Clinical trial NCT01177813: Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes
Official title: A Phase III Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 10773 and Sitagliptin Administered Orally Over 24 Weeks, in Drug naïve Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Diet and Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2010-08-09
Enrollment: 986
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the efficacy, safety and tolerability of BI 10773 compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 10773 when given for 24 weeks in patients with T2DM with very poor glycaemic control.


Eligibility criteria: Inclusion criteria:

1. Diagnosis of type 2 diabetes mellitus prior to informed consent;
2. Male and female patients on diet and exercise regimen who are drug-naïve;
3. HbA1c \>= 7.0% and \<= 10.0% at Visit 1 (screening) for randomised treatment; HbA1c \> 10.0% at visit 1 (screening) for the open-label BI 10773 arm;
4. Age \>= 20 (Japan); Age \>= 18 (countries other than Japan);
5. BMI \<= 45 kg/m2 at Visit 1 (screening);
6. Signed and dated written informed consent by date of Visit 1

Exclusion criteria:

1. Uncontrolled hyperglycaemia;
2. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent;
3. Indication of liver disease, either ALT, AST, or alkaline phosphatase above 3 x ULN;
4. Impaired renal function (eGFR\<50 ml/min);
5. Bariatric surgery within the past two years or other GI surgeries;
6. Medical history of cancer;
7. Contraindications to sitagliptin;
8. Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell;
9. Treatment with any anti-diabetes drug within 12 weeks prior to randomisation;
10. Treatment with anti-obesity drugs or any other treatment leading to unstable body weight;
11. Current treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM;
12. Pre-menopausal women who are nursing or pregnant or are of child-bearing potential and not practicing an acceptable method of birth control;
13. Alcohol or drug abuse;
14. Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial;
15. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial

