Clinical trial NCT00800683: Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive
Official title: Safety in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 vs. Placebo, DB, Parallel Group, Randomized, Insulin Background Inclusive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-12-02
Enrollment: 133
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 determine safety, efficacy and tolerability of BI 1356 versus placebo


Eligibility criteria: Inclusion criteria:

* Male and female patients with type 2 diabetes and with glomerular filtration rate (GFR) \<30 ml/min, who are not on chronic dialysis.
* Insufficient glycemic control (hemoglobin A1c (HbA1c) between 7.0% and 10.0%)
* Age 18 or over and not older than 80 years

Exclusion criteria:

* Treatment with any other anti diabetic drug other than insulin and/or sulphonylurea within 3 months prior to informed consent
* Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
* Unstable or acute congestive heart failure

Primary outcomes:
measure: HbA1c Change From Baseline at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: HbA1c Change From Baseline at Week 52
timeFrame: Baseline and Week 52
measure: HbA1c Change From Baseline at Week 18
timeFrame: Baseline and Week 18
measure: HbA1c Change From Baseline at Week 24
timeFrame: Baseline and Week 24
measure: HbA1c Change From Baseline at Week 30
timeFrame: Baseline and Week 30
measure: HbA1c Change From Baseline at Week 36
timeFrame: Baseline and Week 36
measure: HbA1c Change From Baseline at Week 42
timeFrame: Baseline and Week 42
measure: HbA1c Change From Baseline at Week 48
timeFrame: Baseline and Week 48
measure: The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment
timeFrame: Baseline and Week 52
measure: The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment
timeFrame: Baseline and Week 52
measure: Percentage of Patients With HbA1c Lowering by 0.5% at Week 52
timeFrame: Baseline and Week 52
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: FPG Change From Baseline at Week 24
timeFrame: Baseline and Week 24
measure: FPG Change From Baseline at Week 30
timeFrame: Baseline and Week 30
measure: FPG Change From Baseline at Week 36
timeFrame: Baseline and Week 36
measure: FPG Change From Baseline at Week 42
timeFrame: Baseline and Week 42
measure: FPG Change From Baseline at Week 48
timeFrame: Baseline and Week 48
measure: FPG Change From Baseline at week52
timeFrame: Baseline and Week 52
measure: Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time
timeFrame: Baseline and Week 52
measure: Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
timeFrame: first administration of randomised treatment to ....
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: 1218.43.10027 Boehringer Ingelheim Investigational Site
state: Arizona
city: Chula Vista
country: United States
facility: 1218.43.10011 Boehringer Ingelheim Investigational Site
state: California
city: Riverside
country: United States
facility: 1218.43.10006 Boehringer Ingelheim Investigational Site
state: California
city: Whittier
country: United States
facility: 1218.43.10021 Boehringer Ingelheim Investigational Site
state: California
city: Pembroke Pines
country: United States
facility: 1218.43.10013 Boehringer Ingelheim Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: 1218.43.10009 Boehringer Ingelheim Investigational Site
state: Florida
city: Decatur
country: United States
facility: 1218.43.10018 Boehringer Ingelheim Investigational Site
state: Georgia
city: Chicago
country: United States
facility: 1218.43.10022 Boehringer Ingelheim Investigational Site
state: Illinois
city: Shreveport
country: United States
facility: 1218.43.10015 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Kansas City
country: United States
facility: 1218.43.10016 Boehringer Ingelheim Investigational Site
state: Missouri
city: Bronx
country: United States
facility: 1218.43.10004 Boehringer Ingelheim Investigational Site
state: New York
city: Great Neck
country: United States
facility: 1218.43.10003 Boehringer Ingelheim Investigational Site
state: New York
city: Winston-Salem
