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NCT00819091 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00819091
Other study ID # 1218.35
Secondary ID 2008-003118-86
Status Completed
Phase Phase 3
First received January 7, 2009
Last updated June 17, 2014
Start date December 2008

Study information
Verified date December 2013
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Argentina: ANMAT (Food, Drug and Medical Technology National Administration)Hungary: National Institute of PharmacyIndia: Drugs Controller General IndiaJapan: Ministry of Health, Labor and WelfarePoland:Russia: Pharmacological Committee, Ministry of HealthUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 245
Est. completion date
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• BI 1356
5mg orally (po) tablet qd
• Placebo
Placebo matching BI 1356 5mg one tablet daily

Locations
Country Name City State
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
Hungary 1218.35.36001 Boehringer Ingelheim Investigational Site Budapest
Hungary 1218.35.36002 Boehringer Ingelheim Investigational Site Budapest
Hungary 1218.35.36004 Boehringer Ingelheim Investigational Site Budapest
Hungary 1218.35.36005 Boehringer Ingelheim Investigational Site Budapest
Hungary 1218.35.36003 Boehringer Ingelheim Investigational Site Debrecen
India 1218.35.91003 Boehringer Ingelheim Investigational Site Aligarh, Uttar Pradesh
India 1218.35.91007 Boehringer Ingelheim Investigational Site Aminjikarai, Tamilnadu
India 1218.35.91001 Boehringer Ingelheim Investigational Site Bangalore, Karnataka
India 1218.35.91004 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
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,
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
Russian Federation 1218.35.70008 Boehringer Ingelheim Investigational Site Arkhangelsk
Russian Federation 1218.35.70001 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 1218.35.70002 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 1218.35.70007 Boehringer Ingelheim Investigational Site Yaroslavl
United States 1218.35.10018 Boehringer Ingelheim Investigational Site Asheville North Carolina
United States 1218.35.10002 Boehringer Ingelheim Investigational Site Birmingham Alabama
United States 1218.35.10013 Boehringer Ingelheim Investigational Site Chicago Illinois
United States 1218.35.10004 Boehringer Ingelheim Investigational Site Cincinnati Ohio
United States 1218.35.10009 Boehringer Ingelheim Investigational Site Dallas Texas
United States 1218.35.10015 Boehringer Ingelheim Investigational Site Flint Michigan
United States 1218.35.10017 Boehringer Ingelheim Investigational Site Ft. Lauderdale Florida
United States 1218.35.10021 Boehringer Ingelheim Investigational Site Ft. Lauderdale Florida
United States 1218.35.10020 Boehringer Ingelheim Investigational Site Greenville South Carolina
United States 1218.35.10001 Boehringer Ingelheim Investigational Site Los Angeles California
United States 1218.35.10016 Boehringer Ingelheim Investigational Site National City California
United States 1218.35.10005 Boehringer Ingelheim Investigational Site Portland Oregon
United States 1218.35.10019 Boehringer Ingelheim Investigational Site Sugar Land Texas

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Argentina,  Hungary,  India,  Japan,  Poland,  Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18 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. Baseline, week 18 No
Secondary Change From Baseline in Fasting Plasma Glucose at Week 18 Change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication. Baseline, week 18 No
Secondary Percentage of Patients With Absolute Efficacy Response (HbA1c < 7%) at Week 18 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. week 18 No
Secondary Percentage of Patients With Absolute Efficacy Response (HbA1c < 6.5%) at Week 18 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. week 18 No
Secondary Percentage of Patients With HbA1c Lowering by at Least 0.5% From Baseline at Week 18 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. Baseline, week 18 No
Secondary Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 6 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. Baseline, week 6 No
Secondary Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 12 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. Baseline, week 12 No
Secondary Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 18 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. Baseline, week 18 No
Secondary Change From Baseline in Fasting Plasma Glucose at Week 6 Change from baseline reflects the Week 6 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication. Baseline, week 6 No
Secondary Change From Baseline in Fasting Plasma Glucose at Week 12 Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication. Baseline, week 12 No
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