Efficacy vs Placebo as Initial Combination Therapy With Pioglitazone

Phase 3

Completed

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2008-02-29
• Study Start: 2008-03
• Study First Submitted QC: 2008-03-20
• Study First Posted: 2008-03-21
• Primary Completion: 2009-06
• Results First Submitted: 2011-05-13
• Results First Submitted QC: 2011-05-13
• Results First Posted: 2011-06-07
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-22
• Last Update Posted: 2014-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 389

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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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; 🇭🇺 Szombathely, 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; 🇭🇺 Budapest, 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; 🇭🇺 Györ, Hungary

1218.15.81002 Boehringer Ingelheim Investigational Site; 🇯🇵 Osaka, Osaka, Japan

1218.15.36003 Boehringer Ingelheim Investigational Site; 🇭🇺 Budapest, Hungary

1218.15.36004 Boehringer Ingelheim Investigational Site; 🇭🇺 Budapest, 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; 🇭🇺 Debrecen, 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