MedDataX Logo

Linagliptin 2.5 mg Twice Daily Versus 5 mg Once Daily as add-on Therapy to Twice Daily Metformin in Type 2 Diabetes

NCT ID: NCT01012037

Last Updated: 2014-06-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

491 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily compared to 5 mg once daily and each treatment's superiority over placebo.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01215097

Diabetes Mellitus, Type 2
COMPLETED PHASE3

Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients

NCT00328172

Diabetes Mellitus, Type 2
COMPLETED PHASE2

Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes

NCT00309608

Diabetes Mellitus, Type 2
COMPLETED PHASE2

Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design

NCT00798161

Diabetes Mellitus, Type 2
COMPLETED PHASE3

Linagliptin in Combination With Metformin in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

NCT01438814

Diabetes Mellitus, Type 2
COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

linagliptin low dose

linagliptin low dose twice daily

Group Type EXPERIMENTAL

linagliptin low dose

Intervention Type DRUG

patient to receive tablets containing low dose linagliptin twice daily

placebo

placebo matching linagliptin

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

patient to receive placebo tablet(s) matching linagliptin

linagliptin medium dose

linagliptin medium dose once daily

Group Type EXPERIMENTAL

linagliptin medium dose

Intervention Type DRUG

patient to receive a tablet containing medium dose linagliptin once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

linagliptin low dose

patient to receive tablets containing low dose linagliptin twice daily

Intervention Type DRUG

placebo

patient to receive placebo tablet(s) matching linagliptin

Intervention Type DRUG

linagliptin medium dose

patient to receive a tablet containing medium dose linagliptin once daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Diagnosis of type 2 diabetes mellitus.
2. Current treatment with metformin alone (\>/= 1500 mg or maximally tolerated dose) or metformin plus 1 other antidiabetic drug. Metformin must be administered in twice daily dosing regimen. Patients taking metformin three times daily can be included if posology is switched to twice daily and total daily dose is maintained.
3. Glycosylated haemoglobin (HbA1c) is between 7.0% - 10.0%.
4. Body Mass Index (BMI) \</=45 kg/m2.

Exclusion Criteria

1. Treatment with extended release metformin.
2. Uncontrolled hyperglycaemia (fasting plasma glucose \> 240 mg/dL or 13.3 mmol/L).
3. Myocardial infarction (MI), stroke or transient ischaemic attack (TIA) within 6 months prior to informed consent.
4. Impaired hepatic or renal function, or gastric bypass surgery.
5. Treatment with glitazones, glucagon like peptide-1 (GLP-1) analogues/mimetics, antiobesity agents, or insulin within 3 months of informed consent.
6. Current treatment with systemic steroids or change in dosage of thyroid hormones.
7. Alcohol or drug abuse within 3 months of informed consent.
8. Participation in another trial with investigational drug within 2 months prior to informed consent.
9. Pre-menopausal women who are nursing, pregnant or not practicing an acceptable method of birth control.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Boehringer Ingelheim

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

1218.62.82004 Boehringer Ingelheim Investigational Site

Pucheon, , South Korea

Site Status

1218.62.82002 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1218.62.32003 Boehringer Ingelheim Investigational Site

De Pinte, , Belgium

Site Status

1218.62.32008 Boehringer Ingelheim Investigational Site

Kortenaken, , Belgium

Site Status

1218.62.32009 Boehringer Ingelheim Investigational Site

Kumtich, , Belgium

Site Status

1218.62.32005 Boehringer Ingelheim Investigational Site

Massemen-Wetteren, , Belgium

Site Status

1218.62.32004 Boehringer Ingelheim Investigational Site

Natoye, , Belgium

Site Status

1218.62.32007 Boehringer Ingelheim Investigational Site

Sint-Job-in't-Goor, , Belgium

Site Status

1218.62.32002 Boehringer Ingelheim Investigational Site

Tessenderlo, , Belgium

Site Status

1218.62.32006 Boehringer Ingelheim Investigational Site

Wilsele, , Belgium

Site Status

1218.62.11012 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Site Status

1218.62.11007 Boehringer Ingelheim Investigational Site

Burnaby, British Columbia, Canada

Site Status

1218.62.11011 Boehringer Ingelheim Investigational Site

St. John's, Newfoundland and Labrador, Canada

Site Status

1218.62.11006 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

Site Status

1218.62.11001 Boehringer Ingelheim Investigational Site

Barrie, Ontario, Canada

Site Status

1218.62.11003 Boehringer Ingelheim Investigational Site

Brampton, Ontario, Canada

Site Status

1218.62.11004 Boehringer Ingelheim Investigational Site

Markham, Ontario, Canada

Site Status

1218.62.11005 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Site Status

1218.62.11008 Boehringer Ingelheim Investigational Site

Smiths Falls, Ontario, Canada

Site Status

1218.62.11013 Boehringer Ingelheim Investigational Site

Strathroy, Ontario, Canada

Site Status

1218.62.11014 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1218.62.11010 Boehringer Ingelheim Investigational Site

