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Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT00621140
Date of registration:	14/01/2008
Prospective Registration:	Yes
Primary sponsor:	Boehringer Ingelheim
Public title:	Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control
Scientific title:	A Randomised, Double-blind, Placebo-controled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 24 Weeks, in Drug Naive or Previously Treated (6 Weeks Washout) Type 2 Diabetic Patients With Insufficient Glycemic Control
Date of first enrolment:	February 2008
Target sample size:	503
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00621140
Study type:	Interventional
Study design:
Phase:	Phase 3

Countries of recruitment
Croatia	India	Israel	Italy	Malaysia	Netherlands	Poland	Romania
Slovakia	Thailand	Ukraine

Contacts

Name:	Boehringer Ingelheim
Address:
Telephone:
Email:
Affiliation:	Boehringer Ingelheim

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Drug: linagliptin

Drug: placebo

Primary Outcome(s)

HbA1c Change From Baseline at Week 24 [Time Frame: Baseline and week 24]

Secondary Outcome(s)

FPG Change From Baseline at Week 18 [Time Frame: Baseline and week 18]

HbA1c Change From Baseline at Week 18 [Time Frame: Baseline and week 18]

FPG Change From Baseline at Week 24 [Time Frame: Baseline and week 24]

FPG Change From Baseline at Week 6 [Time Frame: Baseline and week 6]

Percentage of Patients With HbA1c<6.5% at Week 24 [Time Frame: Baseline and week 24]

FPG Change From Baseline at Week 12 [Time Frame: Baseline and week 12]

HbA1c Change From Baseline at Week 12 [Time Frame: Baseline and week 12]

HbA1c Change From Baseline at Week 6 [Time Frame: Baseline and week 6]

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 [Time Frame: Baseline and week 24]

Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24 [Time Frame: Baseline and week 24]

Percentage of Patients With HbA1c Lowering by 0.5% at Week 24 [Time Frame: Baseline and week 24]

Percentage of Patients With HbA1c <7.0% at Week 24 [Time Frame: Baseline and week 24]

Secondary ID(s)

2007-002448-10

1218.16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	07/06/2011
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT00621140

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