Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus

NCT01306214 | Completed Phase 3 Results

• 2 other identifiers: 1245.492010-019968-37
• Study Type: interventional
• Target: 566
• Locations: 14 countries
• Sites: 103

Brief Summary

This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic option in this population.

Conditions

Diabetes Mellitus, Type 2; Obesity

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c After 18 Weeks of Treatment

  The primary endpoint was the change from baseline in HbA1c after 18 weeks of treatment.

  Baseline and 18 weeks

Secondary Outcomes (3)

• Change From Baseline in Insulin Dose After 52 Weeks of Treatment

  Baseline and 52 weeks

• Change From Baseline in Body Weight After 52 Weeks of Treatment

  Baseline and 52 weeks

• Change From Baseline in HbA1c After 52 Weeks of Treatment

  Baseline and 52 weeks

Study Arms (3)

BI 10773 low dose

EXPERIMENTAL

BI 10773 low dose once daily

Drug: Placebo; Drug: BI 10773

BI 10773 high dose

EXPERIMENTAL

BI 10733 high dose once daily

Drug: Placebo; Drug: BI 10773

Placebo

PLACEBO COMPARATOR

Placebo tablets matching BI 10773

Drug: Placebo

Interventions

Placebo DRUG

Placebo matching BI 10773 low dose

Placebo

BI 10773 DRUG

BI 10773 low dose 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 T2DM prior to informed consent
• Male and female patients on diet and exercise regimen who are pre-treated with multiple daily injections (MDI) of insulin alone or in combination with immediate or extended release metformin
• Stable metformin therapy: daily dose \>=1500 mg/day or maximum tolerated dose
• HbA1c \>=7.5% and \<=10% at screening

You may not qualify if:

• Uncontrolled hyperglycemia with a glucose level \>240 mg/dl (\>13.3 mmol/L) after an overnight fast during placebo run-in
• Any contraindications to metformin according to the local label
• Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent

Sponsors & Collaborators

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

Study Sites (103)

1245.49.10005 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

1245.49.10011 Boehringer Ingelheim Investigational Site

Chandler, Arizona, United States

Location

1245.49.10004 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

Location

1245.49.10002 Boehringer Ingelheim Investigational Site

Corona, California, United States

Location

1245.49.10013 Boehringer Ingelheim Investigational Site

El Cajon, California, United States

Location

1245.49.10030 Boehringer Ingelheim Investigational Site

Lomita, California, United States

Location

1245.49.10014 Boehringer Ingelheim Investigational Site

Spring Valley, California, United States

Location

1245.49.10019 Boehringer Ingelheim Investigational Site

Westlake Village, California, United States

Location

1245.49.10024 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

1245.49.10018 Boehringer Ingelheim Investigational Site

Hialeah, Florida, United States

Location

1245.49.10016 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1245.49.10021 Boehringer Ingelheim Investigational Site

Blue Ridge, Georgia, United States

Location

1245.49.10009 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1245.49.10015 Boehringer Ingelheim Investigational Site

Evansville, Indiana, United States

Location

1245.49.10023 Boehringer Ingelheim Investigational Site

Greenville, North Carolina, United States

Location

1245.49.10007 Boehringer Ingelheim Investigational Site

Fargo, North Dakota, United States

Location

1245.49.10006 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

1245.49.10025 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

Location

1245.49.10022 Boehringer Ingelheim Investigational Site

Memphis, Tennessee, United States

Location

1245.49.10003 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Location

1245.49.10001 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1245.49.10031 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1245.49.10033 Boehringer Ingelheim Investigational Site

Bountiful, Utah, United States

Location

1245.49.10032 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Location

1245.49.10026 Boehringer Ingelheim Investigational Site

Norfolk, Virginia, United States

Location

1245.49.10020 Boehringer Ingelheim Investigational Site

Renton, Washington, United States

Location

1245.49.32010 Boehringer Ingelheim Investigational Site

Bonheiden, Belgium

Location

1245.49.32002 Boehringer Ingelheim Investigational Site

Edegem, Belgium

Location

1245.49.32007 Boehringer Ingelheim Investigational Site

Huy, Belgium

Location

1245.49.32014 Boehringer Ingelheim Investigational Site

Jette, Belgium

Location

1245.49.32013 Boehringer Ingelheim Investigational Site

La Louvière, Belgium

Location

1245.49.32012 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

1245.49.59003 Boehringer Ingelheim Investigational Site

Pleven, Bulgaria

Location

1245.49.59004 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1245.49.59001 Boehringer Ingelheim Investigational Site