Charlottetown, Prince Edward Island, Canada

Site Status

1218.62.11002 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

1218.62.11009 Boehringer Ingelheim Investigational Site

Point Claire, Quebec, Canada

Site Status

1218.62.3303C Boehringer Ingelheim Investigational Site

Bort-les-Orgues, , France

Site Status

1218.62.3306A Boehringer Ingelheim Investigational Site

Bourg Des Cptes, , France

Site Status

1218.62.3303D Boehringer Ingelheim Investigational Site

Bugeat, , France

Site Status

1218.62.3302H Boehringer Ingelheim Investigational Site

Corsept, , France

Site Status

1218.62.3308A Boehringer Ingelheim Investigational Site

Derval, , France

Site Status

1218.62.3302B Boehringer Ingelheim Investigational Site

La Chapelle-sur-Erdre, , France

Site Status

1218.62.3304A Boehringer Ingelheim Investigational Site

Levallois-Perret, , France

Site Status

1218.62.3305A Boehringer Ingelheim Investigational Site

Marseille, , France

Site Status

1218.62.3305B Boehringer Ingelheim Investigational Site

Marseille, , France

Site Status

1218.62.3305G Boehringer Ingelheim Investigational Site

Marseille, , France

Site Status

1218.62.3305H Boehringer Ingelheim Investigational Site

Marseille, , France

Site Status

1218.62.3301A Boehringer Ingelheim Investigational Site

Nantes, , France

Site Status

1218.62.3302A Boehringer Ingelheim Investigational Site

Nantes, , France

Site Status

1218.62.3304B Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1218.62.3304D Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1218.62.3305F Boehringer Ingelheim Investigational Site

