Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800683
• Other study ID #: 1218.43
• Secondary ID: 2008-001569-27
• Status: Completed
• Phase: Phase 3
• First received: December 1, 2008
• Last updated: May 15, 2014
• Start date: December 2008

Study information

• Verified date: May 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Dept of Health and Ageing Therapeutic Goods AdminHong Kong: Department of HealthIsrael: Ministry of HealthNew Zealand: MedsafeUkraine: State Pharmacology Centre of the Ministry of Health of UkraineUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

to determine safety, efficacy and tolerability of BI 1356 versus placebo

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• BI 1356
BI 1356 dosed once daily
• placebo
placebo matching BI 1356 taken once daily

Locations

Country	Name	City	State
Australia	1218.43.61005 Boehringer Ingelheim Investigational Site	Adelaide, SA
Australia	1218.43.61010 Boehringer Ingelheim Investigational Site	Auchenflower	Queensland
Australia	1218.43.61009 Boehringer Ingelheim Investigational Site	Gosford	New South Wales
Australia	1218.43.61002 Boehringer Ingelheim Investigational Site	Herston, QLD
Australia	1218.43.61006 Boehringer Ingelheim Investigational Site	Kippa Ring	Queensland
Australia	1218.43.61007 Boehringer Ingelheim Investigational Site	Reservoir	Victoria
Australia	1218.43.61011 Boehringer Ingelheim Investigational Site	Richmond	Victoria
Hong Kong	1218.43.85201 Boehringer Ingelheim Investigational Site	Hong Kong
Hong Kong	1218.43.85203 Boehringer Ingelheim Investigational Site	New Territories
Israel	1218.43.97008 Boehringer Ingelheim Investigational Site	Afula
Israel	1218.43.97005 Boehringer Ingelheim Investigational Site	Ashkelon
Israel	1218.43.97003 Boehringer Ingelheim Investigational Site	Haifa
Israel	1218.43.97004 Boehringer Ingelheim Investigational Site	Jerusalem
Israel	1218.43.97009 Boehringer Ingelheim Investigational Site	Jerusalem
Israel	1218.43.97002 Boehringer Ingelheim Investigational Site	Kfar Saba
Israel	1218.43.97007 Boehringer Ingelheim Investigational Site	Nahariya
Israel	1218.43.97001 Boehringer Ingelheim Investigational Site	Safed
Israel	1218.43.97006 Boehringer Ingelheim Investigational Site	Tel Aviv
New Zealand	1218.43.64001 Boehringer Ingelheim Investigational Site	Auckland
New Zealand	1218.43.64003 Boehringer Ingelheim Investigational Site	Christchurch
New Zealand	1218.43.64004 Boehringer Ingelheim Investigational Site	Takpuna
New Zealand	1218.43.64002 Boehringer Ingelheim Investigational Site	Tauranga
Ukraine	1218.43.38004 Boehringer Ingelheim Investigational Site	Kharkiv
Ukraine	1218.43.38003 Boehringer Ingelheim Investigational Site	Kharkov
Ukraine	1218.43.38006 Boehringer Ingelheim Investigational Site	Kharkov
Ukraine	1218.43.38005 Boehringer Ingelheim Investigational Site	Kiev
Ukraine	1218.43.38007 Boehringer Ingelheim Investigational Site	Lugansk
Ukraine	1218.43.38008 Boehringer Ingelheim Investigational Site	Ternopil
Ukraine	1218.43.38002 Boehringer Ingelheim Investigational Site	Zaporizhzhya
United States	1218.43.10025 Boehringer Ingelheim Investigational Site	Aiken	South Carolina
United States	1218.43.10023 Boehringer Ingelheim Investigational Site	Austin	Texas
United States	1218.43.10024 Boehringer Ingelheim Investigational Site	Austin	Texas
United States	1218.43.10005 Boehringer Ingelheim Investigational Site	Bethlehem	Pennsylvania
United States	1218.43.10004 Boehringer Ingelheim Investigational Site	Bronx	New York
United States	1218.43.10007 Boehringer Ingelheim Investigational Site	Carlisle	Pennsylvania
United States	1218.43.10022 Boehringer Ingelheim Investigational Site	Chicago	Illinois
United States	1218.43.10011 Boehringer Ingelheim Investigational Site	Chula Vista	California
United States	1218.43.10014 Boehringer Ingelheim Investigational Site	Dallas	Texas
United States	1218.43.10018 Boehringer Ingelheim Investigational Site	Decatur	Georgia
United States	1218.43.10019 Boehringer Ingelheim Investigational Site	Delaware	Ohio
United States	1218.43.10003 Boehringer Ingelheim Investigational Site	Great Neck	New York
United States	1218.43.10016 Boehringer Ingelheim Investigational Site	Kansas City	Missouri
United States	1218.43.10017 Boehringer Ingelheim Investigational Site	Lufkin	Texas
United States	1218.43.10008 Boehringer Ingelheim Investigational Site	Mentor	Ohio
United States	1218.43.10013 Boehringer Ingelheim Investigational Site	Pembroke Pines	Florida
