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NCT00621140 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00621140
Other study ID # 1218.16
Secondary ID 2007-002448-10
Status Completed
Phase Phase 3
First received January 14, 2008
Last updated January 22, 2014
Start date February 2008

Study information
Verified date January 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Croatia: Croatian Institute for Medicines Control, HR-10000 ZagrebIndia: Drug Control General of IndiaIsrael: No regulatory agency approval needed for clinical trialsItaly: Comitato Etico per la sperim. clinica dei medicinali dell'A.O. Universitaria Pisana di PisaMalaysia: Ministry of Health, MalaysiaNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Poland: Urzad Rejestracji Produktow Leczniczych, Wyrobow, Medycznych i Produktow Biobojczych, PL-00725 WarsawRomania: National Medicines Agency, BucharestSlovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26Thailand: Ministry of Public HealthUkraine: Ministry of Health Care of Ukraine (MoH of Ukraine)United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 503
Est. completion date
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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.

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:
• linagliptin
active
• placebo
placebo

Locations
Country Name City State
Croatia 1218.16.38605 Boehringer Ingelheim Investigational Site Krapinske Toplice
Croatia 1218.16.38604 Boehringer Ingelheim Investigational Site Slavonski Brod
India 1218.16.91009 Boehringer Ingelheim Investigational Site Andhra Pradesh
India 1218.16.91002 Boehringer Ingelheim Investigational Site Bangalore
India 1218.16.91005 Boehringer Ingelheim Investigational Site Bangalore
India 1218.16.91014 Boehringer Ingelheim Investigational Site Chennai
India 1218.16.91013 Boehringer Ingelheim Investigational Site Ghaziabad
India 1218.16.91010 Boehringer Ingelheim Investigational Site Hyderabad
India 1218.16.91006 Boehringer Ingelheim Investigational Site Jaipur
India 1218.16.91011 Boehringer Ingelheim Investigational Site Maharashtra
India 1218.16.91008 Boehringer Ingelheim Investigational Site Mangalore
India 1218.16.91007 Boehringer Ingelheim Investigational Site Manipal
India 1218.16.91004 Boehringer Ingelheim Investigational Site Mumbai
India 1218.16.91003 Boehringer Ingelheim Investigational Site Nasik
India 1218.16.91012 Boehringer Ingelheim Investigational Site Tamilnadu
India 1218.16.91001 Boehringer Ingelheim Investigational Site Trivandrum, Kerala
Israel 1218.16.97267 Boehringer Ingelheim Investigational Site Givataim
Israel 1218.16.97263 Boehringer Ingelheim Investigational Site Haifa
Israel 1218.16.97265 Boehringer Ingelheim Investigational Site Holon
Israel 1218.16.97261 Boehringer Ingelheim Investigational Site Jerusalem
Israel 1218.16.97262 Boehringer Ingelheim Investigational Site Nahariya
Israel 1218.16.97266 Boehringer Ingelheim Investigational Site Safed
Italy 1218.16.39004 Boehringer Ingelheim Investigational Site Catanzaro
Italy 1218.16.39008 Boehringer Ingelheim Investigational Site Genova
Italy 1218.16.39002 Boehringer Ingelheim Investigational Site Milano
Italy 1218.16.39001 Boehringer Ingelheim Investigational Site Pisa
Italy 1218.16.39006 Boehringer Ingelheim Investigational Site Roma
Malaysia 1218.16.60006 Boehringer Ingelheim Investigational Site Alor Star
Malaysia 1218.16.60003 Boehringer Ingelheim Investigational Site Kelantan Kota Bahru
Malaysia 1218.16.60001 Boehringer Ingelheim Investigational Site Kuala Lumpur
Malaysia 1218.16.60002 Boehringer Ingelheim Investigational Site Kuala Lumpur
Malaysia 1218.16.60004 Boehringer Ingelheim Investigational Site Perak
Malaysia 1218.16.60005 Boehringer Ingelheim Investigational Site Perak
Malaysia 1218.16.60007 Boehringer Ingelheim Investigational Site Pulau Pinang
Netherlands 1218.16.31009 Boehringer Ingelheim Investigational Site Andijk
Netherlands 1218.16.31024 Boehringer Ingelheim Investigational Site Castricum
Netherlands 1218.16.31006 Boehringer Ingelheim Investigational Site Deurne
Netherlands 1218.16.31001 Boehringer Ingelheim Investigational Site Ewijk
Netherlands 1218.16.31010 Boehringer Ingelheim Investigational Site Losser
Netherlands 1218.16.31003 Boehringer Ingelheim Investigational Site Oude Pekela
Netherlands 1218.16.31021 Boehringer Ingelheim Investigational Site Poortvliet
Netherlands 1218.16.31004 Boehringer Ingelheim Investigational Site Rijswijk
Netherlands 1218.16.31008 Boehringer Ingelheim Investigational Site Roelofarendsveen
Netherlands 1218.16.31002 Boehringer Ingelheim Investigational Site Wildervank
Poland 1218.16.48603 Boehringer Ingelheim Investigational Site Lublin
Poland 1218.16.48601 Boehringer Ingelheim Investigational Site Warsaw
Poland 1218.16.48604 Boehringer Ingelheim Investigational Site Zabrze
Romania 1218.16.40604 Boehringer Ingelheim Investigational Site Brasov
Romania 1218.16.40603 Boehringer Ingelheim Investigational Site Galati
Slovakia 1218.16.42103 Boehringer Ingelheim Investigational Site Banska Bystrica
Slovakia 1218.16.42102 Boehringer Ingelheim Investigational Site Bratislava
Slovakia 1218.16.42104 Boehringer Ingelheim Investigational Site Bratislava
Slovakia 1218.16.42105 Boehringer Ingelheim Investigational Site Bratislava
Slovakia 1218.16.42101 Boehringer Ingelheim Investigational Site Nove Mesto nad Vahom
Slovakia 1218.16.42106 Boehringer Ingelheim Investigational Site Samorin
Thailand 1218.16.66001 Boehringer Ingelheim Investigational Site Bangkok
Thailand 1218.16.66002 Boehringer Ingelheim Investigational Site Khon Kaen
Ukraine 1218.16.38011 Boehringer Ingelheim Investigational Site Dnepropetrovsk
Ukraine 1218.16.38002 Boehringer Ingelheim Investigational Site Kharkiv
Ukraine 1218.16.38004 Boehringer Ingelheim Investigational Site Kharkov
Ukraine 1218.16.38010 Boehringer Ingelheim Investigational Site Kharkov
Ukraine 1218.16.38001 Boehringer Ingelheim Investigational Site Kiev
Ukraine 1218.16.38005 Boehringer Ingelheim Investigational Site Kiev
Ukraine 1218.16.38008 Boehringer Ingelheim Investigational Site Kiev
Ukraine 1218.16.38009 Boehringer Ingelheim Investigational Site Kiev
Ukraine 1218.16.38012 Boehringer Ingelheim Investigational Site Kiev
Ukraine 1218.16.38003 Boehringer Ingelheim Investigational Site Lvov
Ukraine 1218.16.38006 Boehringer Ingelheim Investigational Site Vinnitsa
Ukraine 1218.16.38007 Boehringer Ingelheim Investigational Site Zaporizhzhya

