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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01194830
First received: September 2, 2010
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Linagliptin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase IIIb, 24-week, Randomised, Placebo-controlled, Double-blinded, Efficacy and Safety Study of Linagliptin (BI 1356) in Black/African American Patients With Type 2 Diabetes With a MTT Sub-study

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks [ Time Frame: baseline, 24 weeks ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin


Secondary Outcome Measures:
  • Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks [ Time Frame: baseline, 6 weeks ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  • Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  • Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks [ Time Frame: baseline, 18 weeks ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  • Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  • Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  • Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  • Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks [ Time Frame: baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in 2-hour Post-prandial Glucose (PPG) After 24 Weeks [ Time Frame: baseline, 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 234
Study Start Date: September 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Linagliptin
1 Tablet PO QD
Drug: Linagliptin
Active drug 1 tablet PO QD
Placebo Comparator: Placebo
1 Tablet PO QD
Drug: Placebo
1 Tablet PO QD

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Dated written informed consent that is in accordance with GCP and local legislation.
  2. Male and female Black / African American patients
  3. Diagnosis of type 2 diabetes at least 3 months prior to the informed consent.
  4. HbA1c more than or equal to 7.5% and less than or equal to 11% at Visit 1.
  5. 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.
  6. Age more than 18 and less than 80 years at Visit 1 (Screening).
  7. BMI (Body Mass Index) less than 45 kg/m2 at Visit 1.

Exclusion criteria:

  1. Myocardial infarction (MI), stroke or transient ischemic attack (TIA) within 3 months of informed consent.
  2. Type 1 diabetes.
  3. 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.
  4. Known prior hypersensitivity or allergy to the investigational product or its excipients.
  5. Treatment with insulin within 3 months prior to informed consent.
  6. Treatment with anti-obesity drugs (e.g., sibutramine, orlistat, rimonabant) within three months prior to informed consent or initiating therapy during the study.
  7. Any prior use of dipeptidyl peptidase-4 (DPP-4) inhibitors.
  8. Glucagon-like peptide-1 (GLP-1) agonists are excluded 3 months prior to informed consent.
  9. History of alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation as assessed by the Investigator.
  10. Participation in another trial with an investigational drug within 3 months prior to informed consent or during the study.
  11. 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.

  12. Current treatment with chronic use of systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
  13. History of bariatric surgery.
  14. Patients who have demonstrated an inability to be compliant (80-120%) with the dosing regimen during the placebo run-in period.
  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: NCT01194830

  Show 93 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01194830     History of Changes
Other Study ID Numbers: 1218.75
Study First Received: September 2, 2010
Results First Received: September 26, 2012
Last Updated: December 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System 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 23, 2014