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

NCT00800683 | Completed Phase 3 Results

• 2 other identifiers: 1218.432008-001569-27
• Study Type: interventional
• Target: 133
• Locations: 6 countries
• Sites: 53

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (20)

• HbA1c Change From Baseline at Week 52

  Baseline and Week 52

• HbA1c Change From Baseline at Week 18

  Baseline and Week 18

• HbA1c Change From Baseline at Week 24

  Baseline and Week 24

• HbA1c Change From Baseline at Week 30

  Baseline and Week 30

• HbA1c Change From Baseline at Week 36

  Baseline and Week 36

Study Arms (2)

BI 1356

EXPERIMENTAL

patient to receive a tablet containing BI 1356 once daily

Drug: BI 1356

placebo

PLACEBO COMPARATOR

patient to receive a tablet identical to BI 1356 once daily

Drug: placebo

Interventions

BI 1356 DRUG

BI 1356 dosed once daily

BI 1356

placebo DRUG

placebo matching BI 1356 taken once daily

placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (53)

1218.43.10027 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

1218.43.10011 Boehringer Ingelheim Investigational Site

Chula Vista, California, United States

Location

1218.43.10006 Boehringer Ingelheim Investigational Site

Riverside, California, United States

Location

1218.43.10021 Boehringer Ingelheim Investigational Site

Whittier, California, United States

Location

1218.43.10013 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Location

1218.43.10009 Boehringer Ingelheim Investigational Site

West Palm Beach, Florida, United States

Location

1218.43.10018 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

Location

1218.43.10022 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1218.43.10015 Boehringer Ingelheim Investigational Site

Shreveport, Louisiana, United States

Location

1218.43.10016 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Location

1218.43.10003 Boehringer Ingelheim Investigational Site

Great Neck, New York, United States

Location

1218.43.10004 Boehringer Ingelheim Investigational Site

The Bronx, New York, United States

Location

1218.43.10020 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

1218.43.10019 Boehringer Ingelheim Investigational Site

Delaware, Ohio, United States

Location

1218.43.10008 Boehringer Ingelheim Investigational Site

Mentor, Ohio, United States

Location

1218.43.10005 Boehringer Ingelheim Investigational Site

Bethlehem, Pennsylvania, United States

Location

1218.43.10007 Boehringer Ingelheim Investigational Site

Carlisle, Pennsylvania, United States

Location

1218.43.10001 Boehringer Ingelheim Investigational Site

Providence, Rhode Island, United States

Location

1218.43.10025 Boehringer Ingelheim Investigational Site

Aiken, South Carolina, United States

Location

1218.43.10023 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Location

1218.43.10024 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Location

1218.43.10014 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1218.43.10017 Boehringer Ingelheim Investigational Site

Lufkin, Texas, United States

Location

1218.43.10010 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Location

1218.43.61009 Boehringer Ingelheim Investigational Site

Gosford, New South Wales, Australia

Location

1218.43.61010 Boehringer Ingelheim Investigational Site

Auchenflower, Queensland, Australia

Location

1218.43.61006 Boehringer Ingelheim Investigational Site

Kippa-Ring, Queensland, Australia

Location

1218.43.61007 Boehringer Ingelheim Investigational Site

Reservoir, Victoria, Australia

Location

1218.43.61011 Boehringer Ingelheim Investigational Site

Richmond, Victoria, Australia

Location

1218.43.61005 Boehringer Ingelheim Investigational Site

Adelaide, SA, Australia

Location

1218.43.61002 Boehringer Ingelheim Investigational Site

Herston, QLD, Australia

Location

1218.43.85201 Boehringer Ingelheim Investigational Site

Hong Kong, Hong Kong

Location

1218.43.85203 Boehringer Ingelheim Investigational Site

New Territories, Hong Kong

Location

1218.43.97008 Boehringer Ingelheim Investigational Site

Afula, Israel

Location

1218.43.97005 Boehringer Ingelheim Investigational Site

Ashkelon, Israel

Location

1218.43.97003 Boehringer Ingelheim Investigational Site

Haifa, Israel

Location

1218.43.97004 Boehringer Ingelheim Investigational Site

Jerusalem, Israel

Location

1218.43.97009 Boehringer Ingelheim Investigational Site

Jerusalem, Israel

Location

1218.43.97002 Boehringer Ingelheim Investigational Site

Kfar Saba, Israel

Location

1218.43.97007 Boehringer Ingelheim Investigational Site

Nahariya, Israel

Location

1218.43.97001 Boehringer Ingelheim Investigational Site

Safed, Israel

Location

1218.43.97006 Boehringer Ingelheim Investigational Site

Tel Aviv, Israel

Location

1218.43.64001 Boehringer Ingelheim Investigational Site

Auckland, New Zealand

Location

1218.43.64003 Boehringer Ingelheim Investigational Site

Christchurch, New Zealand

Location

1218.43.64004 Boehringer Ingelheim Investigational Site

Takpuna, New Zealand

Location

1218.43.64002 Boehringer Ingelheim Investigational Site

Tauranga, New Zealand

Location

1218.43.38003 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1218.43.38004 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1218.43.38006 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1218.43.38005 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1218.43.38007 Boehringer Ingelheim Investigational Site

Luhansk, Ukraine

Location

1218.43.38008 Boehringer Ingelheim Investigational Site

Ternopil, Ukraine

Location

1218.43.38002 Boehringer Ingelheim Investigational Site

Zaporizhzhya, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 24169807 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Linagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2008
• First Posted: December 2, 2008
• Study Start: December 1, 2008
• Primary Completion: January 1, 2011
• Last Updated: May 20, 2014
• Results First Posted: February 1, 2012

Record last verified: 2014-05

Locations

US (24); AU (7); IL (9); NZ (4); UA (7); HK (2)