Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00621140
First received: January 14, 2008
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

To investigate efficacy, safety and tolerability of BI 1356 versus placebo


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 Randomised, Double-blind, Placebo-controled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 24 Weeks, in Drug Naive or Previously Treated (6 Weeks Washout) Type 2 Diabetic Patients With Insufficient Glycemic Control

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • HbA1c Change From Baseline at Week 24 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]
    HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.


Secondary Outcome Measures:
  • HbA1c Change From Baseline at Week 6 [ Time Frame: Baseline and week 6 ] [ Designated as safety issue: No ]
    HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

  • HbA1c Change From Baseline at Week 12 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
    HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c 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 percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

  • 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 baseline HbA1c, baseline FPG and previous anti-diabetic medication.

  • FPG Change From Baseline at Week 6 [ Time Frame: Baseline and week 6 ] [ Designated as safety issue: No ]
    This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.

  • 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 baseline HbA1c, baseline FPG and previous anti-diabetic medication.

  • FPG Change From Baseline at Week 18 [ Time Frame: Baseline and week 18 ] [ Designated as safety issue: No ]
    This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.

  • Percentage of Patients With HbA1c <7.0% at Week 24 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]
    The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%. Only patients with baseline HbA1c >= 7%

  • Percentage of Patients With HbA1c<7.0% at Week 24 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]
    The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%.

  • Percentage of Patients With HbA1c <6.5% at Week 24 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]
    The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%. Only patients with baseline HbA1c >= 6.5%.

  • Percentage of Patients With HbA1c<6.5% at Week 24 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]
    The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%.

  • Percentage of Patients With HbA1c Lowering by 0.5% at Week 24 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]
    The percentage of patients with an HbA1c reduction from baseline >= 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.

  • Adjusted Means for 2h Post Prandial Blood Glucose (PPG) 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 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline PPG and previous anti-diabetic medication.


Enrollment: 503
Study Start Date: February 2008
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: linagliptin 5 mg
linagliptin 5 mg once daily
Drug: linagliptin
active
Placebo Comparator: placebo
placebo matching linagliptin 5 mg tablets
Drug: placebo
placebo

  Eligibility

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

Inclusion criteria:

  • Male or female patients with type 2 diabetes and insufficient glycaemic control.
  • Age 18 or over and not older than 80 years

Exclusion criteria:

  • Use of more than one oral antidiabetic agent within 10 weeks prior to informed consent, insulin, glitazones or GLP-1 analogues within 3 months.
  • Myocardial infarction, stroke or transient ischaemic attack within 6 months prior to informed consent.
  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: NCT00621140

  Show 69 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
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, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00621140     History of Changes
Other Study ID Numbers: 1218.16, 2007-002448-10
Study First Received: January 14, 2008
Results First Received: May 13, 2011
Last Updated: January 22, 2014
Health Authority: Croatia: Croatian Institute for Medicines Control, HR-10000 Zagreb
India: Drug Control General of India
Israel: No regulatory agency approval needed for clinical trials
Italy: Comitato Etico per la sperim. clinica dei medicinali dell'A.O. Universitaria Pisana di Pisa
Malaysia: Ministry of Health, Malaysia
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Urzad Rejestracji Produktow Leczniczych, Wyrobow, Medycznych i Produktow Biobojczych, PL-00725 Warsaw
Romania: National Medicines Agency, Bucharest
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26
Thailand: Ministry of Public Health
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014