Efficacy vs Placebo as Initial Combination Therapy With Pioglitazone
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: Linagliptin + pioglitazone (30 mg)Drug: placebo + pioglitazone (30 mg)
- Registration Number
- NCT00641043
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (Linagliptin) (5 mg / once daily) compared to placebo given for 24 weeks as initial combination therapy with pioglitazone 30 mg in patients with type 2 diabetes mellitus with insufficient glycaemic control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 389
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 1356 (5 mg) Linagliptin + pioglitazone (30 mg) BI 1356 5mg in initial combination therapy with pioglitazone 30 mg Placebo matching BI 1356 5 mg placebo + pioglitazone (30 mg) Placebo in initial combination therapy with pioglitazone 30 mg
- Primary Outcome Measures
Name Time Method HbA1c Change From Baseline to Week 24 Baseline and 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.
- Secondary Outcome Measures
Name Time Method FPG Change From Baseline to Week 18 Baseline and 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-diabetes medication.
Percentage of Patients With HbA1c <7.0% at Week 24 Baseline and Week 24 The percentage of patients with an HbA1c value below 7% 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 above 7%. Only patients with baseline HbA1c \>= 7%
Percentage of Patients With HbA1c <6.5% at Week 24 Baseline and 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 above 6.5%. Only patients with baseline HbA1c \>= 6.5%
HbA1c Change From Baseline to Week 6 Baseline and 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.
HbA1c Change From Baseline to Week 12 Baseline and 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.
HbA1c Change From Baseline to Week 18 Baseline and 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.
FPG Change From Baseline to Week 12 Baseline and 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.
FPG Change From Baseline to Week 6 Baseline and 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.
Percentage of Patients With HbA1c<7.0 at Week 24 Baseline and Week 24 The percentage of patients with an HbA1c value below 7% 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 above 7%.
Percentage of Patients With HbA1c<6.5% at Week 24 Baseline and 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 above 6.5%
FPG Change From Baseline to Week 24 Baseline and 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.
Percentage of Patients Who Have an HbA1c Lowering by 0.5% at Week 24 Baseline and Week 24 The percentage of patients with an HbA1c reduction from baseline greater than 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%.
Trial Locations
- Locations (43)
1218.15.36002 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡ºSzombathely, Hungary
1218.15.34006 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1218.15.30006 Boehringer Ingelheim Investigational Site
🇬🇷Thessaloniki, Greece
1218.15.40504 Boehringer Ingelheim Investigational Site
🇷🇴Alba Iulia, Romania
1218.15.34011 Boehringer Ingelheim Investigational Site
🇪🇸Badia del Vallés, Spain
1218.15.36006 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡ºBudapest, Hungary
1218.15.34009 Boehringer Ingelheim Investigational Site
🇪🇸L'Hospitalet de Llobregat (Barcelona), Spain
1218.15.34010 Boehringer Ingelheim Investigational Site
🇪🇸Sant Adrià del Besós (Barcelona), Spain
1218.15.34001 Boehringer Ingelheim Investigational Site
🇪🇸Bercelona, Spain
1218.15.34013 Boehringer Ingelheim Investigational Site
🇪🇸Centelles, Spain
1218.15.34002 Boehringer Ingelheim Investigational Site
🇪🇸Badalona, Spain
1218.15.34007 Boehringer Ingelheim Investigational Site
🇪🇸Granada, Spain
1218.15.34005 Boehringer Ingelheim Investigational Site
🇪🇸Sevilla, Spain
1218.15.34004 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1218.15.30007 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1218.15.30003 Boehringer Ingelheim Investigational Site
🇬🇷Nikaia, Greece
1218.15.81001 Boehringer Ingelheim Investigational Site
🇯🇵Amagasaki, Hyogo, Japan
1218.15.81003 Boehringer Ingelheim Investigational Site
🇯🇵Suita, Osaka,, Japan
1218.15.34014 Boehringer Ingelheim Investigational Site
🇪🇸Vic (Barcelona), Spain
1218.15.34008 Boehringer Ingelheim Investigational Site
🇪🇸L'Hospitalet de Llobregat (Barcelona), Spain
1218.15.30004 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1218.15.34012 Boehringer Ingelheim Investigational Site
🇪🇸Borges del Camp, Spain
1218.15.43004 Boehringer Ingelheim Investigational Site
🇦🇹Feldkirch, Austria
1218.15.30014 Boehringer Ingelheim Investigational Site
🇬🇷Thessaloniki, Greece
1218.15.81005 Boehringer Ingelheim Investigational Site
🇯🇵Koganei, Tokyo, Japan
1218.15.35001 Boehringer Ingelheim Investigational Site
🇵🇹Lisboa, Portugal
1218.15.40505 Boehringer Ingelheim Investigational Site
🇷🇴Targu-Mures, Romania
1218.15.30002 Boehringer Ingelheim Investigational Site
🇬🇷Melissia-Athens, Greece
1218.15.36005 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡ºGyör, Hungary
1218.15.81002 Boehringer Ingelheim Investigational Site
🇯🇵Osaka, Osaka, Japan
1218.15.36003 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡ºBudapest, Hungary
1218.15.36004 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡ºBudapest, Hungary
1218.15.81004 Boehringer Ingelheim Investigational Site
🇯🇵Shinjyuku-ku,Tokyo, Japan
1218.15.43001 Boehringer Ingelheim Investigational Site
🇦🇹Graz, Austria
1218.15.43005 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1218.15.30017 Boehringer Ingelheim Investigational Site
🇬🇷Ioannina, Greece
1218.15.30016 Boehringer Ingelheim Investigational Site
🇬🇷Thessaloniki, Greece
1218.15.36008 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡ºDebrecen, Hungary
1218.15.40501 Boehringer Ingelheim Investigational Site
🇷🇴Bucharest, Romania
1218.15.43003 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1218.15.35007 Boehringer Ingelheim Investigational Site
🇵🇹Aveiro, Portugal
1218.15.40502 Boehringer Ingelheim Investigational Site
🇷🇴Bucharest, Romania
1218.15.40503 Boehringer Ingelheim Investigational Site
🇷🇴Sibiu, Romania