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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02240680
Registration number
NCT02240680
Ethics application status
Date submitted
15/09/2014
Date registered
16/09/2014
Date last updated
3/07/2018
Titles & IDs
Public title
Linagliptin as Add on to Basal Insulin in the Elderly
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Scientific title
A 24 Week Randomized, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Trial of Once Daily Linagliptin, 5 Milligrams Orally, as Add on to Basal Insulin in Elderly Type 2 Diabetes Mellitus Patients With Insufficient Glycaemic Control
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Secondary ID [1]
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2014-000904-88
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Secondary ID [2]
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1218.149
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - placebo
Treatment: Drugs - linagliptin
Experimental: linagliptin 5 mg - patient to receive a tablet of linagliptin 5 mg each day
Placebo comparator: placebo - patient to receive a tablet of placebo matching linagliptin 5 mg
Treatment: Drugs: placebo
placebo matching linagliptin 5 mg
Treatment: Drugs: linagliptin
5 mg once a day
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.
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Assessment method [1]
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This outcome has measured difference between HbA1c values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any randomised study medication. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range.
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Timepoint [1]
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Baseline and Week 24
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Secondary outcome [1]
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Percentage of Patients Experiencing at Least One Hypoglycaemia Accompanied by a Prespecified Glucose Value.
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Assessment method [1]
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Hypoglycaemia accompanied by a prespecified glucose value is defined as any investigator reported hypoglycaemia (event or AE) with a reported blood glucose level of less than 54 milligram/deciLitre (3.0 millimole/Litre) or any investigator reported symptomatic hypoglycaemic AE with a reported blood glucose level of less or equal 70 milligram/deciLitre (3.9millimole/Litre) or any severe hypoglycaemic AE. Severe hypoglycaemia is an event that requires the assistance of another person to actively administer carbohydrates or glucagon because the patient is unable to take the substance on his or her own. The confidence intervals mentioned in measure of dispersion are exact 95% confidence interval by Clopper and Pearson. The percentage of patients with at least one hypoglycaemia accompanied by a glucose value less than 54mg/dL alone has also represented separately according American Diabetes Association definition of clinically significant hypoglycaemia.
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Timepoint [1]
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24 weeks
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Secondary outcome [2]
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Percentage of Patients With HbA1c<8.0%
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Assessment method [2]
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This is the percentage of patients with HbA1c on treatment \<8.0% after 24 weeks of treatment. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.
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Timepoint [2]
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24 weeks
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Secondary outcome [3]
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Percentage of Patients With HbA1c on Treatment <7.0%
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Assessment method [3]
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This is the percentage of patients with HbA1c on treatment \<7.0% after 24 weeks of treatment. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.
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Timepoint [3]
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24 weeks
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Secondary outcome [4]
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Percentage of Patients With HbA1c Lowering by at Least 0.5%.
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Assessment method [4]
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The percentage of patients who attained lowering of HbA1c by =0.5% from baseline after 24 weeks of treatment were analysed. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.
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Timepoint [4]
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24 weeks
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Secondary outcome [5]
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Change From Baseline in Fasting Plasma Glucose (FPG)
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Assessment method [5]
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This outcome has measured difference between FPG values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any randomised study medication
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Timepoint [5]
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Baseline and Week 24
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Eligibility
Key inclusion criteria
Inclusion criteria:
* Patients must sign and date an Informed Consent consistent with International Conference on Harmonisation and Good Clinical Practice guidelines and local regulations prior to any evaluation and participation in the trial.
