Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes

Phase 3

Completed

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

• Registration Number: NCT00601250
• 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 patients with type 2 diabetes mellitus with insufficient glycaemic control

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-15
• Study First Submitted QC: 2008-01-15
• Study First Posted: 2008-01-28
• 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: 2013-12
• Last Update Submitted: 2013-12-11
• Last Update Posted: 2014-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 701

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Linagliptin	linagliptin	Patients receive linagliptin 5 mg tablets once daily
Placebo	linagliptin	Patients receive placebo tablets matching linagliptin 5 mg tablets 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 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 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 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.
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%. 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 7.0% 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%
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%.
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 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%.
2 Hour Post-Prandial Glucose (PPG) Increment Over Fasting Plasma Glucose (FPG) at Week 24	Baseline and week 24	This change from baseline reflects the Week 24 (2h PPG - FPG) minus the baseline (2h PPG - FPG). Means are treatment adjusted for baseline HbA1c, baseline 2h PPG increment over FPG and previous anti-diabetic medication.
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.
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.

Trial Locations

Locations (82)

1218.17.10003 Boehringer Ingelheim Investigational Site; 🇺🇸 Chula Vista, California, United States

1218.17.10014 Boehringer Ingelheim Investigational Site; 🇺🇸 Spring Valley, California, United States

1218.17.10001 Boehringer Ingelheim Investigational Site; 🇺🇸 Walnut Creek, California, United States

1218.17.10021 Boehringer Ingelheim Investigational Site; 🇺🇸 Northglenn, Colorado, United States

1218.17.10010 Boehringer Ingelheim Investigational Site; 🇺🇸 Hollywood, Florida, United States

1218.17.10011 Boehringer Ingelheim Investigational Site; 🇺🇸 Miami, Florida, United States

1218.17.10008 Boehringer Ingelheim Investigational Site; 🇺🇸 Pembroke Pines, Florida, United States

1218.17.10017 Boehringer Ingelheim Investigational Site; 🇺🇸 Gurnee, Illinois, United States

1218.17.10006 Boehringer Ingelheim Investigational Site; 🇺🇸 Omaha, Nebraska, United States

1218.17.10012 Boehringer Ingelheim Investigational Site; 🇺🇸 Charlotte, North Carolina, United States

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