Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes
NCT ID: NCT00601250
Last Updated: 2014-01-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
701 participants
INTERVENTIONAL
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Linagliptin
Patients receive linagliptin 5 mg tablets once daily
linagliptin
Patients receive linagliptin 5 mg tablets once daily
Placebo
Patients receive placebo tablets matching linagliptin 5 mg tablets once daily
linagliptin
Patients receive linagliptin 5 mg tablets once daily
Interventions
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linagliptin
Patients receive linagliptin 5 mg tablets once daily
linagliptin
Patients receive linagliptin 5 mg tablets once daily
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of type 2 diabetes prior to informed consent
3. Glycosylated haemoglobin A1 (HbA1c)at screening:
For patients undergoing wash out of previous medication: HbA1c 6.5 - 9.0% For patients not undergoing wash-out of previous medication: HbA1c 7.0 - 10.0%
4. Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at the beginning of Placebo Run-in
5. Age 18 -80 years
6. BMI (Body Mass Index) less than 40 kg/m2
7. Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation
Exclusion Criteria
2. Impaired hepatic function
3. Known hypersensitivity or allergy to the investigational product or its excipients or metformin or placebo
4. Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
5. Treatment with an injectable GLP-1 analogue (e.g. exenatide) within 3 months prior to informed consent
6. Treatment with insulin within 3 months prior to informed consent
7. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent
8. Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse
9. Participation in another trial with an investigational drug within 2 months prior to informed consent
10. Pre-menopausal women 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 submit to periodic pregnancy testing during participation in the trial.
11. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
12. Renal failure or renal impairment
13. Unstable or acute congestive heart failure
14. Acute or chronic metabolic acidosis (present in patient history)
15. Hereditary galactose intolerance
18 Years
80 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
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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1218.17.10003 Boehringer Ingelheim Investigational Site
Chula Vista, California, United States
1218.17.10014 Boehringer Ingelheim Investigational Site
Spring Valley, California, United States
1218.17.10001 Boehringer Ingelheim Investigational Site
Walnut Creek, California, United States
1218.17.10021 Boehringer Ingelheim Investigational Site
Northglenn, Colorado, United States
1218.17.10010 Boehringer Ingelheim Investigational Site
Hollywood, Florida, United States
1218.17.10011 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1218.17.10008 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States
1218.17.10017 Boehringer Ingelheim Investigational Site
Gurnee, Illinois, United States
1218.17.10006 Boehringer Ingelheim Investigational Site
Omaha, Nebraska, United States
1218.17.10012 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina, United States
1218.17.10013 Boehringer Ingelheim Investigational Site
Mentor, Ohio, United States
1218.17.10015 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
1218.17.10016 Boehringer Ingelheim Investigational Site
Eugene, Oregon, United States
1218.17.10002 Boehringer Ingelheim Investigational Site
Greer, South Carolina, United States
1218.17.10004 Boehringer Ingelheim Investigational Site
Simpsonville, South Carolina, United States
1218.17.10005 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1218.17.10018 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1218.17.10007 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
1218.17.10009 Boehringer Ingelheim Investigational Site
Federal Way, Washington, United States
1218.17.42001 Boehringer Ingelheim Investigational Site
Brno, , Czechia
1218.17.42004 Boehringer Ingelheim Investigational Site
Brno, , Czechia
1218.17.42007 Boehringer Ingelheim Investigational Site
Brno, , Czechia
1218.17.42009 Boehringer Ingelheim Investigational Site
Brno, , Czechia
1218.17.42006 Boehringer Ingelheim Investigational Site
Břeclav, , Czechia
1218.17.42008 Boehringer Ingelheim Investigational Site
Hodonín, , Czechia
1218.17.42003 Boehringer Ingelheim Investigational Site
Olomouc, , Czechia
1218.17.35806 Boehringer Ingelheim Investigational Site
Helsinki, , Finland
1218.17.35804 Boehringer Ingelheim Investigational Site
