Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes

NCT01177813 | Completed Phase 3 Results

• 2 other identifiers: 1245.202009-016243-20
• Study Type: interventional
• Target: 986
• Locations: 9 countries
• Sites: 124

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks

  The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.

  Baseline and day 169

Secondary Outcomes (2)

• Change From Baseline to Week 24 in Body Weight

  Baseline and day 169

• Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP)

  Baseline and week 24

Other Outcomes (1)

• Confirmed Hypoglycaemic Adverse Events

  From first drug intake until 7 days after last medication intake, up to 219 days

Study Arms (5)

BI 10773 low dose

EXPERIMENTAL

Patients receive BI 10773 low dose tablets once daily

Drug: Placebo identical to BI10773 high dose; Drug: BI 10773; Drug: Placebo identical to Sitagliptin 100mg

BI 10773 high dose

EXPERIMENTAL

Patients receive BI 10773 high dose tablets once daily

Drug: Placebo identical to BI10773 low dose; Drug: BI10773; Drug: Placebo identical to Sitagliptin 100mg

Placebo

PLACEBO COMPARATOR

Patients receive tablets identical to those containing BI 10773 low dose and high dose and to Sitagliptin

Drug: Placebo identical to BI10773 low dose; Drug: Placebo identical to Sitagliptin 100mg; Drug: Placebo identical to BI10773 high dose

Sitagliptin 100 mg

ACTIVE COMPARATOR

Patients receive Sitagliptin 100 mg tablets once daily

Drug: Placebo identical to BI10773 high dose; Drug: Sitagliptin; Drug: Placebo identical to BI10773 low dose

BI 10773 high dose open label

EXPERIMENTAL

Patients receive BI 10773 high dose tablets open label once daily

Drug: BI 10773 open label

Interventions

BI 10773 DRUG

BI 10773 low dose tablet once daily

BI 10773 low dose

BI 10773 open label DRUG

Patients receive BI 10773 high dose tablets open label once daily

BI 10773 high dose open label

Placebo identical to BI10773 low dose DRUG

placebo tablets once daily

BI 10773 high dose

Placebo identical to Sitagliptin 100mg DRUG

placebo tablets once daily

Placebo

BI10773 DRUG

BI 10773 high dose tablets once daily

BI 10773 high dose

Sitagliptin DRUG

Sitagliptin tablets 100 mg once daily

Sitagliptin 100 mg

Placebo identical to BI10773 high dose DRUG

placebo tablets once daily

BI 10773 low dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of type 2 diabetes mellitus prior to informed consent;
• Male and female patients on diet and exercise regimen who are drug-naïve;
• 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;
• Age \>= 20 (Japan); Age \>= 18 (countries other than Japan);
• BMI \<= 45 kg/m2 at Visit 1 (screening);
• Signed and dated written informed consent by date of Visit 1

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Eli Lilly and Company: collaborator

Study Sites (124)

1245.20.10124 Boehringer Ingelheim Investigational Site

Mesa, Arizona, United States

Location

1245.20.10108 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

1245.20.10150 Boehringer Ingelheim Investigational Site

Hot Springs, Arkansas, United States

Location

1245.20.10154 Boehringer Ingelheim Investigational Site

Chino, California, United States

Location

1245.20.10009 Boehringer Ingelheim Investigational Site

Santa Ana, California, United States

Location

1245.20.10131 Boehringer Ingelheim Investigational Site

West Hills, California, United States

Location

1245.20.10038 Boehringer Ingelheim Investigational Site

Northglenn, Colorado, United States

Location

1245.20.10137 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Location

1245.20.10006 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1245.20.10085 Boehringer Ingelheim Investigational Site

Plantation, Florida, United States

Location

1245.20.10078 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

1245.20.10080 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

Location

1245.20.10128 Boehringer Ingelheim Investigational Site

Avon, Indiana, United States

Location

1245.20.10060 Boehringer Ingelheim Investigational Site

Fishers, Indiana, United States

Location

1245.20.10065 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Location

1245.20.10117 Boehringer Ingelheim Investigational Site

Arkansas City, Kansas, United States

Location

1245.20.10039 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

Location

1245.20.10146 Boehringer Ingelheim Investigational Site

Louisville, Kentucky, United States

Location

1245.20.10144 Boehringer Ingelheim Investigational Site

Watertown, Massachusetts, United States

Location

1245.20.10115 Boehringer Ingelheim Investigational Site

Brick, New Jersey, United States

Location

1245.20.10129 Boehringer Ingelheim Investigational Site

Carlisle, Ohio, United States

Location

1245.20.10045 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

1245.20.10119 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

1245.20.10130 Boehringer Ingelheim Investigational Site

Gallipolis, Ohio, United States

Location

1245.20.10089 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1245.20.10151 Boehringer Ingelheim Investigational Site

