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

Phase 3CompletedNCT00621140

Boehringer Ingelheim503 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

503

Conditions

Diabetes Mellitus, Type 2

Interventions

linagliptinDRUG

active

placeboDRUG

placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion criteria: * Male or female patients with type 2 diabetes and insufficient glycaemic control. * Age 18 or over and not older than 80 years Exclusion criteria: * Use of more than one oral antidiabetic agent within 10 weeks prior to informed consent, insulin, glitazones or GLP-1 analogues within 3 months. * Myocardial infarction, stroke or transient ischaemic attack within 6 months prior to informed consent.

Locations (69)

Outcomes

Primary Outcomes

HbA1c Change From Baseline at 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.

Time frame: Baseline and week 24

Secondary Outcomes

HbA1c Change From Baseline at 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.

Time frame: Baseline and week 6

HbA1c Change From Baseline at 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.

Time frame: Baseline and week 12

HbA1c Change From Baseline at 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.

Time frame: Baseline and week 18

FPG Change From Baseline at 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.

Time frame: Baseline and week 24

FPG Change From Baseline at 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

...and 59 more locations

Time frame: Baseline and week 6

FPG Change From Baseline at 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.

Time frame: Baseline and week 12

FPG Change From Baseline at 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.

Time frame: Baseline and week 18

Percentage of Patients With HbA1c <7.0% at 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%

Time frame: Baseline and week 24

Percentage of Patients With HbA1c<7.0% at Week 24

Time frame: Baseline and week 24

Percentage of Patients With HbA1c <6.5% at 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%.

Time frame: Baseline and week 24

Percentage of Patients With HbA1c<6.5% at Week 24

Time frame: Baseline and week 24

Percentage of Patients With HbA1c Lowering by 0.5% at 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%.

Time frame: Baseline and week 24

Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at 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.

Time frame: Baseline and week 24