MedDataX Logo

Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients

NCT ID: NCT01708902

Last Updated: 2015-04-24

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

PHASE3

Total Enrollment

876 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-04-30

Brief Summary

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

Reduced factorial design study with 24 week randomized treatment of initial combination therapy with linagliptin and metformin in T2DM patients

Related Clinical Trials

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

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

Linagliptin and Metformin Versus Linagliptin in Newly Diagnosed, Untreated Type 2 Diabetes

NCT01512979

Diabetes Mellitus, Type 2
COMPLETED PHASE4

Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes

NCT01778049

Diabetes Mellitus, Type 2
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

Healthy
COMPLETED PHASE1

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

NCT01012037

Diabetes Mellitus, Type 2
COMPLETED PHASE2

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

FACTORIAL

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.

linagliptin2.5mg / metformin500mg BID

patient to receive a tablet containing linagliptin 2.5mg and metformin 500mg BID

Group Type EXPERIMENTAL

linagliptin 5mg

Intervention Type DRUG

linagliptin 5mg once daily

Metformin 500mg

Intervention Type DRUG

Metformin 500mg BID

linagliptin2.5mg / metformin1000mg BID

patient to receive a tablet containing linagliptin 2.5mg and metformin 1000mg BID

Group Type EXPERIMENTAL

linagliptin 5mg

Intervention Type DRUG

linagliptin 5mg once daily

Metformin 1000mg

Intervention Type DRUG

Metformin 1000mg BID

metformin 500mg BID

patient to receive a tablet containing metformin 500mg BID

Group Type ACTIVE_COMPARATOR

linagliptin2.5mg/metformin500mg

Intervention Type DRUG

linagliptin2.5mg/metformin500mg BID

metformin 1000mg BID

patient to receive a tablet containing metformin 1000mg BID

Group Type ACTIVE_COMPARATOR

linagliptin2.5mg/metformin1000mg

Intervention Type DRUG

linagliptin2.5mg/metformin1000mg BID

linagliptin 5 mg QD

patient to receive a tablet containing linagliptin 5mg once daily

Group Type ACTIVE_COMPARATOR

linagliptin2.5mg/metformin1000mg

Intervention Type DRUG

linagliptin2.5mg/metformin1000mg BID

linagliptin2.5mg/metformin500mg

Intervention Type DRUG

linagliptin2.5mg/metformin500mg BID

Interventions

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

linagliptin2.5mg/metformin1000mg

linagliptin2.5mg/metformin1000mg BID

Intervention Type DRUG

linagliptin2.5mg/metformin1000mg

linagliptin2.5mg/metformin1000mg BID

Intervention Type DRUG

linagliptin 5mg

linagliptin 5mg once daily

Intervention Type DRUG

Metformin 500mg

Metformin 500mg BID

Intervention Type DRUG

linagliptin2.5mg/metformin500mg

linagliptin2.5mg/metformin500mg BID

Intervention Type DRUG

linagliptin2.5mg/metformin500mg

linagliptin2.5mg/metformin500mg BID

Intervention Type DRUG

linagliptin 5mg

linagliptin 5mg once daily

Intervention Type DRUG

Metformin 1000mg

Metformin 1000mg BID

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(T2DM) prior to informed consent
2. Male and female patients on diet and exercise regimen who are drug-naïve
3. Glycosylated haemoglobin A1c (HbA1c) at V1a \>/=7.5 %\<11% for main group and HbA1c \>/= 11.0 % for the additional parallel group
4. Age \>/= 18 and \</= 80 years at Visit 1a (Screening)
5. Body Mass Index(BMI)\</ = 40 kg/m2 at Visit 1a (Screening)
6. Signed and dated written informed consent by date of Visit 1a in accordance with good clinical practice(GCP) and local legislation

