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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01167881
First received: July 15, 2010
Last updated: July 17, 2014
Last verified: July 2014
Results First Received: July 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: BI 10773
Drug: Glimepiride
Drug: Placebo

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), All patients randomised, treated with at least one dose of study drug, and with a baseline HbA1c value.

Reporting Groups
  Description
Empaglifozin 25 mg

Patients receive one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule once daily

Empagliflozin: 25 mg once daily

Placebo: Placebo matching Glimepiride

Glimepiride

Patients receive one Glimepiride capsule and one placebo Empagliflozin tablet once daily.

Glimepiride: 1-4 mg once daily

Placebo: Placebo matching Empagliflozin

Total Total of all reporting groups

Baseline Measures
    Empaglifozin 25 mg     Glimepiride     Total  
Number of Participants  
[units: participants]
  765     780     1545  
Age  
[units: years]
Mean ± Standard Deviation
  56.2  ± 10.3     55.7  ± 10.4     55.9  ± 10.4  
Gender  
[units: participants]
     
Female     333     359     692  
Male     432     421     853  



  Outcome Measures
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1.  Primary:   The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.   [ Time Frame: Baseline and 104 weeks ]

2.  Secondary:   The Change in Body Weight From Baseline After 104 Weeks of Treatment.   [ Time Frame: baseline and 104 weeks ]

3.  Secondary:   The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment.   [ Time Frame: baseline and 104 weeks ]

4.  Secondary:   The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment.   [ Time Frame: baseline and 104 weeks ]

5.  Secondary:   The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment.   [ Time Frame: baseline and 104 weeks ]

6.  Secondary:   The Change From Baseline in HbA1c After 52 Weeks of Treatment.   [ Time Frame: baseline and 52 weeks ]

7.  Secondary:   The Change in Body Weight From Baseline After 52 Weeks of Treatment.   [ Time Frame: baseline and 52 weeks ]

8.  Secondary:   The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment.   [ Time Frame: baseline and 52 weeks ]

9.  Secondary:   The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment.   [ Time Frame: baseline and 52 weeks ]

10.  Secondary:   The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment.   [ Time Frame: baseline and 52 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided by Boehringer Ingelheim

Publications automatically indexed to this study:

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01167881     History of Changes
Other Study ID Numbers: 1245.28, 2009-016244-39
Study First Received: July 15, 2010
Results First Received: July 17, 2014
Last Updated: July 17, 2014
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Austria: Medicines and Medical Devices Agency
Canada: Health Canada
Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
Hong Kong: Department of Health
India: Drugs Controller General of India
Italy: Ethics Committee
Malaysia: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: Central Committee Research Involving Human Subjects
Norway: Norwegian Medicines Agency
Philippines: Bureau of Food and Drugs
Portugal: National Pharmacy and Medicines Institute
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
Taiwan : Food and Drug Administration
Thailand: Ministry of Public Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration