Clinical trial NCT01011868: Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes
Official title: A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Safety and Efficacy Study of BI 10773 (10 mg and 25 mg) Administered Orally, Once Daily Over 78 Weeks in Type 2 Diabetic Patients Receiving Treatment With Basal Insulin (Glargine, Detemir, or NPH Insulin Only) With or Without Concomitant Metformin and/or Sulfonylurea Therapy and Insufficient Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2009-11-11
Enrollment: 494
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 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.


Eligibility criteria: Inclusion criteria:

1. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation
2. 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.
3. Glycosylated hemoglobin A1c (Type A, subtype 1c) of \>7.0% and \< or = 10% at Visit 1 (screening)
4. Suitability for trial participation according to investigator's judgment (evaluating all alternative treatment options and in consideration of the patient completing the study)
5. Age \> or =18 years at Visit 1 (screening)
6. BMI \< or = 45 kg/m2 (Body Mass Index) at Visit 1 (screening)

Exclusion criteria:

1. Patients with poorly controlled hyperglycemia
2. Frequent (at the discretion of the investigator) episodes of hypoglycemic events on basal insulin therapy
3. MI, stroke, or TIA within 3 months prior to obtaining informed consent
4. Impaired hepatic or renal function; gastric surgery; cancer within the last 5 years; blood dyscrasias

