Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg and 25 mg Administered Once Daily) as Add on to Pre-existing Antidiabetic Therapy Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Renal Impairment and Insufficient Glycaemic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01164501
• Other study ID #: 1245.36
• Secondary ID: 2009-016179-31
• Status: Completed
• Phase: Phase 3
• First received: July 15, 2010
• Last updated: May 16, 2014
• Start date: July 2010
• Est. completion date: July 2012

Study information

• Verified date: May 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Hong Kong: Department of HealthIndia: Drugs Controller General of IndiaMalaysia: Ministry of HealthNetherlands: Central Committee Research Involving Human SubjectsPhilippines: Bureau of Food and DrugsPoland: Registration Medicinal Product Medical Device Biocidal ProductPortugal: National Pharmacy and Medicines InstituteRussia: Pharmacological Committee, Ministry of HealthSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilSpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will investigate the efficacy and safety of the BI 10773 in type 2 diabetic patients with renal impairment in order to provide these data for approval for BI 10773 as an antidiabetic agent by regulatory authorities.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 741
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Diagnosis of type 2 diabetes mellitus prior to informed consent and an estimated glomerular filtration rate of <90 ml/min.

2. Male and female patients on diet and exercise regimen who are pre-treated with any antidiabetic therapy and are on the maximum tolerated dose which has been unchanged for 12 weeks prior to randomisation.

3. HbA1c greater than or equal to 7.0% and less than or equal to 10.0% .

4. Aged 18 years or above.

5. Body Mass Index less than or equal to 45 kg/m2

Exclusion criteria:

1. Uncontrolled hyperglycaemia defined as >13.3 mmol/L after an overnight fast during placebo run-in.

2. Impaired renal function, defined as an estimated glomerular filtration rate <15 ml/min.

3. Renal impairment requiring any form of chronic dialysis.

4. Requiring acute dialysis within three months prior to informed consent.

5. Renal transplant recipient.

6. Myocardial infarction, stroke or Transient Ischemic Attack within three months prior to informed consent.

7. Indication of liver disease.

8. Bariatric surgery within the past two years.

9. Medical history of cancer.

10. Blood dyscrasias or any disorders causing hemolysis or unstable red blood cell.

11. Contraindications to pre-existing background antidiabetic therapy.

12. Treatment with anti-obesity drugs.

13. Current treatment with systemic steroids or change in dosage of thyroid hormones within six weeks prior to informed consent or any other uncontrolled endocrine disorder except Type 2 Diabetes.

14. Pre-menopausal women who are nursing or pregnant or are of child-bearing potential and are not practising an acceptable method of birth control.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Renal Insufficiency

Intervention

Drug:
• BI 10773
BI 10773 tablets once daily
• Placebo
Placebo tablets identical to BI 10773 low dose
• Placebo
Placebo tablets identical to BI 10773 high dose
• BI 10773
BI 10773 tablets once daily
• Placebo
Placebo tablets identical to BI 10773 low dose
• Placebo
Placebo tablets identical to BI 10773 high dose