Roquevaire, , France

Site Status

1218.62.3305I Boehringer Ingelheim Investigational Site

Roquevaire, , France

Site Status

1218.62.3303A Boehringer Ingelheim Investigational Site

Rosiers-d'Égletons, , France

Site Status

1218.62.3303H Boehringer Ingelheim Investigational Site

Sainte-Fortunade, , France

Site Status

1218.62.3302I Boehringer Ingelheim Investigational Site

Sautron, , France

Site Status

1218.62.3302G Boehringer Ingelheim Investigational Site

Vue, , France

Site Status

1218.62.91001 Boehringer Ingelheim Investigational Site

Bangalore, , India

Site Status

1218.62.91004 Boehringer Ingelheim Investigational Site

Bangalore, , India

Site Status

1218.62.91003 Boehringer Ingelheim Investigational Site

Hyderabad, Andra Pradesh, , India

Site Status

1218.62.91005 Boehringer Ingelheim Investigational Site

Nagpru, , India

Site Status

1218.62.91002 Boehringer Ingelheim Investigational Site

Trivandrum, , India

Site Status

1218.62.39010 Boehringer Ingelheim Investigational Site

Ancona, , Italy

Site Status

1218.62.39006 Boehringer Ingelheim Investigational Site

Catania, , Italy

Site Status

1218.62.39004 Boehringer Ingelheim Investigational Site

Genova, , Italy

Site Status

1218.62.39009 Boehringer Ingelheim Investigational Site

Gissi (CH), , Italy

Site Status

1218.62.39003 Boehringer Ingelheim Investigational Site

Palermo, , Italy

Site Status

1218.62.39001 Boehringer Ingelheim Investigational Site

Pisa, , Italy

Site Status

1218.62.39002 Boehringer Ingelheim Investigational Site

Pordenone, , Italy

Site Status

1218.62.39012 Boehringer Ingelheim Investigational Site

Ravenna, , Italy

Site Status

1218.62.39007 Boehringer Ingelheim Investigational Site

Roma, , Italy

Site Status

1218.62.39011 Boehringer Ingelheim Investigational Site

Roma, , Italy

Site Status

1218.62.60002 Boehringer Ingelheim Investigational Site

George Town, , Malaysia

Site Status

1218.62.60001 Boehringer Ingelheim Investigational Site

Kelantan Kota Bahru, , Malaysia

Site Status

1218.62.60005 Boehringer Ingelheim Investigational Site

Kuala Lumpur, , Malaysia

Site Status

1218.62.60003 Boehringer Ingelheim Investigational Site

Putrajaya, , Malaysia

Site Status

1218.62.60004 Boehringer Ingelheim Investigational Site

Seremban, , Malaysia

Site Status

1218.62.31007 Boehringer Ingelheim Investigational Site

Almere Stad, , Netherlands

Site Status

1218.62.31004 Boehringer Ingelheim Investigational Site

Breezerveld, , Netherlands

Site Status

1218.62.31005 Boehringer Ingelheim Investigational Site

Etten-Leur, , Netherlands

Site Status

1218.62.31002 Boehringer Ingelheim Investigational Site

Lieshout, , Netherlands

Site Status

1218.62.31001 Boehringer Ingelheim Investigational Site

Oude Pekela, , Netherlands

Site Status

1218.62.31008 Boehringer Ingelheim Investigational Site

Voerendaal, , Netherlands

Site Status

1218.62.31009 Boehringer Ingelheim Investigational Site

Wildervank, , Netherlands

Site Status

1218.62.31003 Boehringer Ingelheim Investigational Site

Woerden, , Netherlands

Site Status

1218.62.82005 Boehringer Ingelheim Investigational Site

Goyang, , South Korea

Site Status

1218.62.82006 Boehringer Ingelheim Investigational Site

Goyang, , South Korea

Site Status

1218.62.82003 Boehringer Ingelheim Investigational Site

Incheon, , South Korea

Site Status

1218.62.82001 Boehringer Ingelheim Investigational Site

Suwon, , South Korea

Site Status

1218.62.34003 Boehringer Ingelheim Investigational Site

Badia Del Vallés (Barcelona), , Spain

Site Status

1218.62.34002 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat (Barcelona), , Spain

Site Status

1218.62.34005 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1218.62.34006 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1218.62.34007 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1218.62.34001 Boehringer Ingelheim Investigational Site

Palma (Mallorca), , Spain

Site Status

1218.62.34008 Boehringer Ingelheim Investigational Site

Palma de Mallorca, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium Canada France India Italy Malaysia Netherlands South Korea Spain

References

Explore related publications, articles, or registry entries linked to this study.

Ross SA, Rafeiro E, Meinicke T, Toorawa R, Weber-Born S, Woerle HJ. Efficacy and safety of linagliptin 2.5 mg twice daily versus 5 mg once daily in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, placebo-controlled trial. Curr Med Res Opin. 2012 Sep;28(9):1465-74. doi: 10.1185/03007995.2012.714360. Epub 2012 Aug 13.

Reference Type DERIVED
PMID: 22816729 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009-013549-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1218.62

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Linagliptin and Metformin Versus Linagliptin in Newly Diagnosed, Untreated Type 2 Diabetes
NCT01512979 COMPLETED PHASE4
Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet
NCT01383356 COMPLETED PHASE1
Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes
NCT00601250 COMPLETED PHASE3
Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients
NCT01708902 COMPLETED PHASE3
Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes
NCT01778049 COMPLETED PHASE3
Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid
NCT00915772 COMPLETED PHASE3
Bioequivalence of a 2.5 mg Linagliptin / 850 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 850 mg Tablets in Healthy Volunteers
NCT02220647 COMPLETED PHASE1
Relative Bioavailability of Two Different Batches of a Linagliptin / Metformin Combination Tablet in Healthy Volunteers
NCT01216397 COMPLETED PHASE1
Bioequivalence of a 2.5 mg Linagliptin / 500 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 500 mg Tablets Administered Together in Healthy Volunteers
NCT02221414 COMPLETED PHASE1
BI 1356 (Linagliptin) in Combination With Metformin and a Sulphonylurea in Type 2 Diabetes
NCT00602472 COMPLETED PHASE3
Effect of Low Dose Combination of Linagliptin + Metformin to Prevent Diabetes
NCT04134650 UNKNOWN PHASE3
Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients
NCT01422876 COMPLETED PHASE3
Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets
NCT01581931 COMPLETED PHASE1
Bioequivalence of a Linagliptin / Metformin Fixed-dose Combination (FDC) Tablet Compared With Single Linagliptin and Metformin Tablets Administered Together in Healthy Volunteers
NCT02221401 COMPLETED PHASE1
Pharmacokinetics of Fixed Dose Combination (FDC) Tablets of Linagliptin /Metformin
NCT01540487 COMPLETED PHASE1
Relative Bioavailability of 2 Fixed Dose Combinations of Linagliptin/Metformin Compared With Single Tablets
NCT01845077 COMPLETED PHASE1
Effect of Linagliptin in Comparison With Glimepiride as Add on to Metformin on Postprandial Beta Cell Function, Postprandial Metabolism and Oxidative Stress in Patients With Type 2 Diabetes Mellitus
NCT01547104 UNKNOWN PHASE4
Bioavailability of Combination Tablet BI 1356/Metformin Compared With Single BI 1356 and Metformin Administered Together to Healthy Male and Female Subjects
NCT02173639 COMPLETED PHASE1
A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate
NCT00740051 COMPLETED PHASE3
Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus
NCT01826370 TERMINATED
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/1000mg) Extended Release in Healthy Subjects.
NCT02084056 COMPLETED PHASE1
Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes
NCT00622284 COMPLETED PHASE3
Dose Proportionality of Different Dose Strengths of Linagliptin Tablets After Oral Administration to Healthy Male and Female Volunteers
NCT02183480 COMPLETED PHASE1
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/750mg) Extended Release in Healthy Subjects
NCT02121509 COMPLETED PHASE1
A Study in Patients With Type 2 Diabetes
NCT01408095 WITHDRAWN PHASE2