Stara Zagora, Bulgaria

Location

1245.49.57003 Boehringer Ingelheim Investigational Site

Barranquilla, Colombia

Location

1245.49.57004 Boehringer Ingelheim Investigational Site

Bogotá, Colombia

Location

1245.49.57005 Boehringer Ingelheim Investigational Site

Bogotá, Colombia

Location

1245.49.57006 Boehringer Ingelheim Investigational Site

Bogotá, Colombia

Location

1245.49.57002 Boehringer Ingelheim Investigational Site

Medellín, Colombia

Location

1245.49.42003 Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

1245.49.42010 Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

1245.49.42013 Boehringer Ingelheim Investigational Site

Břeclav, Czechia

Location

1245.49.42011 Boehringer Ingelheim Investigational Site

Chrudim, Czechia

Location

1245.49.42009 Boehringer Ingelheim Investigational Site

Hodonín, Czechia

Location

1245.49.42012 Boehringer Ingelheim Investigational Site

Svitavy56802, Czechia

Location

1245.49.72001 Boehringer Ingelheim Investigational Site

Kuopio, Finland

Location

1245.49.72002 Boehringer Ingelheim Investigational Site

Oulu, Finland

Location

1245.49.72003 Boehringer Ingelheim Investigational Site

Turku, Finland

Location

1245.49.33001 Boehringer Ingelheim Investigational Site

Grenoble, France

Location

1245.49.33011 Boehringer Ingelheim Investigational Site

Le Creusot, France

Location

1245.49.33012 Boehringer Ingelheim Investigational Site

Marseille, France

Location

1245.49.33003 Boehringer Ingelheim Investigational Site

Nantes, France

Location

1245.49.33010 Boehringer Ingelheim Investigational Site

Narbonne, France

Location

1245.49.33004 Boehringer Ingelheim Investigational Site

Pierre-Bénite, France

Location

1245.49.33007 Boehringer Ingelheim Investigational Site

Point-à-Pitre Cedex, France

Location

1245.49.33008 Boehringer Ingelheim Investigational Site

Saint-Priest-en-Jarez, France

Location

1245.49.33009 Boehringer Ingelheim Investigational Site

Vénissieux, France

Location

1245.49.49104 Boehringer Ingelheim Investigational Site

Bosenheim, Germany

Location

1245.49.49013 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

1245.49.49101 Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

1245.49.49002 Boehringer Ingelheim Investigational Site

Neuwied, Germany

Location

1245.49.49005 Boehringer Ingelheim Investigational Site

Saarbrücken, Germany

Location

1245.49.49102 Boehringer Ingelheim Investigational Site

Wangen, Germany

Location

1245.49.50201 Boehringer Ingelheim Investigational Site

Guatemala City, Guatemala

Location

1245.49.50202 Boehringer Ingelheim Investigational Site

Guatemala City, Guatemala

Location

1245.49.50203 Boehringer Ingelheim Investigational Site

Guatemala City, Guatemala

Location

1245.49.50204 Boehringer Ingelheim Investigational Site

Guatemala City, Guatemala

Location

1245.49.50205 Boehringer Ingelheim Investigational Site

Quetzaltenango, Guatemala

Location

1245.49.52011 Boehringer Ingelheim Investigational Site

Aguascalientes, Mexico

Location

1245.49.52012 Boehringer Ingelheim Investigational Site

Cuautla, Mexico

Location

1245.49.52003 Boehringer Ingelheim Investigational Site

Durango, Mexico

Location

1245.49.52005 Boehringer Ingelheim Investigational Site

Durango, Mexico

Location

1245.49.52004 Boehringer Ingelheim Investigational Site

Guadalajara, Mexico

Location

1245.49.52006 Boehringer Ingelheim Investigational Site

Guadalajara, Mexico

Location

1245.49.52008 Boehringer Ingelheim Investigational Site

Guadalajara, Mexico

Location

1245.49.52001 Boehringer Ingelheim Investigational Site

México, D.F., Mexico

Location

1245.49.52002 Boehringer Ingelheim Investigational Site

Monterrey, Mexico

Location

1245.49.52009 Boehringer Ingelheim Investigational Site

Monterrey, Mexico

Location

1245.49.52010 Boehringer Ingelheim Investigational Site

Monterrey, Mexico

Location

1245.49.51002 Boehringer Ingelheim Investigational Site

Arequipa, Peru

Location

1245.49.51006 Boehringer Ingelheim Investigational Site

Arequipa, Peru

Location

1245.49.51010 Boehringer Ingelheim Investigational Site

Jesus Maria, Peru

Location

1245.49.51001 Boehringer Ingelheim Investigational Site

Lima, Peru

Location

1245.49.51008 Boehringer Ingelheim Investigational Site

Lima, Peru

Location

1245.49.51009 Boehringer Ingelheim Investigational Site

Lima, Peru

Location

1245.49.70008 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1245.49.70009 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1245.49.70006 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1245.49.70010 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1245.49.34039 Boehringer Ingelheim Investigational Site

Ávila, Spain

Location

1245.49.34038 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1245.49.34044 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1245.49.34043 Boehringer Ingelheim Investigational Site

MBoadilla Del Monte (Madrid), Spain

Location

1245.49.34047 Boehringer Ingelheim Investigational Site

Palma de Mallorca, Spain

Location

1245.49.34045 Boehringer Ingelheim Investigational Site

Pozuelo de Alarcón, Spain

Location

1245.49.34016 Boehringer Ingelheim Investigational Site

Santiago de Compostela (La Coruña), Spain

Location

1245.49.34041 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1245.49.75016 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1245.49.75007 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1245.49.75014 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1245.49.75015 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1245.49.75013 Boehringer Ingelheim Investigational Site

Kyiv, Ukraine

Location

Related Publications (2)

• 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

• Rosenstock J, Jelaska A, Frappin G, Salsali A, Kim G, Woerle HJ, Broedl UC; EMPA-REG MDI Trial Investigators. Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes. Diabetes Care. 2014 Jul;37(7):1815-23. doi: 10.2337/dc13-3055. Epub 2014 Jun 14.

  PMID: 24929430 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: February 28, 2011
• First Posted: March 1, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 17, 2014
• Results First Posted: June 17, 2014

Record last verified: 2014-05

Locations

GU (5); PE (6); CO (5); FR (9); DE (6); RU (4); US (26); ES (8); CZ (6); BU (3); FI (3); UA (5); ME (11); BE (6)