Efficacy and Safety of Linagliptin (BI 1356) in Black/African Americans With Type 2 Diabetes With a MTT Sub-study

NCT01194830 | Completed Phase 3 Results

• 1 other identifier: 1218.75
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 93

Brief Summary

Study of linagliptin vs. placebo in Black/African American patients with T2DM with a MTT sub-study

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks

  Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  baseline, 24 weeks

Secondary Outcomes (8)

• Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks

  baseline, 6 weeks

• Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks

  baseline, 12 weeks

• Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks

  baseline, 18 weeks

• Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks

  24 weeks

• Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks

  24 weeks

Study Arms (2)

Linagliptin

ACTIVE COMPARATOR

1 Tablet PO QD

Drug: Linagliptin

Placebo

PLACEBO COMPARATOR

1 Tablet PO QD

Drug: Placebo

Interventions

Linagliptin DRUG

Active drug 1 tablet PO QD

Linagliptin

Placebo DRUG

1 Tablet PO QD

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:

• Dated written informed consent that is in accordance with GCP and local legislation.
• Male and female Black / African American patients
• Diagnosis of type 2 diabetes at least 3 months prior to the informed consent.
• HbA1c more than or equal to 7.5% and less than or equal to 11% at Visit 1.
• Patients are currently treatment-naive or being treated with up to one oral antidiabetic medication. Antidiabetic medication is to be unchanged for at least 10 weeks prior to the informed consent.
• Age more than 18 and less than 80 years at Visit 1 (Screening).
• BMI (Body Mass Index) less than 45 kg/m2 at Visit 1.

You may not qualify if:

• Myocardial infarction (MI), stroke or transient ischemic attack (TIA) within 3 months of informed consent.
• Type 1 diabetes.
• Impaired hepatic function, defined by serum levels of either alanine aminotransferase (ALT, SGPT), aspartate aminotransferase (AST, SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1.
• Known prior hypersensitivity or allergy to the investigational product or its excipients.
• Treatment with insulin within 3 months prior to informed consent.
• Treatment with anti-obesity drugs (e.g., sibutramine, orlistat, rimonabant) within three months prior to informed consent or initiating therapy during the study.
• Any prior use of dipeptidyl peptidase-4 (DPP-4) inhibitors.
• Glucagon-like peptide-1 (GLP-1) agonists are excluded 3 months prior to informed consent.
• History of alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation as assessed by the Investigator.
• Participation in another trial with an investigational drug within 3 months prior to informed consent or during the study.
• Pre-menopausal women (last menstruation less than 1 year prior to informed consent) who:
• are nursing or pregnant
• are not surgically sterile
• or are of child-bearing potential and are not practicing an acceptable method of birth control or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intrauterine devices/systems (IUDs / IUSs), oral, implantable or injectable contraceptives, and vasectomised partners. No exceptions will be made.
• Hormonal birth control should have been in use for at least three months prior to signing informed consent and continue at least until the next menstrual period after completing the study.

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Eli Lilly and Company: collaborator

Study Sites (93)

1218.75.059 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

1218.75.054 Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

Location

1218.75.035 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Location

1218.75.101 Boehringer Ingelheim Investigational Site

Toney, Alabama, United States

Location

1218.75.066 Boehringer Ingelheim Investigational Site

Little Rock, Alaska, United States

Location

1218.75.008 Boehringer Ingelheim Investigational Site

Pell City, Alaska, United States

Location

1218.75.071 Boehringer Ingelheim Investigational Site

Anaheim, California, United States

Location

1218.75.018 Boehringer Ingelheim Investigational Site

Chino, California, United States

Location

1218.75.081 Boehringer Ingelheim Investigational Site

Garden Grove, California, United States

Location

1218.75.109 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1218.75.040 Boehringer Ingelheim Investigational Site

