Randomized, Double-blind (db), Placebo-controlled 18 Week Study of Linagliptin (BI 1356) in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00819091
First received: January 7, 2009
Last updated: May 18, 2012
Last verified: May 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: BI 1356 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 Randomized, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 18 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control (HbA1c 7.0-10%) Despite Background Therapy With a Sulfonylurea Drug. |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18 [ Time Frame: Baseline, week 18 ] [ Designated as safety issue: No ]HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.
Secondary Outcome Measures:
- Change From Baseline in Fasting Plasma Glucose at Week 18 [ Time Frame: Baseline, week 18 ] [ Designated as safety issue: No ]Change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.
- Percentage of Patients With Absolute Efficacy Response (HbA1c < 7%) at Week 18 [ Time Frame: week 18 ] [ Designated as safety issue: No ]An absolute efficacy response is defined as HbA1c < 7.0% at 18 weeks. A non-response is defined as HbA1c >= 7.0% at 18 weeks.
- Percentage of Patients With Absolute Efficacy Response (HbA1c < 6.5%) at Week 18 [ Time Frame: week 18 ] [ Designated as safety issue: No ]An absolute efficacy response is defined as HbA1c < 6.5% at 18 weeks. A non-response is defined as HbA1c >= 6.5% at 18 weeks.
- Percentage of Patients With HbA1c Lowering by at Least 0.5% From Baseline at Week 18 [ Time Frame: Baseline, week 18 ] [ Designated as safety issue: No ]An efficacy response is defined as HbA1c lowered by 0.5% or more at 18 weeks. A non-response is defined as HbA1c not lowered by 0.5% or more at 18 weeks.
- Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 6 [ Time Frame: Baseline, week 6 ] [ Designated as safety issue: No ]HbA1c is measured as a percent. The change from baseline reflects the Week 6 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.
- Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 12 [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]HbA1c is measured as a percent. The change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.
- Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 18 [ Time Frame: Baseline, week 18 ] [ Designated as safety issue: No ]HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.
- Change From Baseline in Fasting Plasma Glucose at Week 6 [ Time Frame: Baseline, week 6 ] [ Designated as safety issue: No ]Change from baseline reflects the Week 6 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.
- Change From Baseline in Fasting Plasma Glucose at Week 12 [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.
| Enrollment: | 245 |
| Study Start Date: | December 2008 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: BI 1356
5 mg orally (po) once daily
|
Drug: BI 1356
5mg orally (po) tablet qd
|
|
Placebo Comparator: Placebo
one tablet once daily
|
Drug: Placebo
Placebo matching BI 1356 5mg one tablet daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control [glycosylated hemoglobin (HbA1c 7% to 10%)] despite therapy with a sulfonylurea drug
Exclusion criteria:
Myocardial infarction,stroke or transient ischaemic attack in last 6 months Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in the past 3 months Impaired hepatic function Severe renal impairment Current treatment with systemic steroids Change in thyroid hormone dosage Hereditary galactose intolerance
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819091
Hide Study Locations
Hide Study LocationsLocations
| United States, Alabama | |
| 1218.35.10002 Boehringer Ingelheim Investigational Site | |
| Birmingham, Alabama, United States | |
| United States, California | |
| 1218.35.10001 Boehringer Ingelheim Investigational Site | |
| Los Angeles, California, United States | |
| 1218.35.10016 Boehringer Ingelheim Investigational Site | |
| National City, California, United States | |
| United States, Florida | |
| 1218.35.10021 Boehringer Ingelheim Investigational Site | |
| Ft. Lauderdale, Florida, United States | |
| 1218.35.10017 Boehringer Ingelheim Investigational Site | |
| Ft. Lauderdale, Florida, United States | |
| United States, Illinois | |
| 1218.35.10013 Boehringer Ingelheim Investigational Site | |
| Chicago, Illinois, United States | |
| United States, Michigan | |
| 1218.35.10015 Boehringer Ingelheim Investigational Site | |
| Flint, Michigan, United States | |