Hurst, Texas, United States

Location

1245.20.10155 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1245.20.32008 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1245.20.32011 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1245.20.32023 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1245.20.32003 Boehringer Ingelheim Investigational Site

De Pinte, Belgium

Location

1245.20.32015 Boehringer Ingelheim Investigational Site

Deurne, Belgium

Location

1245.20.32016 Boehringer Ingelheim Investigational Site

Deurne, Belgium

Location

1245.20.32025 Boehringer Ingelheim Investigational Site

Gozée, Belgium

Location

1245.20.32022 Boehringer Ingelheim Investigational Site

Landen, Belgium

Location

1245.20.32019 Boehringer Ingelheim Investigational Site

Leopoldsburg, Belgium

Location

1245.20.32024 Boehringer Ingelheim Investigational Site

Linkebeek, Belgium

Location

1245.20.32021 Boehringer Ingelheim Investigational Site

Mouscron, Belgium

Location

1245.20.32027 Boehringer Ingelheim Investigational Site

Retie, Belgium

Location

1245.20.32020 Boehringer Ingelheim Investigational Site

Sint-Gillis-Waas, Belgium

Location

1245.20.32018 Boehringer Ingelheim Investigational Site

Tielt, Belgium

Location

1245.20.32026 Boehringer Ingelheim Investigational Site

Tremelo, Belgium

Location

1245.20.20011 Boehringer Ingelheim Investigational Site

Chilliwack, British Columbia, Canada

Location

1245.20.20018 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

Location

1245.20.20015 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Location

1245.20.20012 Boehringer Ingelheim Investigational Site

Moncton, New Brunswick, Canada

Location

1245.20.20016 Boehringer Ingelheim Investigational Site

Mount Pearl, Newfoundland and Labrador, Canada

Location

1245.20.20008 Boehringer Ingelheim Investigational Site

St. John's, Newfoundland and Labrador, Canada

Location

1245.20.20001 Boehringer Ingelheim Investigational Site

Barrie, Ontario, Canada

Location

1245.20.20019 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1245.20.20010 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Location

1245.20.20017 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Location

1245.20.20003 Boehringer Ingelheim Investigational Site

Markham, Ontario, Canada

Location

1245.20.20009 Boehringer Ingelheim Investigational Site

Newmarket, Ontario, Canada

Location

1245.20.20013 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Location

1245.20.20005 Boehringer Ingelheim Investigational Site

Strathroy, Ontario, Canada

Location

1245.20.20002 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1245.20.20006 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1245.20.20014 Boehringer Ingelheim Investigational Site

Charlottetown, Prince Edward Island, Canada

Location

1245.20.20007 Boehringer Ingelheim Investigational Site

Montague, Prince Edward Island, Canada

Location

1245.20.20021 Boehringer Ingelheim Investigational Site

Trois-Rivières, Quebec, Canada

Location

1245.20.86007 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1245.20.86008 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1245.20.86001 Boehringer Ingelheim Investigational Site

Guangzhou, China

Location

1245.20.86002 Boehringer Ingelheim Investigational Site

Guangzhou, China

Location

1245.20.86003 Boehringer Ingelheim Investigational Site

Guangzhou, China

Location

1245.20.86012 Boehringer Ingelheim Investigational Site

Guiyang, China

Location

1245.20.86020 Boehringer Ingelheim Investigational Site

Hangzhou, China

Location

1245.20.86049 Boehringer Ingelheim Investigational Site

Jinan, China

Location

1245.20.86018 Boehringer Ingelheim Investigational Site

Jingzhou, China

Location

1245.20.86019 Boehringer Ingelheim Investigational Site

Nanchang, China

Location

1245.20.86010 Boehringer Ingelheim Investigational Site

Nanjing, China

Location

1245.20.86043 Boehringer Ingelheim Investigational Site

Nanjing, China

Location

1245.20.86016 Boehringer Ingelheim Investigational Site

Qingdao, China

Location

1245.20.86004 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1245.20.86005 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1245.20.86006 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1245.20.86057 Boehringer Ingelheim Investigational Site

