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

Phase 3

Completed

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

• Registration Number: NCT00621140
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-14
• Study Start: 2008-02
• Study First Submitted QC: 2008-02-13
• Study First Posted: 2008-02-22
• Primary Completion: 2009-05
• 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: 503

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 at 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 at 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 at 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.
FPG Change From Baseline at 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 at 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.
Percentage of Patients With HbA1c <7.0% at Week 24	Baseline and 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%
FPG Change From Baseline at 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 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 \>= 6.5%.
HbA1c Change From Baseline at 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 at 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-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 7.0% 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%.
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 \>= 6.5%. Only patients with baseline HbA1c \>= 6.5%.
Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24	Baseline and 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.
Percentage of Patients With HbA1c Lowering by 0.5% at Week 24	Baseline and 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%.

Trial Locations

Locations (69)

1218.16.38605 Boehringer Ingelheim Investigational Site; 🇭🇷 Krapinske Toplice, Croatia

1218.16.38604 Boehringer Ingelheim Investigational Site; 🇭🇷 Slavonski Brod, Croatia

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

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