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Croatia,  India,  Israel,  Italy,  Malaysia,  Netherlands,  Poland,  Romania,  Slovakia,  Thailand,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c Change From Baseline at Week 24 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. Baseline and week 24 No
Secondary HbA1c Change From Baseline at Week 6 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. Baseline and week 6 No
Secondary HbA1c Change From Baseline at Week 12 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. Baseline and week 12 No
Secondary HbA1c Change From Baseline at Week 18 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. Baseline and week 18 No
Secondary FPG Change From Baseline at Week 24 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. Baseline and week 24 No
Secondary FPG Change From Baseline at Week 6 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. Baseline and week 6 No
Secondary FPG Change From Baseline at Week 12 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. Baseline and week 12 No
Secondary FPG Change From Baseline at Week 18 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. Baseline and week 18 No
Secondary Percentage of Patients With HbA1c <7.0% at Week 24 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% Baseline and week 24 No
Secondary Percentage of Patients With HbA1c<7.0% at Week 24 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%. Baseline and week 24 No
Secondary Percentage of Patients With HbA1c <6.5% at Week 24 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%. Baseline and week 24 No
Secondary Percentage of Patients With HbA1c<6.5% at Week 24 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%. Baseline and week 24 No
Secondary Percentage of Patients With HbA1c Lowering by 0.5% at Week 24 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%. Baseline and week 24 No
Secondary Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24 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. Baseline and week 24 No
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