Shenyang, China

Location

1245.20.86017 Boehringer Ingelheim Investigational Site

Shiyan, China

Location

1245.20.86013 Boehringer Ingelheim Investigational Site

Suzhou, China

Location

1245.20.86015 Boehringer Ingelheim Investigational Site

Taiyuan, China

Location

1245.20.86009 Boehringer Ingelheim Investigational Site

Wuhan, China

Location

1245.20.86011 Boehringer Ingelheim Investigational Site

Xi'an, China

Location

1245.20.86014 Boehringer Ingelheim Investigational Site

Xiamen, China

Location

1245.20.49013 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

1245.20.49016 Boehringer Ingelheim Investigational Site

Düsseldorf, Germany

Location

1245.20.49015 Boehringer Ingelheim Investigational Site

Frankfurt, Germany

Location

1245.20.49019 Boehringer Ingelheim Investigational Site

Haag, Germany

Location

1245.20.49020 Boehringer Ingelheim Investigational Site

Hohenmölsen, Germany

Location

1245.20.49014 Boehringer Ingelheim Investigational Site

Köthen, Germany

Location

1245.20.49002 Boehringer Ingelheim Investigational Site

Neuwied, Germany

Location

1245.20.49008 Boehringer Ingelheim Investigational Site

Nuremberg, Germany

Location

1245.20.49017 Boehringer Ingelheim Investigational Site

Saint Ingbert/Oberwürzbach, Germany

Location

1245.20.49022 Boehringer Ingelheim Investigational Site

Schauenburg, Germany

Location

1245.20.49003 Boehringer Ingelheim Investigational Site

Unterschneidheim, Germany

Location

1245.20.91005 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1245.20.91006 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1245.20.91008 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1245.20.91003 Boehringer Ingelheim Investigational Site

Belagavi, India

Location

1245.20.91004 Boehringer Ingelheim Investigational Site

Chennai, India

Location

1245.20.91009 Boehringer Ingelheim Investigational Site

Chennai, India

Location

1245.20.91002 Boehringer Ingelheim Investigational Site

Mumbai, India

Location

1245.20.91007 Boehringer Ingelheim Investigational Site

Mumbai, Maharastra, India

Location

1245.20.91010 Boehringer Ingelheim Investigational Site

Nagpur, India

Location

1245.20.91001 Boehringer Ingelheim Investigational Site

Tamil Nadu, India

Location

1245.20.35302 Boehringer Ingelheim Investigational Site

Co. Cork, Ireland

Location

1245.20.35305 Boehringer Ingelheim Investigational Site

Co. Galway, Ireland

Location

1245.20.35303 Boehringer Ingelheim Investigational Site

Co. Wexford, Ireland

Location

1245.20.35304 Boehringer Ingelheim Investigational Site

Offaly, Ireland

Location

1245.20.35306 Boehringer Ingelheim Investigational Site

Wexford, Ireland

Location

1245.20.81007 Boehringer Ingelheim Investigational Site

Chiyoda-ku, Tokyo, Japan

Location

1245.20.81001 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, Japan

Location

1245.20.81002 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, Japan

Location

1245.20.81005 Boehringer Ingelheim Investigational Site

Ebetsu, Hokkaido, Japan

Location

1245.20.81004 Boehringer Ingelheim Investigational Site

Kamakura, Kanagawa, Japan

Location

1245.20.81003 Boehringer Ingelheim Investigational Site

Minato-ku, Tokyo, Japan

Location

1245.20.81006 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, Japan

Location

1245.20.81008 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, Japan

Location

1245.20.81009 Boehringer Ingelheim Investigational Site

Suita, Osaka, Japan

Location

1245.20.81010 Boehringer Ingelheim Investigational Site

Ube, Yamaguchi, Japan

Location

1245.20.81012 Boehringer Ingelheim Investigational Site

Urasoe, Okinawa, Japan

Location

1245.20.81013 Boehringer Ingelheim Investigational Site

Urasoe, Okinawa, Japan

Location

1245.20.41004 Boehringer Ingelheim Investigational Site

Lugano, Switzerland

Location

1245.20.41003 Boehringer Ingelheim Investigational Site

Rorschach, Switzerland

Location

Related Publications (4)

• Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

  PMID: 38770818 DERIVED

• 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.

  PMID: 35472672 DERIVED

• 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.

  PMID: 27316632 DERIVED

• 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.

  PMID: 24622369 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: August 9, 2010
• Study Start: July 1, 2010
• Primary Completion: March 1, 2012
• Last Updated: June 16, 2014
• Results First Posted: June 16, 2014

Record last verified: 2014-05

Locations

CH (2); BE (15); IE (5); US (27); CA (19); IN (10); DE (11); JP (12); CN (23)