Colorado Springs, Colorado, United States

Location

1218.75.047 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

1218.75.106 Boehringer Ingelheim Investigational Site

Bartow, Florida, United States

Location

1218.75.098 Boehringer Ingelheim Investigational Site

Bradenton, Florida, United States

Location

1218.75.036 Boehringer Ingelheim Investigational Site

Chiefland, Florida, United States

Location

1218.75.105 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Location

1218.75.083 Boehringer Ingelheim Investigational Site

Fort Myers, Florida, United States

Location

1218.75.002 Boehringer Ingelheim Investigational Site

Hialeah, Florida, United States

Location

1218.75.080 Boehringer Ingelheim Investigational Site

Jacksonville, Florida, United States

Location

1218.75.065 Boehringer Ingelheim Investigational Site

Jupiter, Florida, United States

Location

1218.75.007 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1218.75.029 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1218.75.045 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1218.75.084 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1218.75.017 Boehringer Ingelheim Investigational Site

Ocala, Florida, United States

Location

1218.75.012 Boehringer Ingelheim Investigational Site

Pinellas Park, Florida, United States

Location

1218.75.074 Boehringer Ingelheim Investigational Site

Port Orange, Florida, United States

Location

1218.75.076 Boehringer Ingelheim Investigational Site

South Miami, Florida, United States

Location

1218.75.003 Boehringer Ingelheim Investigational Site

St. Petersburg, Florida, United States

Location

1218.75.039 Boehringer Ingelheim Investigational Site

St. Petersburg, Florida, United States

Location

1218.75.075 Boehringer Ingelheim Investigational Site

Tallahassee, Florida, United States

Location

1218.75.100 Boehringer Ingelheim Investigational Site

Tamarac, Florida, United States

Location

1218.75.015 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

1218.75.103 Boehringer Ingelheim Investigational Site

West Palm Beach, Florida, United States

Location

1218.75.049 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

1218.75.067 Boehringer Ingelheim Investigational Site

Calhoun, Georgia, United States

Location

1218.75.016 Boehringer Ingelheim Investigational Site

Dunwoody, Georgia, United States

Location

1218.75.063 Boehringer Ingelheim Investigational Site

Lawrenceville, Georgia, United States

Location

1218.75.056 Boehringer Ingelheim Investigational Site

Marietta, Georgia, United States

Location

1218.75.026 Boehringer Ingelheim Investigational Site

Rosswell, Georgia, United States

Location

1218.75.079 Boehringer Ingelheim Investigational Site

Sandy Springs, Georgia, United States

Location

1218.75.034 Boehringer Ingelheim Investigational Site

Snellville, Georgia, United States

Location

1218.75.001 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1218.75.055 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1218.75.069 Boehringer Ingelheim Investigational Site