* Male and female patients with a clinical diagnosis of Type 2 Diabetes Mellitus, at the time of Informed Consent, who are:
* 60 years of age or older at informed consent or Screen Visit,
* taking stable doses of basal or biosimilar basal insulin [strictly inclusive of: insulin neutral protamine Hagedorn and isophane insulin; Humalog Basal (a suspension of insulin lispro protamine); insulin degludec; insulin detemir; and insulin glargine] for at least 4 weeks prior to randomisation (Visit 3) with dose adjustments up to a maximum of plus or minus 20% of baseline being allowed,
* may or may not be taking metformin immediate release or extended release [if the patient is taking metformin, stable dose must be maintained for at least twelve weeks without dose adjustments prior to randomisation (Visit 3)], and
* may or may not be taking alpha-glucosidase inhibitors [acarbose, miglitol, and voglibose; if the patient is taking alpha-glucosidase inhibitors, stable dose must be maintained for at least twelve weeks without dose adjustments prior to randomisation (Visit 3)].
* Patients must have an glycosylated Haemoglobin of 7.0% (53 millimoles per mole) to 10.0% (86 millimoles per mole) at the first visit (Screen).
* Patients must have a Body Mass Index of 45 kilogram/meter squared or less at the Screen Visit.
* In the investigator's opinion, patients must be reliable, compliant, and agree to cooperate with all planned future trial evaluations as explained in detail during the informed consent process and to be able to perform them.
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Minimum age
60
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
* Impaired cognitive ability as supported by the Saint Louis University Mental Status Examination, additional assessment if necessary, and verified by the investigator at the Screen Visit.
* Depressed mood as supported by a score of 10 or more on the Patient Health Questionnaire at the Screen Visit.
* Type 1 Diabetes Mellitus as determined by past medical records and history.
* Acute coronary syndrome (non-ST Elevation Myocardial Infarction, ST Elevation Myocardial Infarction, and/or unstable angina pectoris), stroke or transient ischemic attack within 3 months prior to Screen Visit.
* Indication of liver disease determined during Screen and/or Run-In Period, defined by a serum level above 3 times the upper limit of normal in any of the following: alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase.
* Bariatric, gastric bypass, and other gastrointestinal procedures or surgeries (including all types of gastric banding, restriction, and/or LapBand) with the objective of promoting weight loss within the past two years at Screen Visit.
* Medical history of cancer (except for resected non-invasive basal or squamous cell carcinoma) and/or treatment for cancer within the last 5 years.
* Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (malaria, babesiosis, haemolytic anaemia).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/09/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
25/04/2017
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Sample size
Target
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Accrual to date
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Final
302
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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AIM Centre - Merewether
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Royal Brisbane & Women's Hospital-Endocrinology - Herston
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ECRU Maroondah - East Ringwood
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2291 - Merewether
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4029 - Herston
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3135 - East Ringwood
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Boehringer Ingelheim
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Eli Lilly and Company
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Ethics approval
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Summary
Brief summary
To investigate the efficacy, safety, and tolerability of linagliptin 5 milligrams once a day compared to placebo as as add-on therapy for 24 weeks to stable basal insulin treatment in elderly patients, 60 years of age and older, with Type 2 Diabetes Mellitus and insufficient glycaemic control.Stable background therapy of metformin and/or alpha-glucosidase inhibitors is also allowed. In addition, this trial will assess if linagliptin reduces the risk of hypoglycaemia when added to background basal insulin therapy. The treatment duration of this trial (24 weeks) will enable assessment of the clinically relevant endpoint of a decrease in glycosylated Haemoglobin, a well-accepted measurement of chronic glycaemic control.
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Trial website
https://clinicaltrials.gov/study/NCT02240680
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Trial related presentations / publications
Araki E, Unno Y, Tanaka Y, Sakamoto W, Miyamoto Y. Long-Term Efficacy and Safety of Linagliptin in a Japanese Population with Type 2 Diabetes Aged >/= 60 Years Treated with Basal Insulin: A Randomised Trial. Adv Ther. 2019 Oct;36(10):2697-2711. doi: 10.1007/s12325-019-01065-7. Epub 2019 Sep 3.
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Public notes
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Contacts
Principal investigator
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Boehringer Ingelheim
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Boehringer Ingelheim
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Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/80/NCT02240680/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/80/NCT02240680/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02240680
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