United States	1218.43.10027 Boehringer Ingelheim Investigational Site	Phoenix	Arizona
United States	1218.43.10001 Boehringer Ingelheim Investigational Site	Providence	Rhode Island
United States	1218.43.10006 Boehringer Ingelheim Investigational Site	Riverside	California
United States	1218.43.10015 Boehringer Ingelheim Investigational Site	Shreveport	Louisiana
United States	1218.43.10010 Boehringer Ingelheim Investigational Site	Tacoma	Washington
United States	1218.43.10009 Boehringer Ingelheim Investigational Site	West Palm Beach	Florida
United States	1218.43.10021 Boehringer Ingelheim Investigational Site	Whittier	California
United States	1218.43.10020 Boehringer Ingelheim Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Hong Kong,  Israel,  New Zealand,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c Change From Baseline at Week 12	HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline continuous HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.	Baseline and Week 12	No
Secondary	HbA1c Change From Baseline at Week 52	HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.	Baseline and Week 52	No
Secondary	HbA1c Change From Baseline at Week 18	HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.	Baseline and Week 18	No
Secondary	HbA1c Change From Baseline at Week 24	HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.	Baseline and Week 24	No
Secondary	HbA1c Change From Baseline at Week 30	HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.	Baseline and Week 30	No
Secondary	HbA1c Change From Baseline at Week 36	HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 36 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.	Baseline and Week 36	No
Secondary	HbA1c Change From Baseline at Week 42	HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 42 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.	Baseline and Week 42	No
Secondary	HbA1c Change From Baseline at Week 48	HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 48 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.	Baseline and Week 48	No
Secondary	The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment	The percentage of patients with an HbA1c value below 6.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=6.5%	Baseline and Week 52	No
Secondary	The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment	The percentage of patients with an HbA1c value below 7.0% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=7%.	Baseline and Week 52	No
Secondary	Percentage of Patients With HbA1c Lowering by 0.5% at Week 52	The percentage of patients with an HbA1c reduction from baseline >=0.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF).	Baseline and Week 52	No
Secondary	FPG Change From Baseline at Week 12	This change from baseline reflects the week 12 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs	Baseline and Week 12	No
Secondary	FPG Change From Baseline at Week 18	Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs	Baseline and Week 18	No
Secondary	FPG Change From Baseline at Week 24	This change from baseline reflects the week 24 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs	Baseline and Week 24	No
Secondary	FPG Change From Baseline at Week 30	This change from baseline reflects the week 30 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs	Baseline and Week 30	No
Secondary	FPG Change From Baseline at Week 36	This change from baseline reflects the week 36 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs	Baseline and Week 36	No
Secondary	FPG Change From Baseline at Week 42	This change from baseline reflects the week 42 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs	Baseline and Week 42	No
Secondary	FPG Change From Baseline at Week 48	This change from baseline reflects the week 48 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs	Baseline and Week 48	No
Secondary	FPG Change From Baseline at week52	This change from baseline reflects the week 52 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs	Baseline and Week 52	No
Secondary	Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time	Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin.	Baseline and Week 52	No
Secondary	Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG	Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.	first administration of randomised treatment to ....	No

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