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

NCT ID: NCT00621140

Last Updated: 2014-02-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

503 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Brief Summary

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

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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linagliptin 5 mg

linagliptin 5 mg once daily

Group Type EXPERIMENTAL

linagliptin

Intervention Type DRUG

active

placebo

placebo matching linagliptin 5 mg tablets

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

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linagliptin

active

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1218.16.38605 Boehringer Ingelheim Investigational Site

Krapinske Toplice, , Croatia

Site Status

1218.16.38604 Boehringer Ingelheim Investigational Site

Slavonski Brod, , Croatia

Site Status

1218.16.91009 Boehringer Ingelheim Investigational Site

Andhra Pradesh, , India

Site Status

1218.16.91002 Boehringer Ingelheim Investigational Site

Bangalore, , India

Site Status

1218.16.91005 Boehringer Ingelheim Investigational Site

Bangalore, , India

Site Status

1218.16.91014 Boehringer Ingelheim Investigational Site

Chennai, , India

Site Status

1218.16.91013 Boehringer Ingelheim Investigational Site

Ghaziabad, , India

Site Status

1218.16.91010 Boehringer Ingelheim Investigational Site

Hyderabad, , India

Site Status

1218.16.91006 Boehringer Ingelheim Investigational Site

Jaipur, , India

Site Status

1218.16.91011 Boehringer Ingelheim Investigational Site

Maharashtra, , India

Site Status

1218.16.91008 Boehringer Ingelheim Investigational Site

Mangalore, , India

Site Status

1218.16.91007 Boehringer Ingelheim Investigational Site

Manipal, , India

Site Status

1218.16.91004 Boehringer Ingelheim Investigational Site

Mumbai, , India

Site Status

1218.16.91003 Boehringer Ingelheim Investigational Site

Nashik, , India

Site Status

1218.16.91012 Boehringer Ingelheim Investigational Site

Tamilnadu, , India

Site Status

1218.16.91001 Boehringer Ingelheim Investigational Site

Trivandrum, Kerala, , India

Site Status

1218.16.97267 Boehringer Ingelheim Investigational Site

Giv‘atayim, , Israel

Site Status

1218.16.97263 Boehringer Ingelheim Investigational Site

Haifa, , Israel

Site Status

1218.16.97265 Boehringer Ingelheim Investigational Site

Holon, , Israel

Site Status

1218.16.97261 Boehringer Ingelheim Investigational Site

Jerusalem, , Israel

Site Status

1218.16.97262 Boehringer Ingelheim Investigational Site

Nahariya, , Israel

Site Status

1218.16.97266 Boehringer Ingelheim Investigational Site

Safed, , Israel

Site Status

1218.16.39004 Boehringer Ingelheim Investigational Site

Catanzaro, , Italy

Site Status

1218.16.39008 Boehringer Ingelheim Investigational Site

Genova, , Italy

Site Status

1218.16.39002 Boehringer Ingelheim Investigational Site

Milan, , Italy

Site Status

1218.16.39001 Boehringer Ingelheim Investigational Site

Pisa, , Italy

Site Status

1218.16.39006 Boehringer Ingelheim Investigational Site

Roma, , Italy

Site Status

1218.16.60006 Boehringer Ingelheim Investigational Site

Alor Star, , Malaysia

Site Status

1218.16.60003 Boehringer Ingelheim Investigational Site

Kelantan Kota Bahru, , Malaysia

Site Status

1218.16.60001 Boehringer Ingelheim Investigational Site

Kuala Lumpur, , Malaysia

Site Status

1218.16.60002 Boehringer Ingelheim Investigational Site

Kuala Lumpur, , Malaysia

Site Status

1218.16.60004 Boehringer Ingelheim Investigational Site

Perak, , Malaysia

Site Status

1218.16.60005 Boehringer Ingelheim Investigational Site

Perak, , Malaysia

Site Status

1218.16.60007 Boehringer Ingelheim Investigational Site

Pulau Pinang, , Malaysia

Site Status

1218.16.31009 Boehringer Ingelheim Investigational Site

Andijk, , Netherlands

Site Status

1218.16.31024 Boehringer Ingelheim Investigational Site

Castricum, , Netherlands

Site Status

1218.16.31006 Boehringer Ingelheim Investigational Site

Deurne, , Netherlands

Site Status

1218.16.31001 Boehringer Ingelheim Investigational Site

Ewijk, , Netherlands

Site Status

1218.16.31010 Boehringer Ingelheim Investigational Site

Losser, , Netherlands

Site Status

1218.16.31003 Boehringer Ingelheim Investigational Site

Oude Pekela, , Netherlands

Site Status

1218.16.31021 Boehringer Ingelheim Investigational Site

Poortvliet, , Netherlands

Site Status

1218.16.31004 Boehringer Ingelheim Investigational Site

Rijswijk, , Netherlands

Site Status

1218.16.31008 Boehringer Ingelheim Investigational Site

Roelofarendsveen, , Netherlands

Site Status

1218.16.31002 Boehringer Ingelheim Investigational Site

Wildervank, , Netherlands

Site Status

1218.16.48603 Boehringer Ingelheim Investigational Site

Lublin, , Poland

Site Status

1218.16.48601 Boehringer Ingelheim Investigational Site

Warsaw, , Poland

Site Status

1218.16.48604 Boehringer Ingelheim Investigational Site

Zabrze, , Poland

Site Status

1218.16.40604 Boehringer Ingelheim Investigational Site

Brasov, , Romania

Site Status

1218.16.40603 Boehringer Ingelheim Investigational Site

Galati, , Romania

Site Status

1218.16.42103 Boehringer Ingelheim Investigational Site

Banská Bystrica, , Slovakia

Site Status

1218.16.42102 Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

Site Status

1218.16.42104 Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

Site Status

1218.16.42105 Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

Site Status

1218.16.42101 Boehringer Ingelheim Investigational Site

Nové Mesto nad Váhom, , Slovakia

Site Status

1218.16.42106 Boehringer Ingelheim Investigational Site

Šamorín, , Slovakia

Site Status

1218.16.66001 Boehringer Ingelheim Investigational Site

Bangkok, , Thailand

Site Status

1218.16.66002 Boehringer Ingelheim Investigational Site

Khon Kaen, , Thailand

Site Status

1218.16.38011 Boehringer Ingelheim Investigational Site

Dnipro, , Ukraine

Site Status

1218.16.38002 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1218.16.38004 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1218.16.38010 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1218.16.38001 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1218.16.38005 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1218.16.38008 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1218.16.38009 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1218.16.38012 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1218.16.38003 Boehringer Ingelheim Investigational Site

Lviv, , Ukraine

Site Status

1218.16.38006 Boehringer Ingelheim Investigational Site

Vinnitsa, , Ukraine

Site Status

1218.16.38007 Boehringer Ingelheim Investigational Site

Zaporizhzhya, , Ukraine

Site Status

Countries

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Croatia India Israel Italy Malaysia Netherlands Poland Romania Slovakia Thailand Ukraine

References

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Del Prato S, Patel S, Crowe S, von Eynatten M. Efficacy and safety of linagliptin according to patient baseline characteristics: A pooled analysis of three phase 3 trials. Nutr Metab Cardiovasc Dis. 2016 Oct;26(10):886-92. doi: 10.1016/j.numecd.2016.06.015. Epub 2016 Jul 1.

Reference Type DERIVED
PMID: 27484756 (View on PubMed)

Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3.

Reference Type DERIVED
PMID: 22234149 (View on PubMed)

Other Identifiers

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2007-002448-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1218.16

Identifier Type: -

Identifier Source: org_study_id

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