Clinical trial NCT01087502: Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment
Official title: A Phase III, Randomised, Double-blind, Placebo-controlled Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 12 Weeks Followed by a 40 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Drug Naive or Previously Treated Type 2 Diabetic Patients With Moderate to Severe Renal Impairment and Insufficient Glycaemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2010-03-16
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or previously treated type 2 diabetic patients with moderate to severe renal impairment and insufficient glycaemic control. In addition safety in this patient population with longer term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).


Eligibility criteria: Inclusion criteria:

1. Type 2 diabetes mellitus
2. GFR\<60 ml/min
3. HbA1c \>=7.0% to \<= 10%
4. Age \>= 18 years
5. BMI \<=45 kg/m2
6. Signed and dated written informed consent

Exclusion criteria:

1. Myocardial infarction, stroke or TIA within 3 months prior to informed consent
2. Renal impairment requiring dialysis
3. Bariatric surgery
4. Impaired hepatic function
5. Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors
6. Treatment with anti-obesity drugs
7. Treatment with SU, glinides and metformin 8 weeks prior to informed consent

Primary outcomes:
measure: HbA1c Change From Baseline to Week 12
timeFrame: Baseline and week 12
Secondary outcomes:
measure: HbA1c Change From Baseline Over Time
timeFrame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 34, week 40, week 46, week 52
measure: Fasting Plasma Glucose (FPG) Change From Baseline to Week 12
timeFrame: Baseline and week 12
measure: Fasting Plasma Glucose (FPG) Change From Baseline Over Time
timeFrame: Baseline, week 4, week 8, week 12, week 20, week 24, week 28, week 34, week 40, week 46, week 52
measure: Percentage of Patients With HbA1c <7.0%
timeFrame: Baseline, week 12 and week 52
measure: Percentage of Patients With HbA1c <6.5%
timeFrame: Baseline, week 12 and week 52
measure: Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5%
timeFrame: Baseline, week 12 and week 52
measure: Plasma Concentration of Linagliptin at Trough
timeFrame: Week 12, 24 and 52
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: 1218.64.10007 Boehringer Ingelheim Investigational Site
state: California
city: Pembroke Pines
country: United States
facility: 1218.64.10018 Boehringer Ingelheim Investigational Site
state: Florida
city: Decatur
country: United States
facility: 1218.64.10016 Boehringer Ingelheim Investigational Site
state: Georgia
city: Boise
country: United States
facility: 1218.64.10015 Boehringer Ingelheim Investigational Site
state: Idaho
city: Chicago
country: United States
facility: 1218.64.10002 Boehringer Ingelheim Investigational Site
state: Illinois
city: Flint
country: United States
facility: 1218.64.10004 Boehringer Ingelheim Investigational Site
state: Michigan
city: Kansas City
country: United States
facility: 1218.64.10006 Boehringer Ingelheim Investigational Site
state: Missouri
city: Bronx
country: United States
facility: 1218.64.10003 Boehringer Ingelheim Investigational Site
state: New York
city: Philadelphia
country: United States
facility: 1218.64.10013 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: 1218.64.10020 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 1218.64.10008 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Arlington
country: United States
facility: 1218.64.10009 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 1218.64.10005 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1218.64.10011 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1218.64.10014 Boehringer Ingelheim Investigational Site
state: Texas
city: Tacoma
country: United States
facility: 1218.64.10010 Boehringer Ingelheim Investigational Site
state: Washington
city: Gosford
country: Australia
facility: 1218.64.61005 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Liverpool
country: Australia
facility: 1218.64.61001 Boehringer Ingelheim Investigational Site
state: New South Wales
city: St Leonards
country: Australia
facility: 1218.64.61002 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Adelaide
country: Australia
facility: 1218.64.61003 Boehringer Ingelheim Investigational Site
state: South Australia
city: Reservoir
country: Australia
facility: 1218.64.61004 Boehringer Ingelheim Investigational Site
state: Victoria
city: Corunna
country: Canada
facility: 1218.64.20008 Boehringer Ingelheim Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: 1218.64.20005 Boehringer Ingelheim Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: 1218.64.20007 Boehringer Ingelheim Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: 1218.64.20002 Boehringer Ingelheim Investigational Site
state: Ontario
city: Stayner
country: Canada
facility: 1218.64.20009 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1218.64.20004 Boehringer Ingelheim Investigational Site
state: Ontario
city: Point Claire
country: Canada
facility: 1218.64.20003 Boehringer Ingelheim Investigational Site
state: Quebec
city: Kokkola
country: Finland
facility: 1218.64.35804 Boehringer Ingelheim Investigational Site
city: Oulu
country: Finland
facility: 1218.64.35803 Boehringer Ingelheim Investigational Site
city: Turku
country: Finland
facility: 1218.64.35801 Boehringer Ingelheim Investigational Site
city: Ashkelon
country: Israel
facility: 1218.64.97204 Boehringer Ingelheim Investigational Site
city: Givatayim
country: Israel
facility: 1218.64.97207 Boehringer Ingelheim Investigational Site
city: Haifa
country: Israel
facility: 1218.64.97203 Boehringer Ingelheim Investigational Site
city: Jerusalem
country: Israel
facility: 1218.64.97201 Boehringer Ingelheim Investigational Site
city: Nahariya
country: Israel
facility: 1218.64.97202 Boehringer Ingelheim Investigational Site
city: Tel Aviv
country: Israel
facility: 1218.64.97206 Boehringer Ingelheim Investigational Site
city: Asahi, Chiba
country: Japan
facility: 1218.64.81005 Boehringer Ingelheim Investigational Site
city: Isesaki, Gunma
country: Japan
facility: 1218.64.81006 Boehringer Ingelheim Investigational Site
city: Meguro-ku, Tokyo
country: Japan
facility: 1218.64.81001 Boehringer Ingelheim Investigational Site
city: Nagoya, Aichi
country: Japan
facility: 1218.64.81008 Boehringer Ingelheim Investigational Site
city: Osaka, Osaka
country: Japan
facility: 1218.64.81007 Boehringer Ingelheim Investigational Site
city: Shinjyuku-ku,Tokyo
country: Japan
facility: 1218.64.81002 Boehringer Ingelheim Investigational Site
city: Suita, Osaka
country: Japan
facility: 1218.64.81004 Boehringer Ingelheim Investigational Site
city: Suwa, Nagano
country: Japan
facility: 1218.64.81003 Boehringer Ingelheim Investigational Site
city: Otahuhu Auckland
country: New Zealand
facility: 1218.64.64001 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 1218.64.42102 Boehringer Ingelheim Investigational Site
city: Kosice
country: Slovakia
facility: 1218.64.42107 Boehringer Ingelheim Investigational Site
city: Nitra
country: Slovakia
facility: 1218.64.42109 Boehringer Ingelheim Investigational Site
city: Trencin
country: Slovakia
facility: 1218.64.42108 Boehringer Ingelheim Investigational Site
city: Helsingborg
country: Sweden
facility: 1218.64.46003 Boehringer Ingelheim Investigational Site
city: Härnösand
country: Sweden
facility: 1218.64.46002 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: