Clinical trial NCT00819091: Randomized, Double-blind (db), Placebo-controlled 18 Week Study of Linagliptin (BI 1356) in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug
Official title: A Randomized, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 18 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control (HbA1c 7.0-10%) Despite Background Therapy With a Sulfonylurea Drug.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-01-08
Enrollment: 245
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 and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.


Eligibility criteria: Inclusion criteria:

Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control \[glycosylated hemoglobin (HbA1c 7% to 10%)\] despite therapy with a sulfonylurea drug

Exclusion criteria:

Myocardial infarction,stroke or transient ischaemic attack in last 6 months Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in the past 3 months Impaired hepatic function Severe renal impairment Current treatment with systemic steroids Change in thyroid hormone dosage Hereditary galactose intolerance

Primary outcomes:
measure: Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18
timeFrame: Baseline, week 18
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose at Week 18
timeFrame: Baseline, week 18
measure: Percentage of Patients With Absolute Efficacy Response (HbA1c < 7%) at Week 18
timeFrame: week 18
measure: Percentage of Patients With Absolute Efficacy Response (HbA1c < 6.5%) at Week 18
timeFrame: week 18
measure: Percentage of Patients With HbA1c Lowering by at Least 0.5% From Baseline at Week 18
timeFrame: Baseline, week 18
measure: Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 6
timeFrame: Baseline, week 6
measure: Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 12
timeFrame: Baseline, week 12
measure: Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 18
timeFrame: Baseline, week 18
measure: Change From Baseline in Fasting Plasma Glucose at Week 6
timeFrame: Baseline, week 6
measure: Change From Baseline in Fasting Plasma Glucose at Week 12
timeFrame: Baseline, week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 1218.35.10002 Boehringer Ingelheim Investigational Site
state: Alabama
city: Los Angeles
country: United States
facility: 1218.35.10001 Boehringer Ingelheim Investigational Site
state: California
city: National City
country: United States
facility: 1218.35.10016 Boehringer Ingelheim Investigational Site
state: California
city: Ft. Lauderdale
country: United States
facility: 1218.35.10017 Boehringer Ingelheim Investigational Site
state: Florida
city: Ft. Lauderdale
country: United States
facility: 1218.35.10021 Boehringer Ingelheim Investigational Site
state: Florida
city: Chicago
country: United States
facility: 1218.35.10013 Boehringer Ingelheim Investigational Site
state: Illinois
city: Flint
country: United States
facility: 1218.35.10015 Boehringer Ingelheim Investigational Site
state: Michigan
city: Asheville
country: United States
facility: 1218.35.10018 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: 1218.35.10004 Boehringer Ingelheim Investigational Site
state: Ohio
city: Portland
country: United States
facility: 1218.35.10005 Boehringer Ingelheim Investigational Site
state: Oregon
city: Greenville
country: United States
facility: 1218.35.10020 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: 1218.35.10009 Boehringer Ingelheim Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: 1218.35.10019 Boehringer Ingelheim Investigational Site
state: Texas
city: Capital Federal
country: Argentina
facility: 1218.35.54003 Boehringer Ingelheim Investigational Site
city: Corrientes
country: Argentina
facility: 1218.35.54005 Boehringer Ingelheim Investigational Site
city: Mar del Plata
country: Argentina
facility: 1218.35.54001 Boehringer Ingelheim Investigational Site
city: Parque Velez Sarfield
country: Argentina
facility: 1218.35.54006 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1218.35.36001 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1218.35.36002 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1218.35.36004 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1218.35.36005 Boehringer Ingelheim Investigational Site
city: Debrecen
country: Hungary
facility: 1218.35.36003 Boehringer Ingelheim Investigational Site
city: Aligarh, Uttar Pradesh
country: India
facility: 1218.35.91003 Boehringer Ingelheim Investigational Site
city: Aminjikarai, Tamilnadu
country: India
facility: 1218.35.91007 Boehringer Ingelheim Investigational Site
city: Bangalore, Karnataka
country: India
facility: 1218.35.91001 Boehringer Ingelheim Investigational Site
city: Bangalore, Karnataka
country: India
facility: 1218.35.91004 Boehringer Ingelheim Investigational Site
city: Indore
country: India
facility: 1218.35.91002 Boehringer Ingelheim Investigational Site
city: Mumbai, Maharastra
country: India
facility: 1218.35.91008 Boehringer Ingelheim Investigational Site
city: Nagpur, Maharashtra
country: India
facility: 1218.35.91005 Boehringer Ingelheim Investigational Site
city: Pune, Maharastra
country: India
facility: 1218.35.91006 Boehringer Ingelheim Investigational Site
city: Osaka, Osaka
country: Japan
facility: 1218.35.81003 Boehringer Ingelheim Investigational Site
city: Shinjyuku-ku,Tokyo
country: Japan
facility: 1218.35.81001 Boehringer Ingelheim Investigational Site
city: Suita, Osaka,
country: Japan
facility: 1218.35.81002 Boehringer Ingelheim Investigational Site
city: Bialystok
country: Poland
facility: 1218.35.48002 Boehringer Ingelheim Investigational Site
city: Lublin
country: Poland
facility: 1218.35.48004 Boehringer Ingelheim Investigational Site
city: Poznan
country: Poland
facility: 1218.35.48003 Boehringer Ingelheim Investigational Site
city: Rzeszow
country: Poland
facility: 1218.35.48001 Boehringer Ingelheim Investigational Site
city: Wroclaw
country: Poland
facility: 1218.35.48005 Boehringer Ingelheim Investigational Site
city: Arkhangelsk
country: Russian Federation
facility: 1218.35.70008 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1218.35.70001 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1218.35.70002 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1218.35.70003 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1218.35.70006 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1218.35.70009 Boehringer Ingelheim Investigational Site
city: Yaroslavl
country: Russian Federation
facility: 1218.35.70007 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: McGill JB, Barnett AH, Lewin AJ, Patel S, Neubacher D, von Eynatten M, Woerle HJ. Linagliptin added to sulphonylurea in uncontrolled type 2 diabetes patients with moderate-to-severe renal impairment. Diab Vasc Dis Res. 2014 Jan;11(1):34-40. doi: 10.1177/1479164113507068. Epub 2013 Oct 29.
citation: Lewin AJ, Arvay L, Liu D, Patel S, von Eynatten M, Woerle HJ. Efficacy and tolerability of linagliptin added to a sulfonylurea regimen in patients with inadequately controlled type 2 diabetes mellitus: an 18-week, multicenter, randomized, double-blind, placebo-controlled trial. Clin Ther. 2012 Sep;34(9):1909-19.e15. doi: 10.1016/j.clinthera.2012.07.008. Epub 2012 Aug 29.
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.