Exclusion Criteria

1. Uncontrolled hyperglycaemia required for rescue medication during placebo run-in phase
2. In main group, the patients with investigational medicinal product(IMP) compliance \< 80 % or \>120 % during 2 weeks placebo run in period
3. Acute coronary syndrome stroke or Transient ischaemic attack (TIA) within 3 months prior to randomisation
4. Impaired hepatic function, defined by serum levels of either Alanine aminotransferase(ALT) ,Aspartate aminotransferase(AST), or alkaline phosphatase (AP) above 3 x upper limit of normal (ULN) ,or total bilirubin above 1.5 x ULN as determined at Visit 1a
5. Known hypersensitivity or allergy to linagliptin or its excipients or metformin or placebo
6. Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening
7. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake in the opinion of the investigator.
8. Concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form or during the trial.
9. Pre-menopausal women (last menstruation \</= 1 year prior to 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
10. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
11. Renal failure or renal impairment at Visit 1a (screening) with an Estimated Glomerular Filtration Rate(eGFR) \< 60 ml/min
12. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
13. Dehydration by clinical judgement of the investigator
14. Clinical detected unstable or acute congestive heart failure
15. Acute or chronic metabolic acidosis (present in patient history)
16. Hereditary galactose intolerance
17. Known history of pancreatitis and chronic pancreatitis
18. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within last 5 years.
19. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial at the discretion of investigator
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.

Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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

Responsibility Role SPONSOR

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.

1288.18.86001 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1288.18.86002 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1288.18.86003 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1288.18.86004 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1288.18.86046 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1288.18.86019 Boehringer Ingelheim Investigational Site

Changchun, , China

Site Status

1288.18.86020 Boehringer Ingelheim Investigational Site

Changchun, , China

Site Status

1288.18.86028 Boehringer Ingelheim Investigational Site

Changsha, , China

Site Status

1288.18.86029 Boehringer Ingelheim Investigational Site

Changsha, , China

Site Status

1288.18.86050 Boehringer Ingelheim Investigational Site

Changsha, , China

Site Status

1288.18.86045 Boehringer Ingelheim Investigational Site

Chengdu, , China

Site Status

1288.18.86042 Boehringer Ingelheim Investigational Site

Chongqing, , China

Site Status

1288.18.86023 Boehringer Ingelheim Investigational Site

Dalian, , China

Site Status

1288.18.86009 Boehringer Ingelheim Investigational Site

Guangzhou, , China

Site Status

1288.18.86010 Boehringer Ingelheim Investigational Site

Guangzhou, , China

Site Status

1288.18.86012 Boehringer Ingelheim Investigational Site

Guangzhou, , China

Site Status

1288.18.86047 Boehringer Ingelheim Investigational Site

Haerbin, , China

Site Status

1288.18.86032 Boehringer Ingelheim Investigational Site

Hefei, , China

Site Status

1288.18.86016 Boehringer Ingelheim Investigational Site

Hengshui, , China

Site Status

1288.18.86017 Boehringer Ingelheim Investigational Site

Jinan, , China

Site Status

1288.18.86026 Boehringer Ingelheim Investigational Site

Lanzhou, , China

Site Status

1288.18.86039 Boehringer Ingelheim Investigational Site

Nanchang, , China

Site Status

1288.18.86035 Boehringer Ingelheim Investigational Site

Nanjing, , China

Site Status

1288.18.86036 Boehringer Ingelheim Investigational Site

Nanjing, , China

Site Status

1288.18.86034 Boehringer Ingelheim Investigational Site

Nanning, , China

Site Status

1288.18.86006 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1288.18.86007 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1288.18.86008 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1288.18.86013 Boehringer Ingelheim Investigational Site

