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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01649297
Registration number
NCT01649297
Ethics application status
Date submitted
23/07/2012
Date registered
25/07/2012
Date last updated
23/07/2015
Titles & IDs
Public title
A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy
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Scientific title
A Randomised, Double Blind, Placebo Controlled, Parallel Group Efficacy and Safety Study of Oral Administration of Empagliflozin Twice Daily Versus Once Daily in Two Different Daily Doses Over 16 Weeks as add-on Therapy to a Twice Daily Dosing Regimen of Metformin in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control
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Secondary ID [1]
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2012-000905-53
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Secondary ID [2]
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1276.10
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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 - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - empagliflozin (low dose qd)
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Empagliflozin (high dose qd)
Treatment: Drugs - empagliflozin (high dose bid)
Treatment: Drugs - Placebo
Treatment: Drugs - empagliflozin (low dose bid)
Experimental: empagliflozin (high dose qd) - Patients receive Empagliflozin high dose once daily
Experimental: empagliflozin (high dose bid) - Patients receive Empagliflozin high dose split twice daily
Experimental: empagliflozin (low dose qd) - Patients receive Empagliflozin low dose once daily
Experimental: empagliflozin (low dose bid) - Patients receive Empagliflozin low dose split twice daily
Placebo comparator: Placebo - Patients receive placebo matching Empagliflozin
Treatment: Drugs: Placebo
Patients receive placebo matching empagliflozin (low dose qd)
Treatment: Drugs: Placebo
Patients receive placebo matching empagliflozin (low dose bid)
Treatment: Drugs: Placebo
Patients receive placebo matching Empagliflozin (high dose qd)
Treatment: Drugs: Placebo
Patients receive placebo matching Empagliflozin (high dose qd)
Treatment: Drugs: Placebo
Patients receive placebo matching Empagliflozin (high dose qd)
Treatment: Drugs: empagliflozin (low dose qd)
Patients receive Empagliflozin low dose once daily
Treatment: Drugs: Placebo
Patients receive placebo matching empagliflozin (low dose qd)
Treatment: Drugs: Placebo
Patients receive placebo matching empagliflozin (low dose bid)
Treatment: Drugs: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)
Treatment: Drugs: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)
Treatment: Drugs: Placebo
Patients receive placebo matching empagliflozin (low dose qd)
Treatment: Drugs: Placebo
Patients receive placebo matching empagliflozin (low dose bid)
Treatment: Drugs: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)
Treatment: Drugs: Placebo
Patients receive placebo matching empagliflozin (low dose qd)
Treatment: Drugs: Placebo
Patients receive placebo matching empagliflozin (low dose bid)
Treatment: Drugs: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)
Treatment: Drugs: Empagliflozin (high dose qd)
Patients receive Empagliflozin high dose once daily
Treatment: Drugs: empagliflozin (high dose bid)
Patients receive Empagliflozin high dose split twice daily
Treatment: Drugs: Placebo
Patients receive placebo matching Empagliflozin (high dose qd)
Treatment: Drugs: empagliflozin (low dose bid)
Patients receive Empagliflozin low dose split twice daily
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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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HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16
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Assessment method [1]
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Change from baseline in HbA1c (%) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.
Means provided are the adjusted means.
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Timepoint [1]
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Baseline and 16 weeks
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Secondary outcome [1]
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Fasting Plasma Glucose (FPG) Change From Baseline at Week 16
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Assessment method [1]
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Change from baseline in FPG (mg/dL) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.
Means provided are the adjusted means.
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Timepoint [1]
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Baseline and 16 weeks
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Eligibility
Key inclusion criteria
Inclusion criteria:
1. confirmed diagnosis of T2DM
2. Glycated hemoglobin (HbA1c) >=7.0 and <=10/0% at Visit 1
3. Metformin therapy (at least 1500 mg/day, BID)
4. age>=18 at Visit 1
5. body mass index <=45 kg/m2
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Minimum age
18
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:
1. estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula) screening and/or run-in
2. a confirmed glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in
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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?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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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
1/10/2012
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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
1/12/2013
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Sample size
Target
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Accrual to date
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Final
983
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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1276.10.61002 Boehringer Ingelheim Investigational Site - Wollongong
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Recruitment hospital [2]
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1276.10.61001 Boehringer Ingelheim Investigational Site - Box Hill
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- Wollongong
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Recruitment postcode(s) [2]
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- Box Hill
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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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Name [1]
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Eli Lilly and Company
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Ethics approval
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Summary
Brief summary
The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.
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Trial website
https://clinicaltrials.gov/study/NCT01649297
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Trial related presentations / publications
Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
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Public notes
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Contacts
Principal investigator
Name
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Boehringer Ingelheim
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Boehringer Ingelheim
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01649297
Download to PDF