Owensboro, Kentucky, United States

Location

1218.75.044 Boehringer Ingelheim Investigational Site

Baton Rouge, Louisiana, United States

Location

1218.75.108 Boehringer Ingelheim Investigational Site

Essex, Maryland, United States

Location

1218.75.086 Boehringer Ingelheim Investigational Site

Brockton, Massachusetts, United States

Location

1218.75.087 Boehringer Ingelheim Investigational Site

Watertown, Massachusetts, United States

Location

1218.75.051 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

Location

1218.75.088 Boehringer Ingelheim Investigational Site

Flint, Michigan, United States

Location

1218.75.099 Boehringer Ingelheim Investigational Site

Biloxi, Mississippi, United States

Location

1218.75.006 Boehringer Ingelheim Investigational Site

Atco, New Jersey, United States

Location

1218.75.004 Boehringer Ingelheim Investigational Site

Camden, New Jersey, United States

Location

1218.75.031 Boehringer Ingelheim Investigational Site

Brooklyn, New York, United States

Location

1218.75.095 Boehringer Ingelheim Investigational Site

Brooklyn, New York, United States

Location

1218.75.038 Boehringer Ingelheim Investigational Site

Asheboro, North Carolina, United States

Location

1218.75.009 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Location

1218.75.023 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Location

1218.75.060 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Location

1218.75.005 Boehringer Ingelheim Investigational Site

Greensboro, North Carolina, United States

Location

1218.75.107 Boehringer Ingelheim Investigational Site

High Point, North Carolina, United States

Location

1218.75.020 Boehringer Ingelheim Investigational Site

Jacksonville, North Carolina, United States

Location

1218.75.027 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

1218.75.096 Boehringer Ingelheim Investigational Site

Akron, Ohio, United States

Location

1218.75.090 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

1218.75.078 Boehringer Ingelheim Investigational Site

Dayton, Ohio, United States

Location

1218.75.037 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1218.75.082 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1218.75.010 Boehringer Ingelheim Investigational Site

Uniontown, Pennsylvania, United States

Location

1218.75.028 Boehringer Ingelheim Investigational Site

Uniontown, Pennsylvania, United States

Location

1218.75.091 Boehringer Ingelheim Investigational Site

Anderson, South Carolina, United States

Location

1218.75.072 Boehringer Ingelheim Investigational Site

Columbia, South Carolina, United States

Location

1218.75.068 Boehringer Ingelheim Investigational Site

Greenwood, South Carolina, United States

Location

1218.75.097 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

Location

1218.75.024 Boehringer Ingelheim Investigational Site

Brentwood, Tennessee, United States

Location

1218.75.025 Boehringer Ingelheim Investigational Site

Collierville, Tennessee, United States

Location

1218.75.011 Boehringer Ingelheim Investigational Site

Germantown, Tennessee, United States

Location

1218.75.042 Boehringer Ingelheim Investigational Site

Humboldt, Tennessee, United States

Location

1218.75.030 Boehringer Ingelheim Investigational Site

Memphis, Tennessee, United States

Location

1218.75.050 Boehringer Ingelheim Investigational Site

Memphis, Tennessee, United States

Location

1218.75.053 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1218.75.057 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1218.75.064 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1218.75.104 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1218.75.043 Boehringer Ingelheim Investigational Site

Houton, Texas, United States

Location

1218.75.022 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1218.75.058 Boehringer Ingelheim Investigational Site

Sugar Land, Texas, United States

Location

1218.75.033 Boehringer Ingelheim Investigational Site

Tomball, Texas, United States

Location

1218.75.102 Boehringer Ingelheim Investigational Site

Tomball, Texas, United States

Location

1218.75.094 Boehringer Ingelheim Investigational Site

Waco, Texas, United States

Location

1218.75.092 Boehringer Ingelheim Investigational Site

Whitney, Texas, United States

Location

1218.75.019 Boehringer Ingelheim Investigational Site

Virgnia Beach, Virginia, United States

Location

Related Publications (2)

• Lajara R, Aguilar R, Hehnke U, Woerle HJ, von Eynatten M. Efficacy and safety of linagliptin in subjects with long-standing type 2 diabetes mellitus (>10 years): evidence from pooled data of randomized, double-blind, placebo-controlled, phase III trials. Clin Ther. 2014 Nov 1;36(11):1595-605. doi: 10.1016/j.clinthera.2014.07.020. Epub 2014 Sep 16.

  PMID: 25236917 DERIVED

• Thrasher J, Daniels K, Patel S, Whetteckey J. Black/African American patients with type 2 diabetes mellitus: study design and baseline patient characteristics from a randomized clinical trial of linagliptin. Expert Opin Pharmacother. 2012 Dec;13(17):2443-52. doi: 10.1517/14656566.2012.740459. Epub 2012 Nov 8.

  PMID: 23134211 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

Limitations and Caveats

Eight randomized subjects were excluded from all analysis due to overall data integrity issues at the site

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: September 2, 2010
• First Posted: September 3, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 29, 2014
• Results First Posted: October 26, 2012

Record last verified: 2013-12

Locations

US (93)