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BI 1356 (Linagliptin) in Combination With Metformin and a Sulphonylurea in Type 2 Diabetes

NCT ID: NCT00602472

Last Updated: 2014-03-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1058 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Brief Summary

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The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in combination with a sulphonylurea in patients with type 2 diabetes mellitus with insufficient glycaemic control.

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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 to linagliptin 5 mg

Interventions

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linagliptin

active

Intervention Type DRUG

placebo

placebo to linagliptin 5 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male and female patients with a diagnosis of type 2 diabetes mellitus, currently treated only with a stable total daily dose of preferably\* \>/= 1500 mg metformin and a dose of a sulphonylurea drug that has been documented, by the Investigator, to be the individual maximum tolerated dose of that sulphonylurea drug. Both the dose and dosing regimen of metformin and the sulphonylurea must be stable (i.e. unchanged) for 10 weeks prior to informed consent, and must not be changed for the duration of the trial
2. Glycosylated haemoglobin A1 (HbA1c) \>/= 7.0 and \</= 10.0% at the screening Visit 1a and at Visit 2 (start of placebo run-in phase)
3. Age \>/= 18 and \</= 80 years at Visit 1a (screening)
4. BMI (Body Mass Index) \</= 40 kg/m2 at Visit 1a (screening)
5. Signed and dated written informed consent, at the latest by the date of Visit 1a, in accordance with GCP and local legislation \*Patients currently treated with a total daily dose of less than 1500 mg metformin can be included in the trial if the Investigator has documented that the dose is the maximum tolerated dose of metformin for that patient.

Exclusion Criteria

1. Myocardial infarction, stroke or TIA (transient ischaemic attack) within 6 months prior to the date of informed consent
2. Impaired hepatic function, defined by serum levels of either alanine transaminase (ALT/SGPT), aspartase transaminase (AST/SGOT), or alkaline phosphatase (ALP) above 3 times the upper limit of normal (ULN), as determined at Visit 1a
3. Renal failure or renal impairment (serum creatinine \>/= 1.5 mg/dl) as determined at Visit 1a
4. Treatment with rosiglitazone or pioglitazone within 3 months prior to the date of informed consent
5. Treatment with GLP-1 analogues (e.g. exenatide) within 3 months prior to the date of informed consent
6. Treatment with insulin within 3 months prior to the date of informed consent
7. Treatment with anti-obesity drugs (e.g. sibutramine, rimonabant, orlistat) within 3 months prior to the date of informed consent
8. Current treatment with systemic steroids (i.e. at the time of informed consent) or a change in the dosage of thyroid hormones within 6 weeks prior to the date of informed consent
9. Pre-menopausal women (last menstruation \</= 1 year prior to the date of informed consent) who:

* are nursing or pregnant
* or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to periodic pregnancy testing during their participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made.
10. Known hypersensitivity or allergy to the investigational product or its excipients or to the trial background therapy (i.e. metformin in combination with a sulphonylurea) or sulphonamides
11. Dehydration (as confirmed by the Investigators clinical opinion)
12. Current acute or chronic metabolic acidosis
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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1218.18.54001 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

