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

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00621140

Purpose

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

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: linagliptin Drug: placebo	Phase III

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621140

Show 69 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

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:	August 23, 2011
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
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 February 21, 2012