Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes

NCT01011868 | Completed Phase 2 Results

• 2 other identifiers: 1245.332009-013668-38
• Study Type: interventional
• Target: 494
• Locations: 7 countries
• Sites: 99

Brief Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment

  Change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment

  Baseline and 18 weeks

Secondary Outcomes (8)

• Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5%) After 18, 54 and 78 Weeks of Treatment

  Baseline and 18, 54 and 78 weeks

• Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment

  Baseline, 18, 54 and 78 weeks

• Percent Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment

  Baseline, 18, 54 and 78 weeks

• Change From Baseline in Basal Insulin Dose/Day After 54 and 78 Weeks of Treatment

  Baseline, 54 and 78 weeks

• Change From Baseline in Body Weight After 18, 54 and 78 Weeks of Treatment

  Baseline, 18, 54, 78 weeks

Other Outcomes (1)

• Confirmed Hypoglycemic Events

  During the course of the study (82 weeks)

Study Arms (3)

BI 10773 low dose

EXPERIMENTAL

Patients receive BI 10773 low dose daily

Drug: BI 10773 low dose

BI 10773 high dose

EXPERIMENTAL

Patients receive BI 10773 high dose daily

Drug: BI 10773 placebo; Drug: BI 10773 high dose

placebo

PLACEBO COMPARATOR

Patients receive placebo to match BI 10773 daily

Drug: BI 10773 placebo

Interventions

BI 10773 placebo DRUG

BI 10773 placebo

BI 10773 high dose

BI 10773 low dose DRUG

BI 10773 low dose

BI 10773 low dose

BI 10773 high dose DRUG

BI 10773 high dose

BI 10773 high dose

Eligibility Criteria

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

You may qualify if:

• Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation
• Male and female patients with a diagnosis of Type 2 Diabetes Mellitus treated with a stable dose of basal insulin with or without concomitant metformin and / or sulfonylurea.
• Glycosylated hemoglobin A1c (Type A, subtype 1c) of \>7.0% and \< or = 10% at Visit 1 (screening)
• Suitability for trial participation according to investigator's judgment (evaluating all alternative treatment options and in consideration of the patient completing the study)
• Age \> or =18 years at Visit 1 (screening)
• BMI \< or = 45 kg/m2 (Body Mass Index) at Visit 1 (screening)

You may not qualify if:

• Patients with poorly controlled hyperglycemia
• Frequent (at the discretion of the investigator) episodes of hypoglycemic events on basal insulin therapy
• MI, stroke, or TIA within 3 months prior to obtaining informed consent
• Impaired hepatic or renal function; gastric surgery; cancer within the last 5 years; blood dyscrasias
• \. Treatment with other anti-diabetics, anti-obesity medications, steroids or thyroid hormones, participation in another trial with an investigational drug 7. Pre-menopausal women on insufficient birth control 8. Alcohol or drug abuse

Sponsors & Collaborators

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

Study Sites (99)

1245.33.01014 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

1245.33.01047 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

1245.33.01060 Boehringer Ingelheim Investigational Site

Fresno, California, United States

Location

1245.33.01013 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1245.33.01008 Boehringer Ingelheim Investigational Site

Los Gatos, California, United States

Location

1245.33.01019 Boehringer Ingelheim Investigational Site

National City, California, United States

Location

1245.33.01055 Boehringer Ingelheim Investigational Site

Paramount, California, United States

Location

1245.33.01012 Boehringer Ingelheim Investigational Site

Santa Ana, California, United States

Location

1245.33.01054 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

1245.33.01046 Boehringer Ingelheim Investigational Site

Bradednton, Florida, United States

Location

1245.33.01050 Boehringer Ingelheim Investigational Site

Brooksville, Florida, United States

Location

1245.33.01059 Boehringer Ingelheim Investigational Site

Chiefland, Florida, United States

Location

1245.33.01028 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Location

1245.33.01029 Boehringer Ingelheim Investigational Site

Fleming Island, Florida, United States

Location

1245.33.01048 Boehringer Ingelheim Investigational Site

Hollywood, Florida, United States

Location

1245.33.01033 Boehringer Ingelheim Investigational Site

New Port Richey, Florida, United States

Location

1245.33.01027 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

1245.33.01040 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

Location

1245.33.01062 Boehringer Ingelheim Investigational Site

Lawrenceville, Georgia, United States

Location

1245.33.01020 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1245.33.01044 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1245.33.01024 Boehringer Ingelheim Investigational Site