| United States, North Carolina | |
| 1218.35.10018 Boehringer Ingelheim Investigational Site | |
| Asheville, North Carolina, United States | |
| United States, Ohio | |
| 1218.35.10004 Boehringer Ingelheim Investigational Site | |
| Cincinnati, Ohio, United States | |
| United States, Oregon | |
| 1218.35.10005 Boehringer Ingelheim Investigational Site | |
| Portland, Oregon, United States | |
| United States, South Carolina | |
| 1218.35.10020 Boehringer Ingelheim Investigational Site | |
| Greenville, South Carolina, United States | |
| United States, Texas | |
| 1218.35.10009 Boehringer Ingelheim Investigational Site | |
| Dallas, Texas, United States | |
| 1218.35.10019 Boehringer Ingelheim Investigational Site | |
| Sugar Land, Texas, United States | |
| Argentina | |
| 1218.35.54003 Boehringer Ingelheim Investigational Site | |
| Capital Federal, Argentina | |
| 1218.35.54005 Boehringer Ingelheim Investigational Site | |
| Corrientes, Argentina | |
| 1218.35.54001 Boehringer Ingelheim Investigational Site | |
| Mar del Plata, Argentina | |
| 1218.35.54006 Boehringer Ingelheim Investigational Site | |
| Parque Velez Sarfield, Argentina | |
| Hungary | |
| 1218.35.36005 Boehringer Ingelheim Investigational Site | |
| Budapest, Hungary | |
| 1218.35.36004 Boehringer Ingelheim Investigational Site | |
| Budapest, Hungary | |
| 1218.35.36001 Boehringer Ingelheim Investigational Site | |
| Budapest, Hungary | |
| 1218.35.36002 Boehringer Ingelheim Investigational Site | |
| Budapest, Hungary | |
| 1218.35.36003 Boehringer Ingelheim Investigational Site | |
| Debrecen, Hungary | |
| India | |
| 1218.35.91003 Boehringer Ingelheim Investigational Site | |
| Aligarh, Uttar Pradesh, India | |
| 1218.35.91007 Boehringer Ingelheim Investigational Site | |
| Aminjikarai, Tamilnadu, India | |
| 1218.35.91004 Boehringer Ingelheim Investigational Site | |
| Bangalore, Karnataka, India | |
| 1218.35.91001 Boehringer Ingelheim Investigational Site | |
| Bangalore, Karnataka, India | |
| 1218.35.91002 Boehringer Ingelheim Investigational Site | |
| Indore, India | |
| 1218.35.91008 Boehringer Ingelheim Investigational Site | |
| Mumbai, Maharastra, India | |
| 1218.35.91005 Boehringer Ingelheim Investigational Site | |
| Nagpur, Maharashtra, India | |
| 1218.35.91006 Boehringer Ingelheim Investigational Site | |
| Pune, Maharastra, India | |
| Japan | |
| 1218.35.81003 Boehringer Ingelheim Investigational Site | |
| Osaka, Osaka, Japan | |
| 1218.35.81001 Boehringer Ingelheim Investigational Site | |
| Shinjyuku-ku,Tokyo, Japan | |
| 1218.35.81002 Boehringer Ingelheim Investigational Site | |
| Suita, Osaka,, Japan | |
| Poland | |
| 1218.35.48002 Boehringer Ingelheim Investigational Site | |
| Bialystok, Poland | |
| 1218.35.48004 Boehringer Ingelheim Investigational Site | |
| Lublin, Poland | |
| 1218.35.48003 Boehringer Ingelheim Investigational Site | |
| Poznan, Poland | |
| 1218.35.48001 Boehringer Ingelheim Investigational Site | |
| Rzeszow, Poland | |
| 1218.35.48005 Boehringer Ingelheim Investigational Site | |
| Wroclaw, Poland | |
| Russian Federation | |
| 1218.35.70008 Boehringer Ingelheim Investigational Site | |
| Arkhangelsk, Russian Federation | |
| 1218.35.70001 Boehringer Ingelheim Investigational Site | |
| St. Petersburg, Russian Federation | |
| 1218.35.70003 Boehringer Ingelheim Investigational Site | |
| St. Petersburg, Russian Federation | |
| 1218.35.70006 Boehringer Ingelheim Investigational Site | |
| St. Petersburg, Russian Federation | |
| 1218.35.70009 Boehringer Ingelheim Investigational Site | |
| St. Petersburg, Russian Federation | |
| 1218.35.70002 Boehringer Ingelheim Investigational Site | |
| St. Petersburg, Russian Federation | |
| 1218.35.70007 Boehringer Ingelheim Investigational Site | |
| Yaroslavl, Russian Federation | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided by Boehringer Ingelheim Pharmaceuticals
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00819091 History of Changes |
| Other Study ID Numbers: | 1218.35, 2008-003118-86 |
| Study First Received: | January 7, 2009 |
| Results First Received: | May 13, 2011 |
| Last Updated: | May 18, 2012 |
| Health Authority: | Argentina: ANMAT (Food, Drug and Medical Technology National Administration) Hungary: National Institute of Pharmacy India: Drugs Controller General India Japan: Ministry of Health, Labor and Welfare Poland: Russia: Pharmacological Committee, Ministry of Health 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 May 19, 2013