1218.18.54002 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

1218.18.54004 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

1218.18.54005 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

1218.18.54010 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

1218.18.54014 Boehringer Ingelheim Investigational Site

Corrientes, , Argentina

Site Status

1218.18.54009 Boehringer Ingelheim Investigational Site

Córdoba, , Argentina

Site Status

1218.18.54013 Boehringer Ingelheim Investigational Site

Córdoba, , Argentina

Site Status

1218.18.54003 Boehringer Ingelheim Investigational Site

Mar del Plata, , Argentina

Site Status

1218.18.54012 Boehringer Ingelheim Investigational Site

Mar del Plata, , Argentina

Site Status

1218.18.54011 Boehringer Ingelheim Investigational Site

Mendoza, , Argentina

Site Status

1218.18.54015 Boehringer Ingelheim Investigational Site

Parque Velez Sarfield, , Argentina

Site Status

1218.18.54006 Boehringer Ingelheim Investigational Site

Rosario, , Argentina

Site Status

1218.18.54007 Boehringer Ingelheim Investigational Site

Salta, , Argentina

Site Status

1218.18.32005 Boehringer Ingelheim Investigational Site

Bruges, , Belgium

Site Status

1218.18.32007 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

1218.18.32006 Boehringer Ingelheim Investigational Site

Edegem, , Belgium

Site Status

1218.18.32004 Boehringer Ingelheim Investigational Site

Genk, , Belgium

Site Status

1218.18.32003 Boehringer Ingelheim Investigational Site

Ghent, , Belgium

Site Status

1218.18.32002 Boehringer Ingelheim Investigational Site

Huy, , Belgium

Site Status

1218.18.32001 Boehringer Ingelheim Investigational Site

Liège, , Belgium

Site Status

1218.18.01005 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Site Status

1218.18.01010 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Site Status

1218.18.01003 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1218.18.01011 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1218.18.01006 Boehringer Ingelheim Investigational Site

Etobicoke, Ontario, Canada

Site Status

1218.18.01009 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

1218.18.01002 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Site Status

1218.18.01012 Boehringer Ingelheim Investigational Site

Oakville, Ontario, Canada

Site Status

1218.18.01008 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Site Status

1218.18.01001 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1218.18.01004 Boehringer Ingelheim Investigational Site

Montague, Prince Edward Island, Canada

Site Status

1218.18.01007 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Site Status

1218.18.86001 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1218.18.86002 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1218.18.86004 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1218.18.86013 Boehringer Ingelheim Investigational Site

Chengdu, Sichuan Province, , China

Site Status

1218.18.86009 Boehringer Ingelheim Investigational Site

Dalian, , China

Site Status

1218.18.86011 Boehringer Ingelheim Investigational Site

Guangzhou, , China

Site Status

1218.18.86014 Boehringer Ingelheim Investigational Site

Haerbin, , China

Site Status

1218.18.86005 Boehringer Ingelheim Investigational Site

Nanjing, Jiangsu Province, , China

Site Status

1218.18.86008 Boehringer Ingelheim Investigational Site

Qingdao, , China

Site Status

1218.18.86015 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1218.18.86010 Boehringer Ingelheim Investigational Site

Shenyang, , China

Site Status

1218.18.86003 Boehringer Ingelheim Investigational Site

Weizikeng, , China

Site Status

1218.18.86007 Boehringer Ingelheim Investigational Site

Wuhan, , China

Site Status

1218.18.86012 Boehringer Ingelheim Investigational Site

Wuhan, Hubei Province, , China

Site Status

1218.18.86006 Boehringer Ingelheim Investigational Site

Xian, Shanxi Province, , China

Site Status

1218.18.49004 Boehringer Ingelheim Investigational Site

Aschaffenburg, , Germany

Site Status

1218.18.49028 Boehringer Ingelheim Investigational Site

Bad Mergentheim, , Germany

Site Status

1218.18.49022 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1218.18.49024 Boehringer Ingelheim Investigational Site

Bosenheim, , Germany

Site Status

1218.18.49020 Boehringer Ingelheim Investigational Site

Dresden, , Germany

Site Status

1218.18.49101 Boehringer Ingelheim Investigational Site

Mainz, , Germany

Site Status

1218.18.49003 Boehringer Ingelheim Investigational Site

Neuwied, , Germany

Site Status

1218.18.49007 Boehringer Ingelheim Investigational Site

Nuremberg, , Germany

Site Status

1218.18.49014 Boehringer Ingelheim Investigational Site

Saarbrücken, , Germany

Site Status

1218.18.63005 Boehringer Ingelheim Investigational Site

Manila, , Philippines

Site Status

1218.18.63002 Boehringer Ingelheim Investigational Site

Marikina City, , Philippines

Site Status

1218.18.63001 Boehringer Ingelheim Investigational Site

Pasig, , Philippines

Site Status

1218.18.63004 Boehringer Ingelheim Investigational Site

Quezon City, , Philippines

Site Status

1218.18.63003 Boehringer Ingelheim Investigational Site

San Juan City, , Philippines

Site Status

1218.18.70014 Boehringer Ingelheim Investigational Site

Arkhangelsk, , Russia

Site Status

1218.18.70012 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1218.18.70013 Boehringer Ingelheim Investigational Site