Des Moines, Iowa, United States

Location

1245.33.01022 Boehringer Ingelheim Investigational Site

Saint Louis, Maryland, United States

Location

1245.33.01056 Boehringer Ingelheim Investigational Site

Olive Branch, Mississippi, United States

Location

1245.33.01032 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Location

1245.33.01017 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Location

1245.33.01043 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

Location

1245.33.01051 Boehringer Ingelheim Investigational Site

New Hartford, New York, United States

Location

1245.33.01007 Boehringer Ingelheim Investigational Site

Greensboro, North Carolina, United States

Location

1245.33.01003 Boehringer Ingelheim Investigational Site

Jacksonville, North Carolina, United States

Location

1245.33.01016 Boehringer Ingelheim Investigational Site

Salisbury, North Carolina, United States

Location

1245.33.01005 Boehringer Ingelheim Investigational Site

Statesville, North Carolina, United States

Location

1245.33.01038 Boehringer Ingelheim Investigational Site

Wilmington, North Carolina, United States

Location

1245.33.01026 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

1245.33.01025 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

1245.33.01001 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

1245.33.01031 Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

Location

1245.33.01045 Boehringer Ingelheim Investigational Site

Eugene, Oregon, United States

Location

1245.33.01018 Boehringer Ingelheim Investigational Site

Altoona, Pennsylvania, United States

Location

1245.33.01041 Boehringer Ingelheim Investigational Site

Carlisle, Pennsylvania, United States

Location

1245.33.01042 Boehringer Ingelheim Investigational Site

Landsdale, Pennsylvania, United States

Location

1245.33.01004 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

Location

1245.33.01036 Boehringer Ingelheim Investigational Site

Mt. Pleasant, South Carolina, United States

Location

1245.33.01035 Boehringer Ingelheim Investigational Site

Seneca, South Carolina, United States

Location

1245.33.01058 Boehringer Ingelheim Investigational Site

Kingsport, Tennessee, United States

Location

1245.33.01037 Boehringer Ingelheim Investigational Site

Memphis, Tennessee, United States

Location

1245.33.01023 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1245.33.01030 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1245.33.01006 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1245.33.01011 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1245.33.01002 Boehringer Ingelheim Investigational Site

Sugar Land, Texas, United States

Location

1245.33.01049 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Location

1245.33.01015 Boehringer Ingelheim Investigational Site

Norfolk, Virginia, United States

Location

1245.33.01009 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

1245.33.01010 Boehringer Ingelheim Investigational Site

Federal Way, Washington, United States

Location

1245.33.01061 Boehringer Ingelheim Investigational Site

Milwaukee, Wisconsin, United States

Location

1245.33.45006 Boehringer Ingelheim Investigational Site

Aalborg, Denmark

Location

1245.33.45001 Boehringer Ingelheim Investigational Site

Aarhus C, Denmark

Location

1245.33.45011 Boehringer Ingelheim Investigational Site

Aarhus C, Denmark

Location

1245.33.45013 Boehringer Ingelheim Investigational Site

Aarhus C, Denmark

Location

1245.33.45004 Boehringer Ingelheim Investigational Site

Gentofte Municipality, Denmark

Location

1245.33.45008 Boehringer Ingelheim Investigational Site

Hillerød, Denmark

Location

1245.33.45002 Boehringer Ingelheim Investigational Site

Hvidovre, Denmark

Location

1245.33.45003 Boehringer Ingelheim Investigational Site

København NV, Denmark

Location

1245.33.3301A Boehringer Ingelheim Investigational Site

Bondy, France

Location

1245.33.3302A Boehringer Ingelheim Investigational Site

Corbeil-Essonnes, France

Location

1245.33.3305A Boehringer Ingelheim Investigational Site

La Rochelle, France

Location

1245.33.3306A Boehringer Ingelheim Investigational Site

Marseille, France

Location

1245.33.3308A Boehringer Ingelheim Investigational Site

Montbrison, France

Location

1245.33.3309A Boehringer Ingelheim Investigational Site

Nanterre, France

Location

1245.33.3310A Boehringer Ingelheim Investigational Site

Nantes, France

Location

1245.33.3304A Boehringer Ingelheim Investigational Site

Narbonne, France

Location

1245.33.3303A Boehringer Ingelheim Investigational Site

Saint-Mandé, France

Location

1245.33.35302 Boehringer Ingelheim Investigational Site

Dublin, Ireland

Location

1245.33.35303 Boehringer Ingelheim Investigational Site

Dublin, Ireland

Location

1245.33.35304 Boehringer Ingelheim Investigational Site

Dublin, Ireland

Location

1245.33.35104 Boehringer Ingelheim Investigational Site

Aveiro, Portugal

Location

1245.33.35101 Boehringer Ingelheim Investigational Site

Coimbra, Portugal

Location

1245.33.35102 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1245.33.35106 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1245.33.35107 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1245.33.82008 Boehringer Ingelheim Investigational Site

Daejeon, South Korea

Location

1245.33.82007 Boehringer Ingelheim Investigational Site

Gwangju, South Korea

Location

1245.33.82001 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1245.33.82003 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1245.33.82004 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1245.33.82005 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1245.33.82006 Boehringer Ingelheim Investigational Site

Wŏnju, South Korea

Location

1245.33.82002 Boehringer Ingelheim Investigational Site

Yangsan, South Korea

Location

1245.33.44001 Boehringer Ingelheim Investigational Site

Bath, United Kingdom

Location

1245.33.44003 Boehringer Ingelheim Investigational Site

Birmingham, United Kingdom

Location

1245.33.44006 Boehringer Ingelheim Investigational Site

Blackburn, United Kingdom

Location

1245.33.44005 Boehringer Ingelheim Investigational Site

Dorking, United Kingdom

Location

1245.33.44009 Boehringer Ingelheim Investigational Site

Headington, United Kingdom

Location

1245.33.44008 Boehringer Ingelheim Investigational Site

Leicester, United Kingdom

Location

1245.33.44004 Boehringer Ingelheim Investigational Site

Liverpool, United Kingdom

Location

1245.33.44007 Boehringer Ingelheim Investigational Site

Wembley, United Kingdom

Location

1245.33.44002 Boehringer Ingelheim Investigational Site

Whitstable, United Kingdom

Location

1245.33.44010 Boehringer Ingelheim Investigational Site

Wymondham, United Kingdom

Location

Related Publications (1)

• 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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

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

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2009
• First Posted: November 11, 2009
• Study Start: November 1, 2009
• Primary Completion: May 1, 2012
• Last Updated: September 30, 2014
• Results First Posted: September 30, 2014

Record last verified: 2014-09

Locations

FR (9); KR (8); PT (5); DK (8); US (56); GB (10); IE (3)