6. 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

Primary outcomes:
measure: Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment
timeFrame: Baseline and 18 weeks
Secondary outcomes:
measure: Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5%) After 18, 54 and 78 Weeks of Treatment
timeFrame: Baseline and 18, 54 and 78 weeks
measure: Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment
timeFrame: Baseline, 18, 54 and 78 weeks
measure: Percent Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment
timeFrame: Baseline, 18, 54 and 78 weeks
measure: Change From Baseline in Basal Insulin Dose/Day After 54 and 78 Weeks of Treatment
timeFrame: Baseline, 54 and 78 weeks
measure: Change From Baseline in Body Weight After 18, 54 and 78 Weeks of Treatment
timeFrame: Baseline, 18, 54, 78 weeks
measure: Change From Baseline in Body Weight at Follow-up
timeFrame: Baseline and 82 weeks
measure: Change From Baseline in HbA1c After 54 and 78 Weeks of Treatment
timeFrame: Baseline, 54 and 78 weeks
measure: The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 18, 54, and 78 Weeks of Treatment
timeFrame: Baseline, 18, 54 and 78 weeks
Other outcomes:
measure: Confirmed Hypoglycemic Events
timeFrame: During the course of the study (82 weeks)
Locations:
city: Birmingham
country: United States
facility: 1245.33.01014 Boehringer Ingelheim Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: 1245.33.01047 Boehringer Ingelheim Investigational Site
state: Arizona
city: Fresno
country: United States
facility: 1245.33.01060 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 1245.33.01013 Boehringer Ingelheim Investigational Site
state: California
city: Los Gatos
country: United States
facility: 1245.33.01008 Boehringer Ingelheim Investigational Site
state: California
city: National City
country: United States
facility: 1245.33.01019 Boehringer Ingelheim Investigational Site
state: California
city: Paramount
country: United States
facility: 1245.33.01055 Boehringer Ingelheim Investigational Site
state: California
city: Santa Ana
country: United States
facility: 1245.33.01012 Boehringer Ingelheim Investigational Site
state: California
city: Denver
country: United States
facility: 1245.33.01054 Boehringer Ingelheim Investigational Site
state: Colorado
city: Bradednton
country: United States
facility: 1245.33.01046 Boehringer Ingelheim Investigational Site
state: Florida
city: Brooksville
country: United States
facility: 1245.33.01050 Boehringer Ingelheim Investigational Site
state: Florida
city: Chiefland
country: United States
facility: 1245.33.01059 Boehringer Ingelheim Investigational Site
state: Florida
city: Clearwater
country: United States
facility: 1245.33.01028 Boehringer Ingelheim Investigational Site
state: Florida
city: Fleming Island
country: United States
facility: 1245.33.01029 Boehringer Ingelheim Investigational Site
state: Florida
city: Hollywood
country: United States
facility: 1245.33.01048 Boehringer Ingelheim Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: 1245.33.01033 Boehringer Ingelheim Investigational Site
state: Florida
city: Atlanta
country: United States
facility: 1245.33.01027 Boehringer Ingelheim Investigational Site
state: Georgia
city: Decatur
country: United States
facility: 1245.33.01040 Boehringer Ingelheim Investigational Site
state: Georgia
city: Lawrenceville
country: United States
facility: 1245.33.01062 Boehringer Ingelheim Investigational Site
state: Georgia
city: Chicago
country: United States
facility: 1245.33.01020 Boehringer Ingelheim Investigational Site
state: Illinois
city: Chicago
country: United States
facility: 1245.33.01044 Boehringer Ingelheim Investigational Site
state: Illinois
city: Des Moines
country: United States
facility: 1245.33.01024 Boehringer Ingelheim Investigational Site
state: Iowa
city: St. Louis
country: United States
facility: 1245.33.01022 Boehringer Ingelheim Investigational Site
state: Maryland
city: Olive Branch
country: United States
facility: 1245.33.01056 Boehringer Ingelheim Investigational Site
state: Mississippi
city: Kansas City
country: United States
facility: 1245.33.01032 Boehringer Ingelheim Investigational Site
state: Missouri
city: Omaha
country: United States
facility: 1245.33.01017 Boehringer Ingelheim Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: 1245.33.01043 Boehringer Ingelheim Investigational Site
state: Nevada
city: New Hartford
country: United States
facility: 1245.33.01051 Boehringer Ingelheim Investigational Site
state: New York
city: Greensboro
country: United States
facility: 1245.33.01007 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Jacksonville
country: United States
facility: 1245.33.01003 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: 1245.33.01016 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Statesville
country: United States
facility: 1245.33.01005 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: 1245.33.01038 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: 1245.33.01026 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: 1245.33.01025 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 1245.33.01001 Boehringer Ingelheim Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: 1245.33.01031 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: 1245.33.01045 Boehringer Ingelheim Investigational Site
state: Oregon
city: Altoona
country: United States
facility: 1245.33.01018 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Carlisle
country: United States
facility: 1245.33.01041 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Landsdale
country: United States
facility: 1245.33.01042 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Greer
country: United States
facility: 1245.33.01004 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Mt. Pleasant
country: United States
facility: 1245.33.01036 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Seneca
country: United States
facility: 1245.33.01035 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Kingsport
country: United States
facility: 1245.33.01058 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: 1245.33.01037 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: 1245.33.01023 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 1245.33.01030 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1245.33.01006 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1245.33.01011 Boehringer Ingelheim Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: 1245.33.01002 Boehringer Ingelheim Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: 1245.33.01049 Boehringer Ingelheim Investigational Site
state: Utah
city: Norfolk
country: United States
facility: 1245.33.01015 Boehringer Ingelheim Investigational Site
state: Virginia
city: Richmond
country: United States
facility: 1245.33.01009 Boehringer Ingelheim Investigational Site
state: Virginia
city: Federal Way
country: United States
facility: 1245.33.01010 Boehringer Ingelheim Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: 1245.33.01061 Boehringer Ingelheim Investigational Site
state: Wisconsin
city: Aalborg
country: Denmark
facility: 1245.33.45006 Boehringer Ingelheim Investigational Site
city: Aarhus C
country: Denmark
facility: 1245.33.45001 Boehringer Ingelheim Investigational Site
city: Aarhus C
country: Denmark
facility: 1245.33.45011 Boehringer Ingelheim Investigational Site
city: Aarhus C
country: Denmark
facility: 1245.33.45013 Boehringer Ingelheim Investigational Site
city: Gentofte
country: Denmark
facility: 1245.33.45004 Boehringer Ingelheim Investigational Site
city: Hillerød
country: Denmark
facility: 1245.33.45008 Boehringer Ingelheim Investigational Site
city: Hvidovre
country: Denmark
facility: 1245.33.45002 Boehringer Ingelheim Investigational Site
city: København NV
country: Denmark
facility: 1245.33.45003 Boehringer Ingelheim Investigational Site
city: Bondy Cedex
country: France
facility: 1245.33.3301A Boehringer Ingelheim Investigational Site
city: Corbeil Essonnes
country: France
facility: 1245.33.3302A Boehringer Ingelheim Investigational Site
city: La Rochelle Cedex 1
country: France
facility: 1245.33.3305A Boehringer Ingelheim Investigational Site
city: Marseille
country: France
facility: 1245.33.3306A Boehringer Ingelheim Investigational Site
city: Montbrison
country: France
facility: 1245.33.3308A Boehringer Ingelheim Investigational Site
city: Nanterre Cedex
country: France
facility: 1245.33.3309A Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1245.33.3310A Boehringer Ingelheim Investigational Site
city: Narbonne Cedex
country: France
facility: 1245.33.3304A Boehringer Ingelheim Investigational Site
city: Saint Mandé
country: France
facility: 1245.33.3303A Boehringer Ingelheim Investigational Site
city: Dublin
country: Ireland
facility: 1245.33.35302 Boehringer Ingelheim Investigational Site
city: Dublin
country: Ireland
facility: 1245.33.35303 Boehringer Ingelheim Investigational Site
city: Dublin
country: Ireland
facility: 1245.33.35304 Boehringer Ingelheim Investigational Site
city: Daejeon
country: Korea, Republic of
facility: 1245.33.82008 Boehringer Ingelheim Investigational Site
city: Gwangju
country: Korea, Republic of
facility: 1245.33.82007 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1245.33.82001 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1245.33.82003 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1245.33.82004 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1245.33.82005 Boehringer Ingelheim Investigational Site
city: Wonju
country: Korea, Republic of
facility: 1245.33.82006 Boehringer Ingelheim Investigational Site
city: Yangsan
country: Korea, Republic of
facility: 1245.33.82002 Boehringer Ingelheim Investigational Site
city: Aveiro
country: Portugal
facility: 1245.33.35104 Boehringer Ingelheim Investigational Site
city: Coimbra
country: Portugal
facility: 1245.33.35101 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 1245.33.35102 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 1245.33.35106 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 1245.33.35107 Boehringer Ingelheim Investigational Site
city: Bath
country: United Kingdom
facility: 1245.33.44001 Boehringer Ingelheim Investigational Site
city: Birmingham
country: United Kingdom
facility: 1245.33.44003 Boehringer Ingelheim Investigational Site
city: Blackburn
country: United Kingdom
facility: 1245.33.44006 Boehringer Ingelheim Investigational Site
city: Dorking
country: United Kingdom
facility: 1245.33.44005 Boehringer Ingelheim Investigational Site
city: Headington
country: United Kingdom
facility: 1245.33.44009 Boehringer Ingelheim Investigational Site
city: Leicester
country: United Kingdom
facility: 1245.33.44008 Boehringer Ingelheim Investigational Site
city: Liverpool
country: United Kingdom
facility: 1245.33.44004 Boehringer Ingelheim Investigational Site
city: Wembley
country: United Kingdom
facility: 1245.33.44007 Boehringer Ingelheim Investigational Site
city: Whitstable
country: United Kingdom
facility: 1245.33.44002 Boehringer Ingelheim Investigational Site
city: Wymondham
country: United Kingdom
facility: 1245.33.44010 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.