Locations

Country	Name	City	State
Canada	1245.36.20052 Boehringer Ingelheim Investigational Site	Calgary	Alberta
Canada	1245.36.20054 Boehringer Ingelheim Investigational Site	Calgary	Alberta
Canada	1245.36.20023 Boehringer Ingelheim Investigational Site	Edmonton	Alberta
Canada	1245.36.20055 Boehringer Ingelheim Investigational Site	Edmonton	Alberta
Canada	1245.36.20051 Boehringer Ingelheim Investigational Site	Mississauga	Ontario
Canada	1245.36.20056 Boehringer Ingelheim Investigational Site	Montreal	Quebec
Canada	1245.36.20086 Boehringer Ingelheim Investigational Site	Thornhill	Ontario
Canada	1245.36.20053 Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	1245.36.20048 Boehringer Ingelheim Investigational Site	Winnipeg	Manitoba
France	1245.36.33001 Boehringer Ingelheim Investigational Site	Corbeil Essonnes
France	1245.36.33042 Boehringer Ingelheim Investigational Site	Nanterre Cedex
France	1245.36.33041 Boehringer Ingelheim Investigational Site	Nice
France	1245.36.33036 Boehringer Ingelheim Investigational Site	Paris
France	1245.36.33040 Boehringer Ingelheim Investigational Site	Poitiers
France	1245.36.33037 Boehringer Ingelheim Investigational Site	Reims
France	1245.36.33038 Boehringer Ingelheim Investigational Site	Reims Cedex
France	1245.36.33043 Boehringer Ingelheim Investigational Site	Rennes
France	1245.36.33044 Boehringer Ingelheim Investigational Site	Saint Mandé
Hong Kong	1245.36.85201 Boehringer Ingelheim Investigational Site	Hong Kong
Hong Kong	1245.36.85204 Boehringer Ingelheim Investigational Site	Hong Kong
Hong Kong	1245.36.85205 Boehringer Ingelheim Investigational Site	Hong Kong
Hong Kong	1245.36.85206 Boehringer Ingelheim Investigational Site	Hong Kong
Hong Kong	1245.36.85202 Boehringer Ingelheim Investigational Site	Kowloon
India	1245.36.91209 Boehringer Ingelheim Investigational Site	Aligarh, Uttar Pradesh
India	1245.36.91202 Boehringer Ingelheim Investigational Site	Bangalore
India	1245.36.91204 Boehringer Ingelheim Investigational Site	Bangalore
India	1245.36.91205 Boehringer Ingelheim Investigational Site	Bangalore
India	1245.36.91208 Boehringer Ingelheim Investigational Site	Bangalore
India	1245.36.91201 Boehringer Ingelheim Investigational Site	Chennai
India	1245.36.91214 Boehringer Ingelheim Investigational Site	Chennai
India	1245.36.91213 Boehringer Ingelheim Investigational Site	Gurgaon
India	1245.36.91203 Boehringer Ingelheim Investigational Site	Hyderabad
India	1245.36.91211 Boehringer Ingelheim Investigational Site	Kolkata
India	1245.36.91210 Boehringer Ingelheim Investigational Site	Mangalore
India	1245.36.91215 Boehringer Ingelheim Investigational Site	Mumbai, Maharastra
India	1245.36.91216 Boehringer Ingelheim Investigational Site	Nasik
India	1245.36.91212 Boehringer Ingelheim Investigational Site	New Delhi
India	1245.36.91207 Boehringer Ingelheim Investigational Site	Pune
Malaysia	1245.36.60003 Boehringer Ingelheim Investigational Site	Johor Baru
Malaysia	1245.36.60006 Boehringer Ingelheim Investigational Site	Kelantan Kota Bahru
Malaysia	1245.36.60005 Boehringer Ingelheim Investigational Site	Kuala Lumpur
Malaysia	1245.36.60009 Boehringer Ingelheim Investigational Site	Kuala Lumpur
Malaysia	1245.36.60004 Boehringer Ingelheim Investigational Site	Pahang
Malaysia	1245.36.60007 Boehringer Ingelheim Investigational Site	Perak
Malaysia	1245.36.60011 Boehringer Ingelheim Investigational Site	Perak
Malaysia	1245.36.60010 Boehringer Ingelheim Investigational Site	Pulau Piang
Malaysia	1245.36.60008 Boehringer Ingelheim Investigational Site	Sabah
Malaysia	1245.36.60001 Boehringer Ingelheim Investigational Site	Selangor Darul Ehsan
Netherlands	1245.36.31015 Boehringer Ingelheim Investigational Site	Amersfoort
Netherlands	1245.36.31004 Boehringer Ingelheim Investigational Site	Den Haag
Netherlands	1245.36.31012 Boehringer Ingelheim Investigational Site	Geleen
Netherlands	1245.36.31017 Boehringer Ingelheim Investigational Site	Hardenberg
Netherlands	1245.36.31009 Boehringer Ingelheim Investigational Site	Maastricht
Netherlands	1245.36.31002 Boehringer Ingelheim Investigational Site	Utrecht
Netherlands	1245.36.31003 Boehringer Ingelheim Investigational Site	Zaandam
Philippines	1245.36.63008 Boehringer Ingelheim Investigational Site	Cavite City
Philippines	1245.36.63006 Boehringer Ingelheim Investigational Site	Cebu
Philippines	1245.36.63005 Boehringer Ingelheim Investigational Site	Manila
Philippines	1245.36.63007 Boehringer Ingelheim Investigational Site	Manila
Philippines	1245.36.63009 Boehringer Ingelheim Investigational Site	Marikina
Philippines	1245.36.63010 Boehringer Ingelheim Investigational Site	Tacloban
Poland	1245.36.48006 Boehringer Ingelheim Investigational Site	Gdansk
Poland	1245.36.48003 Boehringer Ingelheim Investigational Site	Lodz
Poland	1245.36.48004 Boehringer Ingelheim Investigational Site	Lodz
Poland	1245.36.48001 Boehringer Ingelheim Investigational Site	Lublin
Poland	1245.36.48002 Boehringer Ingelheim Investigational Site	Poznan
Poland	1245.36.48007 Boehringer Ingelheim Investigational Site	Ruda Slaska
Poland	1245.36.48005 Boehringer Ingelheim Investigational Site	Torun
Portugal	1245.36.35003 Boehringer Ingelheim Investigational Site	Faro
Portugal	1245.36.35002 Boehringer Ingelheim Investigational Site	Lisboa
Portugal	1245.36.35004 Boehringer Ingelheim Investigational Site	Lisboa
Portugal	1245.36.35001 Boehringer Ingelheim Investigational Site	Vila Nova de Gaia
Russian Federation	1245.36.70008 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1245.36.70009 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1245.36.70011 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1245.36.70004 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1245.36.70006 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1245.36.70002 Boehringer Ingelheim Investigational Site	Vsevolozhsk
Slovakia	1245.36.74011 Boehringer Ingelheim Investigational Site	Moldava nad Bodvou
Slovakia	1245.36.74013 Boehringer Ingelheim Investigational Site	Nitra
Slovakia	1245.36.74008 Boehringer Ingelheim Investigational Site	Nove Mesto Nad Vahom
Slovakia	1245.36.74012 Boehringer Ingelheim Investigational Site	Presov
Slovakia	1245.36.74007 Boehringer Ingelheim Investigational Site	Trencin
Slovakia	1245.36.74009 Boehringer Ingelheim Investigational Site	Zilina
South Africa	1245.36.76021 Boehringer Ingelheim Investigational Site	Plumstead
South Africa	1245.36.76020 Boehringer Ingelheim Investigational Site	Somerset West
South Africa	1245.36.76022 Boehringer Ingelheim Investigational Site	Somerset West
Spain	1245.36.34015 Boehringer Ingelheim Investigational Site	Barcelona
Spain	1245.36.34009 Boehringer Ingelheim Investigational Site	Granada
Spain	1245.36.34014 Boehringer Ingelheim Investigational Site	L'Hospitalet de Llobregat
Spain	1245.36.34012 Boehringer Ingelheim Investigational Site	Madrid
Spain	1245.36.34013 Boehringer Ingelheim Investigational Site	Madrid
Spain	1245.36.34020 Boehringer Ingelheim Investigational Site	Manresa
Spain	1245.36.34021 Boehringer Ingelheim Investigational Site	San Sebastian de los Reyes
Spain	1245.36.34016 Boehringer Ingelheim Investigational Site	Santiago de Compostela
Spain	1245.36.34017 Boehringer Ingelheim Investigational Site	Valencia
Spain	1245.36.34019 Boehringer Ingelheim Investigational Site	Valencia
United Kingdom	1245.36.44018 Boehringer Ingelheim Investigational Site	Bath
United Kingdom	1245.36.44010 Boehringer Ingelheim Investigational Site	Birmingham
United Kingdom	1245.36.44013 Boehringer Ingelheim Investigational Site	Blackpool