Primary outcomes:
measure: Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks
timeFrame: Baseline and day 169
Secondary outcomes:
measure: Change From Baseline to Week 24 in Body Weight
timeFrame: Baseline and day 169
measure: Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP)
timeFrame: Baseline and week 24
Other outcomes:
measure: Confirmed Hypoglycaemic Adverse Events
timeFrame: From first drug intake until 7 days after last medication intake, up to 219 days
Locations:
city: Mesa
country: United States
facility: 1245.20.10124 Boehringer Ingelheim Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: 1245.20.10108 Boehringer Ingelheim Investigational Site
state: Arizona
city: Hot Springs
country: United States
facility: 1245.20.10150 Boehringer Ingelheim Investigational Site
state: Arkansas
city: Chino
country: United States
facility: 1245.20.10154 Boehringer Ingelheim Investigational Site
state: California
city: Santa Ana
country: United States
facility: 1245.20.10009 Boehringer Ingelheim Investigational Site
state: California
city: West Hills
country: United States
facility: 1245.20.10131 Boehringer Ingelheim Investigational Site
state: California
city: Northglenn
country: United States
facility: 1245.20.10038 Boehringer Ingelheim Investigational Site
state: Colorado
city: Clearwater
country: United States
facility: 1245.20.10137 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 1245.20.10006 Boehringer Ingelheim Investigational Site
state: Florida
city: Plantation
country: United States
facility: 1245.20.10085 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 1245.20.10078 Boehringer Ingelheim Investigational Site
state: Florida
city: Decatur
country: United States
facility: 1245.20.10080 Boehringer Ingelheim Investigational Site
state: Georgia
city: Avon
country: United States
facility: 1245.20.10128 Boehringer Ingelheim Investigational Site
state: Indiana
city: Fishers
country: United States
facility: 1245.20.10060 Boehringer Ingelheim Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: 1245.20.10065 Boehringer Ingelheim Investigational Site
state: Indiana
city: Arkansas City
country: United States
facility: 1245.20.10117 Boehringer Ingelheim Investigational Site
state: Kansas
city: Wichita
country: United States
facility: 1245.20.10039 Boehringer Ingelheim Investigational Site
state: Kansas
city: Louisville
country: United States
facility: 1245.20.10146 Boehringer Ingelheim Investigational Site
state: Kentucky
city: Watertown
country: United States
facility: 1245.20.10144 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Brick
country: United States
facility: 1245.20.10115 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Carlisle
country: United States
facility: 1245.20.10129 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: 1245.20.10045 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: 1245.20.10119 Boehringer Ingelheim Investigational Site
state: Ohio
city: Gallipolis
country: United States
facility: 1245.20.10130 Boehringer Ingelheim Investigational Site
state: Ohio
city: Houston
country: United States
facility: 1245.20.10089 Boehringer Ingelheim Investigational Site
state: Texas
city: Hurst
country: United States
facility: 1245.20.10151 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1245.20.10155 Boehringer Ingelheim Investigational Site
state: Texas
city: Bruxelles
country: Belgium
facility: 1245.20.32008 Boehringer Ingelheim Investigational Site
city: Bruxelles
country: Belgium
facility: 1245.20.32011 Boehringer Ingelheim Investigational Site
city: Bruxelles
country: Belgium
facility: 1245.20.32023 Boehringer Ingelheim Investigational Site
city: De Pinte
country: Belgium
facility: 1245.20.32003 Boehringer Ingelheim Investigational Site
city: Deurne
country: Belgium
facility: 1245.20.32015 Boehringer Ingelheim Investigational Site
city: Deurne
country: Belgium
facility: 1245.20.32016 Boehringer Ingelheim Investigational Site
city: Gozée
country: Belgium
facility: 1245.20.32025 Boehringer Ingelheim Investigational Site
city: Landen
country: Belgium
facility: 1245.20.32022 Boehringer Ingelheim Investigational Site
city: Leopoldsburg
country: Belgium
facility: 1245.20.32019 Boehringer Ingelheim Investigational Site
city: Linkebeek
country: Belgium
facility: 1245.20.32024 Boehringer Ingelheim Investigational Site
city: Mouscron
country: Belgium
facility: 1245.20.32021 Boehringer Ingelheim Investigational Site
city: Retie
country: Belgium
facility: 1245.20.32027 Boehringer Ingelheim Investigational Site
city: Sint-Gillis-Waas
country: Belgium
facility: 1245.20.32020 Boehringer Ingelheim Investigational Site
city: Tielt
country: Belgium
facility: 1245.20.32018 Boehringer Ingelheim Investigational Site
city: Tremelo
country: Belgium
facility: 1245.20.32026 Boehringer Ingelheim Investigational Site
city: Chilliwack
country: Canada
facility: 1245.20.20011 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: 1245.20.20018 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: 1245.20.20015 Boehringer Ingelheim Investigational Site
state: Manitoba
city: Moncton
country: Canada
facility: 1245.20.20012 Boehringer Ingelheim Investigational Site
state: New Brunswick
city: Mount Pearl
country: Canada
facility: 1245.20.20016 Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: 1245.20.20008 Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: Barrie
country: Canada
facility: 1245.20.20001 Boehringer Ingelheim Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: 1245.20.20019 Boehringer Ingelheim Investigational Site
state: Ontario
city: London
country: Canada
facility: 1245.20.20010 Boehringer Ingelheim Investigational Site
state: Ontario
city: London
country: Canada
facility: 1245.20.20017 Boehringer Ingelheim Investigational Site
state: Ontario
city: Markham
country: Canada
facility: 1245.20.20003 Boehringer Ingelheim Investigational Site
state: Ontario
city: Newmarket
country: Canada
facility: 1245.20.20009 Boehringer Ingelheim Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: 1245.20.20013 Boehringer Ingelheim Investigational Site
state: Ontario
city: Strathroy
country: Canada
facility: 1245.20.20005 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1245.20.20002 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1245.20.20006 Boehringer Ingelheim Investigational Site
state: Ontario
city: Charlottetown
country: Canada
facility: 1245.20.20014 Boehringer Ingelheim Investigational Site
state: Prince Edward Island
city: Montague
country: Canada
facility: 1245.20.20007 Boehringer Ingelheim Investigational Site
