Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks, in Drug naïve or Previously Treated Type 2 Diabetic Patients With Insufficient Glycaemic Control
NCT ID: NCT01214239
Last Updated: 2016-08-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2010-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Linagliptin Add-on to Insulin Background Therapy
NCT02897349
Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes
NCT00954447
Efficacy and Safety of Linagliptin in Elderly Patients With Type 2 Diabetes
NCT01084005
Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone
NCT00996658
Randomized, Double-blind (db), Placebo-controlled 18 Week Study of Linagliptin (BI 1356) in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug
NCT00819091
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.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Linagliptin
once a day
Linagliptin
once a day
Placebo
once a day
Placebo
once a day
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
once a day
Linagliptin
once a day
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Diagnosis of type 2 diabetes prior to informed consent
3. Glycosylated haemoglobin A1 (HbA1c) at Visit 1a (Screening):
For patients undergoing wash out of previous medication: HbA1c =7.0to =9.5% For patients not undergoing wash-out of previous medication: HbA1c =7.0 to =10.0%
4. Glycosylated haemoglobin A1 (HbA1c) =7.0 to =10.0% at Visit 2 (Start of Run-in)
5. Age = 18 and \< 80 years at Visit 1a (Screening)
6. BMI (Body Mass Index) = 45 kg/m2 at Visit 1a (Screening)
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, defined by serum levels of either Alanine transaminase(SGPT), Aspartate transaminase(SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1a
3. Uncontrolled hyperglycaemia with a glucose level \>240 mg/dl (\>13.3 mmol/L) after an overnight fast during wash-out / placebo run-in and confirmed by a second measurement (not on the same day)
4. Known hypersensitivity or allergy to the investigational product or its excipients
5. Treatment with more than one antidiabetic drug within 6 weeks prior to informed consent
6. Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
7. Treatment with Glucagon-like peptide 1(GLP-1) analogues (e.g. exenatide) , Dipeptidyl-Peptidase 4(DPP-IV) inhibitor within 3 months prior to informed consent
8. Treatment with insulin within 3 months prior to informed consent
9. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent
10. Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse
11. Participation in another trial with an investigational drug within 2 months prior to informed consent
12. 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 and do not agree to submit to periodic pregnancy testing during 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.
13. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
14. Renal failure or renal impairment (serum creatinine =1.5 mg/dl as determined at Visit 1a)
15. Dehydration by clinical judgement of the investigator
16. Unstable or acute congestive heart failure
17. Acute or chronic metabolic acidosis (present in patient history)
18. Hereditary galactose intolerance
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eli Lilly and Company
INDUSTRY
Boehringer Ingelheim
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
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.
1218.66.86007 Boehringer Ingelheim Investigational Site
Beijing, , China
1218.66.86011 Boehringer Ingelheim Investigational Site
Chongqing, , China
1218.66.86008 Boehringer Ingelheim Investigational Site
Dalian, , China
1218.66.86010 Boehringer Ingelheim Investigational Site
Fuzhou, , China
1218.66.86014 Boehringer Ingelheim Investigational Site
Hangzhou, , China
1218.66.86005 Boehringer Ingelheim Investigational Site
Hefei, , China
1218.66.86006 Boehringer Ingelheim Investigational Site
Hefei, , China
1218.66.86012 Boehringer Ingelheim Investigational Site
Nanjing, , China
1218.66.86001 Boehringer Ingelheim Investigational Site
Shanghai, , China
1218.66.86002 Boehringer Ingelheim Investigational Site
Shanghai, , China
1218.66.86003 Boehringer Ingelheim Investigational Site
Shanghai, , China
1218.66.86004 Boehringer Ingelheim Investigational Site
Suzhou, , China
1218.66.86015 Boehringer Ingelheim Investigational Site
Wenzhou, , China
1218.66.86009 Boehringer Ingelheim Investigational Site
Wuhan, , China
1218.66.86013 Boehringer Ingelheim Investigational Site
Yangzhou, , China
1218.66.60002 Boehringer Ingelheim Investigational Site
Johor Bahru, , Malaysia
1218.66.60001 Boehringer Ingelheim Investigational Site
Kelantan, , Malaysia
1218.66.63001 Boehringer Ingelheim Investigational Site
Marikina City, , Philippines
1218.66.63002 Boehringer Ingelheim Investigational Site
San Juan City, , Philippines
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1218.66
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.