Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
Secondary ID [1] 0 0
2012-000905-53
Secondary ID [2] 0 0
1276.10
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16
Timepoint [1] 0 0
Baseline and 16 weeks
Secondary outcome [1] 0 0
Fasting Plasma Glucose (FPG) Change From Baseline at Week 16
Timepoint [1] 0 0
Baseline and 16 weeks

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
983
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
1276.10.61002 Boehringer Ingelheim Investigational Site - Wollongong
Recruitment hospital [2] 0 0
1276.10.61001 Boehringer Ingelheim Investigational Site - Box Hill
Recruitment postcode(s) [1] 0 0
- Wollongong
Recruitment postcode(s) [2] 0 0
- Box Hill
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maine
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Canada
State/province [20] 0 0
Alberta
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Manitoba
Country [23] 0 0
Canada
State/province [23] 0 0
New Brunswick
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec
Country [26] 0 0
Estonia
State/province [26] 0 0
Pärnu
Country [27] 0 0
Estonia
State/province [27] 0 0
Tallinn
Country [28] 0 0
Estonia
State/province [28] 0 0
Viljandi County
Country [29] 0 0
France
State/province [29] 0 0
Aire sur l'Adour
Country [30] 0 0
France
State/province [30] 0 0
Bischheim
Country [31] 0 0
France
State/province [31] 0 0
Bourg des Comptes
Country [32] 0 0
France
State/province [32] 0 0
Bourges
Country [33] 0 0
France
State/province [33] 0 0
Broglie
Country [34] 0 0
France
State/province [34] 0 0
Mont de Marsan
Country [35] 0 0
France
State/province [35] 0 0
Paris
Country [36] 0 0
France
State/province [36] 0 0
Saint Vinecnt de Tyrosse
Country [37] 0 0
France
State/province [37] 0 0
Segre
Country [38] 0 0
France
State/province [38] 0 0
Strasbourg
Country [39] 0 0
Georgia
State/province [39] 0 0
Tbilisi
Country [40] 0 0
Germany
State/province [40] 0 0
Aschaffenburg
Country [41] 0 0
Germany
State/province [41] 0 0
Berlin
Country [42] 0 0
Germany
State/province [42] 0 0
Essen
Country [43] 0 0
Germany
State/province [43] 0 0
Frankfurt
Country [44] 0 0
Germany
State/province [44] 0 0
Nürnberg
Country [45] 0 0
Germany
State/province [45] 0 0
Rehlingen-Siersburg
Country [46] 0 0
Guatemala
State/province [46] 0 0
Guatemala Ciudad
Country [47] 0 0
Guatemala
State/province [47] 0 0
Quetzaltenango Ciudad
Country [48] 0 0
Italy
State/province [48] 0 0
Arenzano (GE)
Country [49] 0 0
Italy
State/province [49] 0 0
Bologna
Country [50] 0 0
Italy
State/province [50] 0 0
Catanzaro
Country [51] 0 0
Italy
State/province [51] 0 0
Napoli
Country [52] 0 0
Italy
State/province [52] 0 0
Palermo
Country [53] 0 0
Italy
State/province [53] 0 0
Roma
Country [54] 0 0
Italy
State/province [54] 0 0
Torino
Country [55] 0 0
Latvia
State/province [55] 0 0
Daugavpils
Country [56] 0 0
Latvia
State/province [56] 0 0
Ogre
Country [57] 0 0
Latvia
State/province [57] 0 0
Riga
Country [58] 0 0
Latvia
State/province [58] 0 0
Tukums
Country [59] 0 0
Lithuania
State/province [59] 0 0
Kaunas
Country [60] 0 0
Lithuania
State/province [60] 0 0
Klaipeda
Country [61] 0 0
Lithuania
State/province [61] 0 0
Vilnius
Country [62] 0 0
Mexico
State/province [62] 0 0
Ciudad de Mexico
Country [63] 0 0
Mexico
State/province [63] 0 0
Durango
Country [64] 0 0
Mexico
State/province [64] 0 0
Pachuca
Country [65] 0 0
Mexico
State/province [65] 0 0
Tijuana
Country [66] 0 0
New Zealand
State/province [66] 0 0
Christchurch
Country [67] 0 0
New Zealand
State/province [67] 0 0
Greenlane East Auckland NZ
Country [68] 0 0
Poland
State/province [68] 0 0
Bialystok
Country [69] 0 0
Poland
State/province [69] 0 0
Gizycko
Country [70] 0 0
Poland
State/province [70] 0 0
Katowice
Country [71] 0 0
Poland
State/province [71] 0 0
Krakow
Country [72] 0 0
Poland
State/province [72] 0 0
Warszawa
Country [73] 0 0
Russian Federation
State/province [73] 0 0
Moscow
Country [74] 0 0
Russian Federation
State/province [74] 0 0
St. Petersburg
Country [75] 0 0
South Africa
State/province [75] 0 0
Paarl
Country [76] 0 0
South Africa
State/province [76] 0 0
Parow
Country [77] 0 0
South Africa
State/province [77] 0 0
Plumstead, Cape Town
Country [78] 0 0
South Africa
State/province [78] 0 0
Pretoria
Country [79] 0 0
South Africa
State/province [79] 0 0
Somerset West
Country [80] 0 0
Spain
State/province [80] 0 0
Barcelona
Country [81] 0 0
Spain
State/province [81] 0 0
L'Hospitalet de Llobregat
Country [82] 0 0
Spain
State/province [82] 0 0
Les Borges del Camp
Country [83] 0 0
Spain
State/province [83] 0 0
Sant Adria del Besos
Country [84] 0 0
Spain
State/province [84] 0 0
Vic
Country [85] 0 0
Ukraine
State/province [85] 0 0
Kharkiv
Country [86] 0 0
Ukraine
State/province [86] 0 0
Kiev
Country [87] 0 0
Ukraine
State/province [87] 0 0
Kyiv

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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