Jyväskylä, , Finland
1218.17.35801 Boehringer Ingelheim Investigational Site
Kuopio, , Finland
1218.17.35803 Boehringer Ingelheim Investigational Site
Oulu, , Finland
1218.17.35805 Boehringer Ingelheim Investigational Site
Seinäjoki, , Finland
1218.17.35802 Boehringer Ingelheim Investigational Site
Turku, , Finland
1218.17.30004 Boehringer Ingelheim Investigational Site
Athens, , Greece
1218.17.30013 Boehringer Ingelheim Investigational Site
Athens, , Greece
1218.17.30011 Boehringer Ingelheim Investigational Site
Piraeus, , Greece
1218.17.91009 Boehringer Ingelheim Investigational Site
Andhra Pradesh, , India
1218.17.91002 Boehringer Ingelheim Investigational Site
Bangalore, , India
1218.17.91005 Boehringer Ingelheim Investigational Site
Bangalore, , India
1218.17.91012 Boehringer Ingelheim Investigational Site
Chennai, , India
1218.17.91014 Boehringer Ingelheim Investigational Site
Chennai, , India
1218.17.91010 Boehringer Ingelheim Investigational Site
Hyderabad, , India
1218.17.91006 Boehringer Ingelheim Investigational Site
Jaipur, , India
1218.17.91007 Boehringer Ingelheim Investigational Site
Karnataka, , India
1218.17.91008 Boehringer Ingelheim Investigational Site
Mangalore, , India
1218.17.91004 Boehringer Ingelheim Investigational Site
Mumbai, , India
1218.17.91011 Boehringer Ingelheim Investigational Site
Nagpur, , India
1218.17.91003 Boehringer Ingelheim Investigational Site
Nashik, , India
1218.17.91001 Boehringer Ingelheim Investigational Site
Trivandrum, , India
1218.17.91013 Boehringer Ingelheim Investigational Site
Uttar Pradesh, , India
1218.17.97274 Boehringer Ingelheim Investigational Site
Afula, , Israel
1218.17.97273 Boehringer Ingelheim Investigational Site
Haifa, , Israel
1218.17.97275 Boehringer Ingelheim Investigational Site
Holon, , Israel
1218.17.97271 Boehringer Ingelheim Investigational Site
Jerusalem, , Israel
1218.17.97272 Boehringer Ingelheim Investigational Site
Nahariya, , Israel
1218.17.97276 Boehringer Ingelheim Investigational Site
Safed, , Israel
1218.17.97278 Boehringer Ingelheim Investigational Site
Tel Aviv, , Israel
1218.17.52007 Boehringer Ingelheim Investigational Site
Aguascalientes, Ags., , Mexico
1218.17.52009 Boehringer Ingelheim Investigational Site
cOL OBREGON,León, Guanajuato, , Mexico
1218.17.52003 Boehringer Ingelheim Investigational Site
Col. Lomas de San Francisco, Monterrey, , Mexico
1218.17.52001 Boehringer Ingelheim Investigational Site
Col. Mitras Centro, Monterrey, N.L., , Mexico
1218.17.52010 Boehringer Ingelheim Investigational Site
Col.Americana, Guadalajara, Jalisco, , Mexico
1218.17.52008 Boehringer Ingelheim Investigational Site
Colonia Tlalpan, Mexico, , Mexico
1218.17.52006 Boehringer Ingelheim Investigational Site
Faccionamiento Lomas de Campestre,AGUASCAL, , Mexico
1218.17.52005 Boehringer Ingelheim Investigational Site
Lomas de Reforma, , Mexico
1218.17.52002 Boehringer Ingelheim Investigational Site
México, , Mexico
1218.17.52004 Boehringer Ingelheim Investigational Site
Tlalpan-México D,F, , Mexico
1218.17.64004 Boehringer Ingelheim Investigational Site
Christchurch, , New Zealand
1218.17.64003 Boehringer Ingelheim Investigational Site
Dunedin, , New Zealand
1218.17.64002 Boehringer Ingelheim Investigational Site
Otahuhu, , New Zealand
1218.17.64001 Boehringer Ingelheim Investigational Site
Tauranga, , New Zealand
1218.17.64005 Boehringer Ingelheim Investigational Site
Wellington, , New Zealand
1218.17.70001 Boehringer Ingelheim Investigational Site
Moscow, , Russia
1218.17.70002 Boehringer Ingelheim Investigational Site
Moscow, , Russia
1218.17.70003 Boehringer Ingelheim Investigational Site
Moscow, , Russia
1218.17.70005 Boehringer Ingelheim Investigational Site
Novosibirsk, , Russia
1218.17.70006 Boehringer Ingelheim Investigational Site
Perm, , Russia
1218.17.70004 Boehringer Ingelheim Investigational Site
Tomsk, , Russia
1218.17.46013 Boehringer Ingelheim Investigational Site
Härnösand, , Sweden
1218.17.46001 Boehringer Ingelheim Investigational Site
Malmo, , Sweden
1218.17.46012 Boehringer Ingelheim Investigational Site
Uddevalla, , Sweden
1218.17.46004 Boehringer Ingelheim Investigational Site
Uppsala, , Sweden
1218.17.46015 Boehringer Ingelheim Investigational Site
Uppsala, , Sweden
Countries
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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.
Other Identifiers
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2007-002457-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1218.17
Identifier Type: -
Identifier Source: org_study_id
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