Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy

Phase 3

Completed

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

• Registration Number: NCT01215097
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

In this randomised, double-blind, parallel group trial, the safety and efficacy of 5 mg of Linagliptin administered orally once daily will be compared with a placebo after 24 weeks of treatment as add-on therapy to metformin in patients with type 2 diabetes and insufficient glycaemic control.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-28
• Study Start: 2010-10
• Study First Submitted QC: 2010-10-05
• Study First Posted: 2010-10-06
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Results First Submitted: 2013-04-16
• Results First Submitted QC: 2013-04-16
• Results First Posted: 2013-06-03
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	once a day
Linagliptin	Linagliptin	once a day

Primary Outcome Measures

Name	Time	Method
HbA1c Change From Baseline at Week 24	Baseline and at week 24	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 at week 6	Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
FPG Change From Baseline at Week 24	Baseline and at week 24	Means are treatment adjusted for baseline fasting plasma glucose (FPG) and previous anti-diabetic medication.
FPG Change From Baseline at Week 12	Baseline and at week 12	Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.
Number of Patients With HbA1c < 7.0%	baseline and at week 24	Number of patients with HbA1c \< 7.0% at week 24
HbA1c Change From Baseline at Week 24(Chinese Only)	Baseline and at 24 weeks	Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
FPG Change From Baseline at Week 18	Baseline and at week 18	Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.
HbA1c Change From Baseline at Week 12	Baseline and at week 12	Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Number of Patients With HbA1c < 7.0% at Week 24 With Baseline HbA1c >= 7.0%.	baseline and at week 24	Number of patients with HbA1c \< 7.0% at week 24 with baseline HbA1c \>= 7.0%.
HbA1c Change From Baseline at Week 18	Baseline and at week 18	Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
FPG Change From Baseline at Week 6	Baseline and at week 6	Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.
Number of Patients With HbA1c < 6.5%	baseline and at week 24	Number of patients with HbA1c \< 6.5% at week 24
Number of Patients With HbA1c < 6.5% at Week 24 With Baseline HbA1c >= 6.5%.	baseline and at week 24	Number of patients with HbA1c \< 6.5% at week 24 with baseline HbA1c \>= 6.5%.
Number With HbA1c at Least Lowering 0.5%	baseline and at week 24	Number with HbA1c at least 0.5% lowering from baseline at week 24

Trial Locations

Locations (19)

1218.65.86008 Boehringer Ingelheim Investigational Site; 🇨🇳 Dalian, China

1218.65.86007 Boehringer Ingelheim Investigational Site; 🇨🇳 Beijing, China

1218.65.86011 Boehringer Ingelheim Investigational Site; 🇨🇳 Chongqing, China

1218.65.86014 Boehringer Ingelheim Investigational Site; 🇨🇳 Hangzhou, China

1218.65.86001 Boehringer Ingelheim Investigational Site; 🇨🇳 Shanghai, China

1218.65.86003 Boehringer Ingelheim Investigational Site; 🇨🇳 Shanghai, China

1218.65.86009 Boehringer Ingelheim Investigational Site; 🇨🇳 Wuhan, China

1218.65.86004 Boehringer Ingelheim Investigational Site; 🇨🇳 Suzhou, China

1218.65.60002 Boehringer Ingelheim Investigational Site; 🇲🇾 Johor Bahru,, Malaysia

1218.65.63001 Boehringer Ingelheim Investigational Site; 🇵🇭 Marikina, Philippines

1218.65.86010 Boehringer Ingelheim Investigational Site; 🇨🇳 Fuzhou, China

1218.65.86005 Boehringer Ingelheim Investigational Site; 🇨🇳 Hefei, China

1218.65.86006 Boehringer Ingelheim Investigational Site; 🇨🇳 Hefei, China

1218.65.86002 Boehringer Ingelheim Investigational Site; 🇨🇳 Shanghai, China

1218.65.86015 Boehringer Ingelheim Investigational Site; 🇨🇳 Wenzhou, China

1218.65.86013 Boehringer Ingelheim Investigational Site; 🇨🇳 Yangzhou, China

1218.65.63002 Boehringer Ingelheim Investigational Site; 🇵🇭 San Juan, Philippines

1218.65.60001 Boehringer Ingelheim Investigational Site; 🇲🇾 Kelantan, Malaysia

1218.65.86012 Boehringer Ingelheim Investigational Site; 🇨🇳 Nanjing, China