Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks 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:
NCT01289990
First received: January 31, 2011
Last updated: July 14, 2014
Last verified: July 2014
Results First Received: May 16, 2014  
Study Type: Interventional
Study Design: Allocation: Non-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: Placebo
Drug: Sitagliptin 100mg

  Participant Flow
  Hide Participant Flow

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
No text entered.

Reporting Groups
  Description
Empagliflozin 10 mg (Drug Naive)

Patients rolled over from trial 1245.20

Empagliflozin 10 mg tablets once daily

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching Empagliflozin 25 mg

Empagliflozin 25 mg (Drug Naive)

Patients rolled over from trial 1245.20

Empagliflozin 25 mg tablets once daily

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching Empagliflozin 10 mg

Placebo (Drug Naive)

Patients rolled over from trial 1245.20

Placebo tablets matching Empagliflozin / Sitagliptin once daily

Placebo: Placebo matching Empagliflozin 10 mg

Placebo: Placebo matching Sitagliptin

Placebo: Placebo matching Empagliflozin 25 mg

Sitagliptin 100mg (Drug Naive)

Patients rolled over from trial 1245.20

Sitagliptin once daily

Placebo: Placebo matching Empagliflozin 25 mg

Placebo: Placebo matching Empagliflozin 10 mg

Sitagliptin 100mg: Sitagliptin once daily

Empagliflozin 10 mg (Pioglitazone)

Patients rolled over from trial 1245.19

Empagliflozin 10 mg tablets once daily

Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily

Placebo: Placebo matching Empagliflozin 25 mg

Empagliflozin 25 mg (Pioglitazone)

Patients rolled over from trial 1245.19

Empagliflozin 25 mg tablets once daily

Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily

Placebo: Placebo matching Empagliflozin 10 mg

Placebo (Pioglitazone)

Patients rolled over from trial 1245.19

Placebo tablets matching Empagliflozin once daily

Placebo: Placebo matching Empagliflozin 10 mg

Placebo: Placebo matching Empagliflozin 25 mg

Empagliflozin 10 mg (Metformin)

Patients rolled over from trial 1245.23

Empagliflozin 10 mg tablets once daily

Placebo: Placebo matching Empagliflozin 25 mg

Empagliflozin 10 mg: Empagliflozin 10 mg once daily

Empagliflozin 25 mg (Metformin)

Patients rolled over from trial 1245.23

Empagliflozin 25 mg tablets once daily

Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily

Placebo: Placebo matching Empagliflozin 10 mg

Placebo (Metformin)

Patients rolled over from trial 1245.23

Placebo tablets matching Empagliflozin once daily

Placebo: Placebo matching Empagliflozin 10 mg

Placebo: Placebo matching Empagliflozin 25 mg

Empagliflozin 10 mg (Metformin+Sulfonylurea)

Patients rolled over from trial 1245.23

Empagliflozin 10 mg tablets once daily

Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily

Placebo: Placebo matching Empagliflozin 25 mg

Empagliflozin 25 mg (Metformin+Sulfonylurea)

Patients rolled over from trial 1245.23

Empagliflozin 25 mg tablets once daily

Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily

Placebo: Placebo matching Empagliflozin 10 mg

Placebo (Metformin+Sulfonylurea)

Patients rolled over from trial 1245.23

Placebo tablets matching Empagliflozin

Placebo: Placebo matching Empagliflozin 10 mg

Placebo: Placebo matching Empagliflozin 25 mg


Participant Flow:   Overall Study
    Empagliflozin 10 mg (Drug Naive)     Empagliflozin 25 mg (Drug Naive)     Placebo (Drug Naive)     Sitagliptin 100mg (Drug Naive)     Empagliflozin 10 mg (Pioglitazone)     Empagliflozin 25 mg (Pioglitazone)     Placebo (Pioglitazone)     Empagliflozin 10 mg (Metformin)     Empagliflozin 25 mg (Metformin)     Placebo (Metformin)     Empagliflozin 10 mg (Metformin+Sulfonylurea)     Empagliflozin 25 mg (Metformin+Sulfonylurea)     Placebo (Metformin+Sulfonylurea)  
STARTED     224     224     228     223     165     168     166     217     214     207     226     218     225  
COMPLETED     147     143     119     136     93     94     78     162     139     121     150     150     127  
NOT COMPLETED     77     81     109     87     72     74     88     55     75     86     76     68     98  
Death                 0                 0                 0                 1                 2                 1                 0                 0                 0                 0                 0                 1                 0  
Lost to Follow-up                 3                 2                 5                 5                 3                 4                 2                 2                 1                 4                 2                 1                 2  
Withdrawal by Subject                 15                 14                 12                 13                 8                 7                 13                 9                 12                 13                 11                 13                 16  
discontinued in preceding trial                 18                 20                 41                 17                 11                 12                 18                 8                 17                 21                 17                 17                 24  
did not continue in extension                 41                 45                 51                 51                 48                 50                 54                 36                 44                 48                 45                 34                 56  
Not treated                 0                 0                 0                 0                 0                 0                 1                 0                 1                 0                 1                 2                 0  



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment   [ Time Frame: Baseline and 52 weeks ]

2.  Primary:   Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment   [ Time Frame: Baseline and 76 weeks ]

3.  Secondary:   HbA1c (%) Changes From Baseline After 76 Weeks of Treatment   [ Time Frame: Baseline and 76 weeks ]

4.  Secondary:   Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment   [ Time Frame: Baseline and 52 weeks ]

5.  Secondary:   Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment   [ Time Frame: Baseline and 76 weeks ]

6.  Secondary:   Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment   [ Time Frame: Baseline and 52 weeks ]

7.  Secondary:   Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment   [ Time Frame: Baseline and 76 weeks ]

8.  Secondary:   Body Weight (kg) Change From Baseline After 52 Weeks of Treatment   [ Time Frame: Baseline and 52 weeks ]

9.  Secondary:   Body Weight (kg) Change From Baseline After 76 Weeks of Treatment   [ Time Frame: Baseline and 76 weeks ]

10.  Secondary:   Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment   [ Time Frame: Baseline and 52 weeks ]

11.  Secondary:   Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment   [ Time Frame: Baseline and 76 weeks ]

12.  Secondary:   Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment   [ Time Frame: Baseline and 52 weeks ]

13.  Secondary:   Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment   [ Time Frame: Baseline and 76 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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.rdf@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01289990     History of Changes
Other Study ID Numbers: 1245.31, 2010-022718-17
Study First Received: January 31, 2011
Results First Received: May 16, 2014
Last Updated: July 14, 2014
Health Authority: Belgium: Federal Agency for Medicinal and Health Products
Canada: Health Canada
China: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
India: Drugs Controller General of India
Ireland: Irish Medicines Board
Japan: Ministry of Health, Labor and Welfare
Mexico: Federal Commission for Sanitary Risks Protection
Philippines: Department of Health
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
South Korea: Ministry of Food and Drug Safety (MFDS)
Switzerland: Swissmedic
Taiwan:
Turkey: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
United States: Food and Drug Administration