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

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): 1218.65.86007 Boehringer Ingelheim Investigational Site
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Beijing, China
1218.65.86011 Boehringer Ingelheim Investigational Site
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Chongqing, China
1218.65.86008 Boehringer Ingelheim Investigational Site
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Dalian, China
1218.65.86010 Boehringer Ingelheim Investigational Site
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Fuzhou, China
1218.65.86014 Boehringer Ingelheim Investigational Site
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Hangzhou, China
1218.65.86005 Boehringer Ingelheim Investigational Site
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Hefei, China
1218.65.86006 Boehringer Ingelheim Investigational Site
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Hefei, China
1218.65.86012 Boehringer Ingelheim Investigational Site
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Nanjing, China
1218.65.86001 Boehringer Ingelheim Investigational Site
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Shanghai, China
1218.65.86002 Boehringer Ingelheim Investigational Site
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Shanghai, China
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1218.65.86007 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China