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

This study has been completed.
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 28, 2016
Last verified: July 2016
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
An optional 2-year extension was implemented in this trial through a protocol amendment, which brought the total length of treatment to 4 years. However, some sites did not participate in the 2-year extension, and so considered patients to have completed treatment after 2 years.

Reporting Groups
  Description
Empaglifozin 25 mg

Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.

Empagliflozin: 25 mg once daily

Placebo: Placebo matching Glimepiride

Glimepiride

Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.

Glimepiride: 1-4 mg once daily

Placebo: Placebo matching Empagliflozin


Participant Flow:   Overall Study
    Empaglifozin 25 mg   Glimepiride
STARTED   769   780 
Completed After 2 Years Treatment   95   127 
Completed After 4 Years Treatment   515   462 
COMPLETED   610   589 
NOT COMPLETED   159   191 
Adverse Event                47                51 
Lack of Efficacy                4                7 
Non compliant with protocol                9                18 
Lost to Follow-up                19                20 
Patient refusal to cont., not due to AE                45                40 
Not treated                4                0 
Other not defined above                31                55 



  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 received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.

Empagliflozin: 25 mg once daily

Placebo: Placebo matching Glimepiride

Glimepiride

Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally 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 
Overall Participants Analyzed 
[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
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Time Frame Up to 4 years.
Additional Description All adverse events (AE), serious and non-serious, occurring during the course of the clinical trial were collected, documented, and reported to the sponsor by the investigator on the appropriate case report form (CRF) or serious adverse event (SAE) reporting forms.

Frequency Threshold
Threshold above which other adverse events are reported   5  

Reporting Groups
  Description
Empa 25mg Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride
Glimepiride Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin

Other Adverse Events
    Empa 25mg   Glimepiride
Total, other (not including serious) adverse events     
# participants affected / at risk   580/765 (75.82%)   637/780 (81.67%) 
Gastrointestinal disorders     
Diarrhoea † 1     
# participants affected / at risk   62/765 (8.10%)   67/780 (8.59%) 
Infections and infestations     
Urinary tract infection † 1     
# participants affected / at risk   137/765 (17.91%)   121/780 (15.51%) 
Nasopharyngitis † 1     
# participants affected / at risk   90/765 (11.76%)   106/780 (13.59%) 
Upper respiratory tract infection † 1     
# participants affected / at risk   103/765 (13.46%)   97/780 (12.44%) 
Influenza † 1     
# participants affected / at risk   71/765 (9.28%)   73/780 (9.36%) 
Bronchitis † 1     
# participants affected / at risk   34/765 (4.44%)   64/780 (8.21%) 
Gastroenteritis † 1     
# participants affected / at risk   38/765 (4.97%)   47/780 (6.03%) 
Pharyngitis † 1     
# participants affected / at risk   42/765 (5.49%)   44/780 (5.64%) 
Metabolism and nutrition disorders     
Hypoglycaemia † 1     
# participants affected / at risk   41/765 (5.36%)   228/780 (29.23%) 
Hyperglycaemia † 1     
# participants affected / at risk   152/765 (19.87%)   227/780 (29.10%) 
Dyslipidaemia † 1     
# participants affected / at risk   51/765 (6.67%)   48/780 (6.15%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1     
# participants affected / at risk   93/765 (12.16%)   90/780 (11.54%) 
Arthralgia † 1     
# participants affected / at risk   70/765 (9.15%)   86/780 (11.03%) 
Pain in extremity † 1     
# participants affected / at risk   51/765 (6.67%)   50/780 (6.41%) 
Musculoskeletal pain † 1     
# participants affected / at risk   43/765 (5.62%)   43/780 (5.51%) 
Osteoarthritis † 1     
# participants affected / at risk   23/765 (3.01%)   41/780 (5.26%) 
Nervous system disorders     
Headache † 1     
# participants affected / at risk   59/765 (7.71%)   68/780 (8.72%) 
Dizziness † 1     
# participants affected / at risk   62/765 (8.10%)   67/780 (8.59%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1     
# participants affected / at risk   53/765 (6.93%)   62/780 (7.95%) 
Vascular disorders     
Hypertension † 1     
# participants affected / at risk   55/765 (7.19%)   105/780 (13.46%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 18.0



  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
It should be noted that not all patients were followed up for 4 years with regard to the frequencies of adverse events presented up to 4 years.


  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
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01167881     History of Changes
Other Study ID Numbers: 1245.28
2009-016244-39 ( EudraCT Number: EudraCT )
Study First Received: July 15, 2010
Results First Received: July 17, 2014
Last Updated: July 28, 2016
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