country: United States
facility: 1218.43.10020 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Delaware
country: United States
facility: 1218.43.10019 Boehringer Ingelheim Investigational Site
state: Ohio
city: Mentor
country: United States
facility: 1218.43.10008 Boehringer Ingelheim Investigational Site
state: Ohio
city: Bethlehem
country: United States
facility: 1218.43.10005 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Carlisle
country: United States
facility: 1218.43.10007 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: 1218.43.10001 Boehringer Ingelheim Investigational Site
state: Rhode Island
city: Aiken
country: United States
facility: 1218.43.10025 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Austin
country: United States
facility: 1218.43.10023 Boehringer Ingelheim Investigational Site
state: Texas
city: Austin
country: United States
facility: 1218.43.10024 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 1218.43.10014 Boehringer Ingelheim Investigational Site
state: Texas
city: Lufkin
country: United States
facility: 1218.43.10017 Boehringer Ingelheim Investigational Site
state: Texas
city: Tacoma
country: United States
facility: 1218.43.10010 Boehringer Ingelheim Investigational Site
state: Washington
city: Gosford
country: Australia
facility: 1218.43.61009 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Auchenflower
country: Australia
facility: 1218.43.61010 Boehringer Ingelheim Investigational Site
state: Queensland
city: Kippa Ring
country: Australia
facility: 1218.43.61006 Boehringer Ingelheim Investigational Site
state: Queensland
city: Reservoir
country: Australia
facility: 1218.43.61007 Boehringer Ingelheim Investigational Site
state: Victoria
city: Richmond
country: Australia
facility: 1218.43.61011 Boehringer Ingelheim Investigational Site
state: Victoria
city: Adelaide, SA
country: Australia
facility: 1218.43.61005 Boehringer Ingelheim Investigational Site
city: Herston, QLD
country: Australia
facility: 1218.43.61002 Boehringer Ingelheim Investigational Site
city: Hong Kong
country: Hong Kong
facility: 1218.43.85201 Boehringer Ingelheim Investigational Site
city: New Territories
country: Hong Kong
facility: 1218.43.85203 Boehringer Ingelheim Investigational Site
city: Afula
country: Israel
facility: 1218.43.97008 Boehringer Ingelheim Investigational Site
city: Ashkelon
country: Israel
facility: 1218.43.97005 Boehringer Ingelheim Investigational Site
city: Haifa
country: Israel
facility: 1218.43.97003 Boehringer Ingelheim Investigational Site
city: Jerusalem
country: Israel
facility: 1218.43.97004 Boehringer Ingelheim Investigational Site
city: Jerusalem
country: Israel
facility: 1218.43.97009 Boehringer Ingelheim Investigational Site
city: Kfar Saba
country: Israel
facility: 1218.43.97002 Boehringer Ingelheim Investigational Site
city: Nahariya
country: Israel
facility: 1218.43.97007 Boehringer Ingelheim Investigational Site
city: Safed
country: Israel
facility: 1218.43.97001 Boehringer Ingelheim Investigational Site
city: Tel Aviv
country: Israel
facility: 1218.43.97006 Boehringer Ingelheim Investigational Site
city: Auckland
country: New Zealand
facility: 1218.43.64001 Boehringer Ingelheim Investigational Site
city: Christchurch
country: New Zealand
facility: 1218.43.64003 Boehringer Ingelheim Investigational Site
city: Takpuna
country: New Zealand
facility: 1218.43.64004 Boehringer Ingelheim Investigational Site
city: Tauranga
country: New Zealand
facility: 1218.43.64002 Boehringer Ingelheim Investigational Site
city: Kharkiv
country: Ukraine
facility: 1218.43.38004 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1218.43.38003 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1218.43.38006 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1218.43.38005 Boehringer Ingelheim Investigational Site
city: Lugansk
country: Ukraine
facility: 1218.43.38007 Boehringer Ingelheim Investigational Site
city: Ternopil
country: Ukraine
facility: 1218.43.38008 Boehringer Ingelheim Investigational Site
city: Zaporizhzhya
country: Ukraine
facility: 1218.43.38002 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.