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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00800683
First received: December 1, 2008
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: BI 1356
Drug: placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • HbA1c Change From Baseline at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • HbA1c Change From Baseline at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    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.

  • HbA1c Change From Baseline at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
    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.

  • HbA1c Change From Baseline at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    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.

  • HbA1c Change From Baseline at Week 30 [ Time Frame: Baseline and Week 30 ] [ Designated as safety issue: No ]
    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.

  • HbA1c Change From Baseline at Week 36 [ Time Frame: Baseline and Week 36 ] [ Designated as safety issue: No ]
    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.

  • HbA1c Change From Baseline at Week 42 [ Time Frame: Baseline and Week 42 ] [ Designated as safety issue: No ]
    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.

  • HbA1c Change From Baseline at Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
    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.

  • The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    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%

  • The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    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%.

  • Percentage of Patients With HbA1c Lowering by 0.5% at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    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).

  • FPG Change From Baseline at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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

  • FPG Change From Baseline at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
    Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs

  • FPG Change From Baseline at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    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

  • FPG Change From Baseline at Week 30 [ Time Frame: Baseline and Week 30 ] [ Designated as safety issue: No ]
    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

  • FPG Change From Baseline at Week 36 [ Time Frame: Baseline and Week 36 ] [ Designated as safety issue: No ]
    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

  • FPG Change From Baseline at Week 42 [ Time Frame: Baseline and Week 42 ] [ Designated as safety issue: No ]
    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

  • FPG Change From Baseline at Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
    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

  • FPG Change From Baseline at week52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    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

  • Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin.

  • Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG [ Time Frame: first administration of randomised treatment to .... ] [ Designated as safety issue: No ]
    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.


Enrollment: 133
Study Start Date: December 2008
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 1356
patient to receive a tablet containing BI 1356 once daily
Drug: BI 1356
BI 1356 dosed once daily
Placebo Comparator: placebo
patient to receive a tablet identical to BI 1356 once daily
Drug: placebo
placebo matching BI 1356 taken once daily

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800683

  Hide Study Locations
Locations
United States, Arizona
1218.43.10027 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
United States, California
1218.43.10011 Boehringer Ingelheim Investigational Site
Chula Vista, California, United States
1218.43.10006 Boehringer Ingelheim Investigational Site
Riverside, California, United States
1218.43.10021 Boehringer Ingelheim Investigational Site
Whittier, California, United States
United States, Florida
1218.43.10013 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States
1218.43.10009 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida, United States
United States, Georgia
1218.43.10018 Boehringer Ingelheim Investigational Site
Decatur, Georgia, United States
United States, Illinois
1218.43.10022 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
United States, Louisiana
1218.43.10015 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana, United States
United States, Missouri
1218.43.10016 Boehringer Ingelheim Investigational Site
Kansas City, Missouri, United States
United States, New York
1218.43.10004 Boehringer Ingelheim Investigational Site
Bronx, New York, United States
1218.43.10003 Boehringer Ingelheim Investigational Site
Great Neck, New York, United States
United States, North Carolina
1218.43.10020 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina, United States
United States, Ohio
1218.43.10019 Boehringer Ingelheim Investigational Site
Delaware, Ohio, United States
1218.43.10008 Boehringer Ingelheim Investigational Site
Mentor, Ohio, United States
United States, Pennsylvania
1218.43.10005 Boehringer Ingelheim Investigational Site
Bethlehem, Pennsylvania, United States
1218.43.10007 Boehringer Ingelheim Investigational Site
Carlisle, Pennsylvania, United States
United States, Rhode Island
1218.43.10001 Boehringer Ingelheim Investigational Site
Providence, Rhode Island, United States
United States, South Carolina
1218.43.10025 Boehringer Ingelheim Investigational Site
Aiken, South Carolina, United States
United States, Texas
1218.43.10024 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
1218.43.10023 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
1218.43.10014 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1218.43.10017 Boehringer Ingelheim Investigational Site
Lufkin, Texas, United States
United States, Washington
1218.43.10010 Boehringer Ingelheim Investigational Site
Tacoma, Washington, United States
Australia, New South Wales
1218.43.61009 Boehringer Ingelheim Investigational Site
Gosford, New South Wales, Australia
Australia, Queensland
1218.43.61010 Boehringer Ingelheim Investigational Site
Auchenflower, Queensland, Australia
1218.43.61006 Boehringer Ingelheim Investigational Site
Kippa Ring, Queensland, Australia
Australia, Victoria
1218.43.61007 Boehringer Ingelheim Investigational Site
Reservoir, Victoria, Australia
1218.43.61011 Boehringer Ingelheim Investigational Site
Richmond, Victoria, Australia
Australia
1218.43.61005 Boehringer Ingelheim Investigational Site
Adelaide, SA, Australia
1218.43.61002 Boehringer Ingelheim Investigational Site
Herston, QLD, Australia
Hong Kong
1218.43.85201 Boehringer Ingelheim Investigational Site
Hong Kong, Hong Kong
1218.43.85203 Boehringer Ingelheim Investigational Site
New Territories, Hong Kong
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
1218.43.97009 Boehringer Ingelheim Investigational Site
Jerusalem, Israel
1218.43.97004 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, Israel
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, New Zealand
Ukraine
1218.43.38004 Boehringer Ingelheim Investigational Site
Kharkiv, Ukraine
1218.43.38006 Boehringer Ingelheim Investigational Site
Kharkov, Ukraine
1218.43.38003 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, Ukraine
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00800683     History of Changes
Other Study ID Numbers: 1218.43, 2008-001569-27
Study First Received: December 1, 2008
Results First Received: December 30, 2011
Last Updated: May 15, 2014
Health Authority: Australia: Dept of Health and Ageing Therapeutic Goods Admin
Hong Kong: Department of Health
Israel: Ministry of Health
New Zealand: Medsafe
Ukraine: State Pharmacology Centre of the Ministry of Health of Ukraine
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Renal Insufficiency, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
BI 1356
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014