BI 1356 (Linagliptin) in Combination With Metformin and a Sulphonylurea in Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: placebo; Drug: linagliptin

• Registration Number: NCT00602472
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in combination with a sulphonylurea in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-15
• Study First Submitted QC: 2008-01-25
• Study First Posted: 2008-01-28
• Study Start: 2008-02
• Primary Completion: 2009-05
• Results First Submitted: 2011-05-13
• Results First Submitted QC: 2011-05-13
• Results First Posted: 2011-06-15
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-27
• Last Update Posted: 2014-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1058

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo matching linagliptin 5 mg tablets
linagliptin 5 mg	linagliptin	linagliptin 5 mg once daily

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
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 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.
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.
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 18	Baseline and week 18	This change from baseline reflects the Week 18 FPG minus the Week 0 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%. Only patients with baseline HbA1c \>= 7%
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%. Only patients with baseline HbA1c \>= 6.5%
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%
Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24	Baseline and week 24	The percentage of patients with an HbA1c reduction greater than 0.5% at week 24 from baseline 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 (100)

1218.18.54001 Boehringer Ingelheim Investigational Site; 🇦🇷 Capital Federal, Argentina

1218.18.54002 Boehringer Ingelheim Investigational Site; 🇦🇷 Capital Federal, Argentina

1218.18.54004 Boehringer Ingelheim Investigational Site; 🇦🇷 Capital Federal, Argentina

1218.18.54005 Boehringer Ingelheim Investigational Site; 🇦🇷 Capital Federal, Argentina

1218.18.54010 Boehringer Ingelheim Investigational Site; 🇦🇷 Capital Federal, Argentina

1218.18.54014 Boehringer Ingelheim Investigational Site; 🇦🇷 Corrientes, Argentina

1218.18.54009 Boehringer Ingelheim Investigational Site; 🇦🇷 Córdoba, Argentina

1218.18.54013 Boehringer Ingelheim Investigational Site; 🇦🇷 Córdoba, Argentina

1218.18.54003 Boehringer Ingelheim Investigational Site; 🇦🇷 Mar del Plata, Argentina

1218.18.54012 Boehringer Ingelheim Investigational Site; 🇦🇷 Mar del Plata, Argentina

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