United Kingdom	1245.36.44016 Boehringer Ingelheim Investigational Site	Blackpool
United Kingdom	1245.36.44026 Boehringer Ingelheim Investigational Site	Chester
United Kingdom	1245.36.44012 Boehringer Ingelheim Investigational Site	Chesterfield
United Kingdom	1245.36.44025 Boehringer Ingelheim Investigational Site	Doncaster
United Kingdom	1245.36.44036 Boehringer Ingelheim Investigational Site	Epsom
United Kingdom	1245.36.44001 Boehringer Ingelheim Investigational Site	Frome
United Kingdom	1245.36.44007 Boehringer Ingelheim Investigational Site	Midsomer Norton
United Kingdom	1245.36.44023 Boehringer Ingelheim Investigational Site	Nantwich
United Kingdom	1245.36.44024 Boehringer Ingelheim Investigational Site	Welwyn Garden City
United States	1245.36.10014 Boehringer Ingelheim Investigational Site	Anaheim	California
United States	1245.36.10005 Boehringer Ingelheim Investigational Site	Bethlehem	Pennsylvania
United States	1245.36.10012 Boehringer Ingelheim Investigational Site	Corpus Christi	Texas
United States	1245.36.10013 Boehringer Ingelheim Investigational Site	Dallas	Texas
United States	1245.36.10021 Boehringer Ingelheim Investigational Site	Endwell	New York
United States	1245.36.10008 Boehringer Ingelheim Investigational Site	Greenville	North Carolina
United States	1245.36.10004 Boehringer Ingelheim Investigational Site	Greer	South Carolina
United States	1245.36.10018 Boehringer Ingelheim Investigational Site	Honolulu	Hawaii
United States	1245.36.10002 Boehringer Ingelheim Investigational Site	Houston	Texas
United States	1245.36.10019 Boehringer Ingelheim Investigational Site	Lomita	California
United States	1245.36.10003 Boehringer Ingelheim Investigational Site	Melrose Park	Pennsylvania
United States	1245.36.10017 Boehringer Ingelheim Investigational Site	Plantation	Florida
United States	1245.36.10023 Boehringer Ingelheim Investigational Site	Renton	Washington
United States	1245.36.10007 Boehringer Ingelheim Investigational Site	San Antonio	Texas
United States	1245.36.10015 Boehringer Ingelheim Investigational Site	Shreveport	Louisiana
United States	1245.36.10011 Boehringer Ingelheim Investigational Site	Spokane	Washington
United States	1245.36.10006 Boehringer Ingelheim Investigational Site	Tacoma	Washington
United States	1245.36.10009 Boehringer Ingelheim Investigational Site	West Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Canada,  France,  Hong Kong,  India,  Malaysia,  Netherlands,  Philippines,  Poland,  Portugal,  Russian Federation,  Slovakia,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hypoglycaemic Events	Percentage of patients who experienced a hypoglycaemic event. A hypoglycaemic event was regarded as confirmed if it was documented as an adverse event with plasma glucose values <= 70 mg/dL (<=3.9mmol/L) measured or with a documentation that the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative action had been required.	From first drug administration until 7 days after last trial medication intake, up to 458 days	No
Primary	HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment	Change from baseline in HbA1c after 24 weeks, for patients with mild or moderate renal impairment.; Note adjusted means are provided.	Baseline and 24 weeks	No
Primary	HbA1c Change From Baseline in Patients With Mild Renal Impairment	Change from baseline in HbA1c after 24 weeks, for patients with mild renal impairment.; Note adjusted means are provided.	Baseline and 24 weeks	No
Primary	HbA1c Change From Baseline in Patients With Moderate Renal Impairment	Change from baseline in HbA1c after 24 weeks, for patients with moderate renal impairment.; Note adjusted means are provided.	Baseline and 24 weeks	No

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