1111/dom.12011. Epub 2012 Oct 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.