Shantou, , China

Site Status

1288.18.86022 Boehringer Ingelheim Investigational Site

Shenyang, , China

Site Status

1288.18.86014 Boehringer Ingelheim Investigational Site

Shijiazhuang, , China

Site Status

1288.18.86015 Boehringer Ingelheim Investigational Site

Shijiazhuang, , China

Site Status

1288.18.86038 Boehringer Ingelheim Investigational Site

Suzhou, , China

Site Status

1288.18.86049 Boehringer Ingelheim Investigational Site

Wuhan, , China

Site Status

1288.18.86033 Boehringer Ingelheim Investigational Site

Wuhu, , China

Site Status

1288.18.86024 Boehringer Ingelheim Investigational Site

Xi'an, , China

Site Status

1288.18.86025 Boehringer Ingelheim Investigational Site

Xi'an, , China

Site Status

1288.18.86030 Boehringer Ingelheim Investigational Site

Yueyang, , China

Site Status

1288.18.60004 Boehringer Ingelheim Investigational Site

Kelantan, , Malaysia

Site Status

1288.18.60003 Boehringer Ingelheim Investigational Site

Kuala Selangor, , Malaysia

Site Status

1288.18.60002 Boehringer Ingelheim Investigational Site

Malacca, , Malaysia

Site Status

1288.18.60005 Boehringer Ingelheim Investigational Site

Negeri Sembilan, , Malaysia

Site Status

1288.18.60007 Boehringer Ingelheim Investigational Site

Negeri Sembilan, , Malaysia

Site Status

1288.18.60001 Boehringer Ingelheim Investigational Site

Perak, , Malaysia

Site Status

1288.18.60006 Boehringer Ingelheim Investigational Site

Perak, , Malaysia

Site Status

1288.18.60008 Boehringer Ingelheim Investigational Site

Putrajaya, , Malaysia

Site Status

1288.18.63007 Boehringer Ingelheim Investigational Site

Cebu, , Philippines

Site Status

1288.18.63003 Boehringer Ingelheim Investigational Site

Cebu City, , Philippines

Site Status

1288.18.63002 Boehringer Ingelheim Investigational Site

Makati City, , Philippines

Site Status

1288.18.63001 Boehringer Ingelheim Investigational Site

Manila, , Philippines

Site Status

1288.18.63008 Boehringer Ingelheim Investigational Site

Quezon City, , Philippines

Site Status

1288.18.63006 Boehringer Ingelheim Investigational Site

Surigao City, , Philippines

Site Status

1288.18.63005 Boehringer Ingelheim Investigational Site

Tagum, , Philippines

Site Status

1288.18.84003 Boehringer Ingelheim Investigational Site

Hanoi, , Vietnam

Site Status

1288.18.84001 Boehringer Ingelheim Investigational Site

Ho Chi Minh City, , Vietnam

Site Status

1288.18.84002 Boehringer Ingelheim Investigational Site

Ho Chi Minh City, , Vietnam

Site Status

Countries

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

China Malaysia Philippines Vietnam

References

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

Lv Q, Shen J, Miao L, Ye B, Schepers C, Plat A, Shi Y. Early Combination Therapy with Linagliptin and Metformin in People with Type 2 Diabetes Improves Glycemic Control to HbA1c </= 6.5% without Increasing Hypoglycemia: Pooled Analysis of Two Randomized Clinical Trials. Diabetes Ther. 2020 Jun;11(6):1317-1330. doi: 10.1007/s13300-020-00819-9. Epub 2020 Apr 23.

Reference Type DERIVED
PMID: 32328953 (View on PubMed)

Other Identifiers

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

1288.18

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

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
Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design
NCT00798161 COMPLETED PHASE3
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 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
Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes
NCT00309608 COMPLETED PHASE2
Pharmacokinetics of Fixed Dose Combination (FDC) Tablets of Linagliptin /Metformin
NCT01540487 COMPLETED PHASE1
A Study in Patients With Type 2 Diabetes
NCT01408095 WITHDRAWN PHASE2
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
Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients
NCT00328172 COMPLETED PHASE2
Relative Bioavailability of 2 Fixed Dose Combinations of Linagliptin/Metformin Compared With Single Tablets
NCT01845077 COMPLETED PHASE1
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/1000mg) Extended Release in Healthy Subjects.
NCT02084056 COMPLETED PHASE1
Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet
NCT01383356 COMPLETED PHASE1
Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes
NCT01719003 COMPLETED PHASE3
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Linagliptin/Metformin Extended Release Compared With Single Tablets
NCT02821910 COMPLETED PHASE1
Relative Bioavailability of Two Different Batches of a Linagliptin / Metformin Combination Tablet in Healthy Volunteers
NCT01216397 COMPLETED PHASE1
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (5mg/1000mg) Extended Release in Healthy Subjects
NCT02084082 COMPLETED PHASE1
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/750mg) Extended Release in Healthy Subjects
NCT02121509 COMPLETED PHASE1
Effect of Low Dose Combination of Linagliptin + Metformin to Prevent Diabetes
NCT04134650 UNKNOWN PHASE3
Relative Bioavailability of a Linagliptin+Metformin Fixed Dose Combination Tablet Administered With and Without Food to Healthy Male and Female Subjects
NCT02223026 COMPLETED PHASE1
Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets
NCT01581931 COMPLETED PHASE1
This Study in Healthy People Tests Whether Taking a Low Strength of Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills
NCT03629054 COMPLETED PHASE1
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
A Comparison of SLx-4090 in Combination With Metformin Versus Metformin Therapy Alone in Patients With Type 2 Diabetes
NCT00871936 COMPLETED PHASE2
Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes
NCT00601250 COMPLETED PHASE3
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