state: Prince Edward Island
city: Trois Rivieres
country: Canada
facility: 1245.20.20021 Boehringer Ingelheim Investigational Site
state: Quebec
city: Beijing
country: China
facility: 1245.20.86007 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 1245.20.86008 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 1245.20.86001 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 1245.20.86002 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 1245.20.86003 Boehringer Ingelheim Investigational Site
city: Guiyang
country: China
facility: 1245.20.86012 Boehringer Ingelheim Investigational Site
city: Hangzhou
country: China
facility: 1245.20.86020 Boehringer Ingelheim Investigational Site
city: Jinan
country: China
facility: 1245.20.86049 Boehringer Ingelheim Investigational Site
city: Jingzhou
country: China
facility: 1245.20.86018 Boehringer Ingelheim Investigational Site
city: Nanchang
country: China
facility: 1245.20.86019 Boehringer Ingelheim Investigational Site
city: Nanjing
country: China
facility: 1245.20.86010 Boehringer Ingelheim Investigational Site
city: Nanjing
country: China
facility: 1245.20.86043 Boehringer Ingelheim Investigational Site
city: QingDao
country: China
facility: 1245.20.86016 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1245.20.86004 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1245.20.86005 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1245.20.86006 Boehringer Ingelheim Investigational Site
city: Shenyang
country: China
facility: 1245.20.86057 Boehringer Ingelheim Investigational Site
city: Shiyan
country: China
facility: 1245.20.86017 Boehringer Ingelheim Investigational Site
city: Suzhou
country: China
facility: 1245.20.86013 Boehringer Ingelheim Investigational Site
city: Taiyuan
country: China
facility: 1245.20.86015 Boehringer Ingelheim Investigational Site
city: Wuhan
country: China
facility: 1245.20.86009 Boehringer Ingelheim Investigational Site
city: Xi'An
country: China
facility: 1245.20.86011 Boehringer Ingelheim Investigational Site
city: Xiamen
country: China
facility: 1245.20.86014 Boehringer Ingelheim Investigational Site
city: Dresden
country: Germany
facility: 1245.20.49013 Boehringer Ingelheim Investigational Site
city: Düsseldorf
country: Germany
facility: 1245.20.49016 Boehringer Ingelheim Investigational Site
city: Frankfurt
country: Germany
facility: 1245.20.49015 Boehringer Ingelheim Investigational Site
city: Haag
country: Germany
facility: 1245.20.49019 Boehringer Ingelheim Investigational Site
city: Hohenmölsen
country: Germany
facility: 1245.20.49020 Boehringer Ingelheim Investigational Site
city: Köthen
country: Germany
facility: 1245.20.49014 Boehringer Ingelheim Investigational Site
city: Neuwied
country: Germany
facility: 1245.20.49002 Boehringer Ingelheim Investigational Site
city: Nürnberg
country: Germany
facility: 1245.20.49008 Boehringer Ingelheim Investigational Site
city: Schauenburg
country: Germany
facility: 1245.20.49022 Boehringer Ingelheim Investigational Site
city: St. Ingbert/Oberwürzbach
country: Germany
facility: 1245.20.49017 Boehringer Ingelheim Investigational Site
city: Unterschneidheim
country: Germany
facility: 1245.20.49003 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1245.20.91005 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1245.20.91006 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1245.20.91008 Boehringer Ingelheim Investigational Site
city: Belgaum
country: India
facility: 1245.20.91003 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 1245.20.91004 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 1245.20.91009 Boehringer Ingelheim Investigational Site
city: Mumbai, Maharastra
country: India
facility: 1245.20.91007 Boehringer Ingelheim Investigational Site
city: Mumbai
country: India
facility: 1245.20.91002 Boehringer Ingelheim Investigational Site
city: Nagpur
country: India
facility: 1245.20.91010 Boehringer Ingelheim Investigational Site
city: Tamil Nadu
country: India
facility: 1245.20.91001 Boehringer Ingelheim Investigational Site
city: Co. Cork
country: Ireland
facility: 1245.20.35302 Boehringer Ingelheim Investigational Site
city: Co. Galway
country: Ireland
facility: 1245.20.35305 Boehringer Ingelheim Investigational Site
city: Co. Wexford
country: Ireland
facility: 1245.20.35303 Boehringer Ingelheim Investigational Site
city: Offaly
country: Ireland
facility: 1245.20.35304 Boehringer Ingelheim Investigational Site
city: Wexford
country: Ireland
facility: 1245.20.35306 Boehringer Ingelheim Investigational Site
city: Chiyoda-ku, Tokyo
country: Japan
facility: 1245.20.81007 Boehringer Ingelheim Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: 1245.20.81001 Boehringer Ingelheim Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: 1245.20.81002 Boehringer Ingelheim Investigational Site
city: Ebetsu, Hokkaido
country: Japan
facility: 1245.20.81005 Boehringer Ingelheim Investigational Site
city: Kamakura, Kanagawa
country: Japan
facility: 1245.20.81004 Boehringer Ingelheim Investigational Site
city: Minato-ku, Tokyo
country: Japan
facility: 1245.20.81003 Boehringer Ingelheim Investigational Site
city: Shinjuku-ku, Tokyo
country: Japan
facility: 1245.20.81006 Boehringer Ingelheim Investigational Site
city: Shinjuku-ku, Tokyo
country: Japan
facility: 1245.20.81008 Boehringer Ingelheim Investigational Site
city: Suita, Osaka
country: Japan
facility: 1245.20.81009 Boehringer Ingelheim Investigational Site
city: Ube, Yamaguchi
country: Japan
facility: 1245.20.81010 Boehringer Ingelheim Investigational Site
city: Urasoe, Okinawa
country: Japan
facility: 1245.20.81012 Boehringer Ingelheim Investigational Site
city: Urasoe, Okinawa
country: Japan
facility: 1245.20.81013 Boehringer Ingelheim Investigational Site
city: Lugano
country: Switzerland
facility: 1245.20.41004 Boehringer Ingelheim Investigational Site
city: Rorschach
country: Switzerland
facility: 1245.20.41003 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.
citation: Cherney D, Lund SS, Perkins BA, Groop PH, Cooper ME, Kaspers S, Pfarr E, Woerle HJ, von Eynatten M. The effect of sodium glucose cotransporter 2 inhibition with empagliflozin on microalbuminuria and macroalbuminuria in patients with type 2 diabetes. Diabetologia. 2016 Sep;59(9):1860-70. doi: 10.1007/s00125-016-4008-2. Epub 2016 Jun 17.
citation: Roden M, Weng J, Eilbracht J, Delafont B, Kim G, Woerle HJ, Broedl UC; EMPA-REG MONO trial investigators. Empagliflozin monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2013 Nov;1(3):208-19. doi: 10.1016/S2213-8587(13)70084-6. Epub 2013 Sep 9.