Rostov-on-Don, , Russia

Site Status

1218.18.70015 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1218.18.70016 Boehringer Ingelheim Investigational Site

Samara, , Russia

Site Status

1218.18.82004 Boehringer Ingelheim Investigational Site

Busan, , South Korea

Site Status

1218.18.82011 Boehringer Ingelheim Investigational Site

Daegu, , South Korea

Site Status

1218.18.82008 Boehringer Ingelheim Investigational Site

Incheon, , South Korea

Site Status

1218.18.82010 Boehringer Ingelheim Investigational Site

Jeonju, , South Korea

Site Status

1218.18.82002 Boehringer Ingelheim Investigational Site

Pusan, , South Korea

Site Status

1218.18.82001 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1218.18.82005 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1218.18.82006 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1218.18.82007 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1218.18.82009 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1218.18.82003 Boehringer Ingelheim Investigational Site

Suwon, , South Korea

Site Status

1218.18.88605 Boehringer Ingelheim Investigational Site

Changhua, , Taiwan

Site Status

1218.18.88604 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

Site Status

1218.18.88606 Boehringer Ingelheim Investigational Site

Tainan City, , Taiwan

Site Status

1218.18.88601 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1218.18.88602 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1218.18.88603 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1218.18.88607 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1218.18.88608 Boehringer Ingelheim Investigational Site

Taoyuan District, , Taiwan

Site Status

1218.18.90003 Boehringer Ingelheim Investigational Site

Erzurum, , Turkey (Türkiye)

Site Status

1218.18.90005 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

1218.18.90001 Boehringer Ingelheim Investigational Site

Izmir, , Turkey (Türkiye)

Site Status

1218.18.90004 Boehringer Ingelheim Investigational Site

Konya, , Turkey (Türkiye)

Site Status

1218.18.44005 Boehringer Ingelheim Investigational Site

Ashford, , United Kingdom

Site Status

1218.18.44004 Boehringer Ingelheim Investigational Site

Baillieston, Glasgow, , United Kingdom

Site Status

1218.18.44001 Boehringer Ingelheim Investigational Site

Bath, , United Kingdom

Site Status

1218.18.44003 Boehringer Ingelheim Investigational Site

Burbage, , United Kingdom

Site Status

1218.18.44010 Boehringer Ingelheim Investigational Site

Bury Saint Edmonds, , United Kingdom

Site Status

1218.18.44009 Boehringer Ingelheim Investigational Site

Cardiff, , United Kingdom

Site Status

1218.18.44008 Boehringer Ingelheim Investigational Site

Glasgow, , United Kingdom

Site Status

1218.18.44002 Boehringer Ingelheim Investigational Site

Penarth, , United Kingdom

Site Status

1218.18.44006 Boehringer Ingelheim Investigational Site

Reading, , United Kingdom

Site Status

1218.18.44007 Boehringer Ingelheim Investigational Site

Waterloo, Liverpool, , United Kingdom

Site Status

Countries

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Argentina Belgium Canada China Germany Philippines Russia South Korea Taiwan Turkey (Türkiye) United Kingdom

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)

Zeng Z, Yang JK, Tong N, Yan S, Zhang X, Gong Y, Woerle HJ. Efficacy and safety of linagliptin added to metformin and sulphonylurea in Chinese patients with type 2 diabetes: a sub-analysis of data from a randomised clinical trial. Curr Med Res Opin. 2013 Aug;29(8):921-9. doi: 10.1185/03007995.2013.805123. Epub 2013 Jun 4.

Reference Type DERIVED
PMID: 23672632 (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)

Owens DR, Swallow R, Dugi KA, Woerle HJ. Efficacy and safety of linagliptin in persons with type 2 diabetes inadequately controlled by a combination of metformin and sulphonylurea: a 24-week randomized study. Diabet Med. 2011 Nov;28(11):1352-61. doi: 10.1111/j.1464-5491.2011.03387.x.

Reference Type DERIVED
PMID: 21781152 (View on PubMed)

Other Identifiers

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2007-002450-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1218.18

Identifier Type: -

Identifier Source: org_study_id

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