Trial Outcomes & Findings for A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy (NCT NCT01649297)
NCT ID: NCT01649297
Last Updated: 2015-07-23
Results Overview
Change from baseline in HbA1c (%) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication. Means provided are the adjusted means.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
983 participants
Primary outcome timeframe
Baseline and 16 weeks
Results posted on
2015-07-23
Participant Flow
Participant milestones
| Measure |
Empa 12.5mg BID
Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
|
Empa 25mg QD
Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
|
Empa 5mg BID
Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
|
Empa 10mg QD
Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
|
Placebo
Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
219
|
218
|
219
|
220
|
107
|
|
Overall Study
COMPLETED
|
205
|
205
|
202
|
201
|
103
|
|
Overall Study
NOT COMPLETED
|
14
|
13
|
17
|
19
|
4
|
Reasons for withdrawal
| Measure |
Empa 12.5mg BID
Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
|
Empa 25mg QD
Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
|
Empa 5mg BID
Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
|
Empa 10mg QD
Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
|
Placebo
Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
5
|
4
|
13
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Non compliant with Protocol
|
1
|
0
|
3
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
4
|
3
|
0
|
|
Overall Study
Patient withdrawal (not due to AE)
|
3
|
6
|
4
|
1
|
1
|
|
Overall Study
For other reason
|
4
|
1
|
2
|
0
|
0
|
Baseline Characteristics
A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy
Baseline characteristics by cohort
| Measure |
Empa 12.5mg BID
n=215 Participants
Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
|
Empa 25mg QD
n=214 Participants
Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
|
Empa 5mg BID
n=215 Participants
Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
|
Empa 10mg QD
n=214 Participants
Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
|
Placebo
n=107 Participants
Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
|
Total
n=965 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
58.8 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
57.9 years
STANDARD_DEVIATION 11.2 • n=21 Participants
|
58.2 years
STANDARD_DEVIATION 10.3 • n=8 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
445 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
520 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and 16 weeksPopulation: Full Analysis Set (FAS) is the basis for the intention-to-treat analysis. FAS with last observation carried forward (LOCF) imputation is used as the primary method of accounting for missing data. Values after the patient started rescue medication were excluded from analysis (and imputed with an LOCF procedure).
Change from baseline in HbA1c (%) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication. Means provided are the adjusted means.
Outcome measures
| Measure |
Empa 12.5mg BID
n=215 Participants
Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
|
Empa 25mg QD
n=214 Participants
Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
|
Empa 5mg BID
n=215 Participants
Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
|
Empa 10mg QD
n=213 Participants
Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
|
Placebo
n=107 Participants
Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
|
|---|---|---|---|---|---|
|
HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16
|
-0.83 percentage of HbA1c
Standard Error 0.05
|
-0.72 percentage of HbA1c
Standard Error 0.05
|
-0.66 percentage of HbA1c
Standard Error 0.05
|
-0.64 percentage of HbA1c
Standard Error 0.05
|
-0.22 percentage of HbA1c
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: FAS with LOCF has been used for FPG analyses
Change from baseline in FPG (mg/dL) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication. Means provided are the adjusted means.
Outcome measures
| Measure |
Empa 12.5mg BID
n=213 Participants
Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
|
Empa 25mg QD
n=214 Participants
Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
|
Empa 5mg BID
n=213 Participants
Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
|
Empa 10mg QD
n=213 Participants
Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
|
Placebo
n=107 Participants
Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
|
|---|---|---|---|---|---|
|
Fasting Plasma Glucose (FPG) Change From Baseline at Week 16
|
-27.7 mg/dL
Standard Error 2.0
|
-22.7 mg/dL
Standard Error 2.0
|
-21.2 mg/dL
Standard Error 2.0
|
-17.6 mg/dL
Standard Error 2.0
|
-0.2 mg/dL
Standard Error 2.8
|
Adverse Events
Empa 12.5mg BID
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Empa 25mg QD
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Empa 5mg BID
Serious events: 7 serious events
Other events: 8 other events
Deaths: 0 deaths
Empa 10mg QD
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Empa 12.5mg BID
n=219 participants at risk
Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
|
Empa 25mg QD
n=218 participants at risk
Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
|
Empa 5mg BID
n=219 participants at risk
Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
|
Empa 10mg QD
n=220 participants at risk
Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
|
Placebo
n=107 participants at risk
Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
|
|---|---|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.46%
1/218 • 16 weeks + 1 week follow-up
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/218 • 16 weeks + 1 week follow-up
|
0.46%
1/219 • 16 weeks + 1 week follow-up
|
0.00%
0/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Biliary adenoma
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/218 • 16 weeks + 1 week follow-up
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.45%
1/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/218 • 16 weeks + 1 week follow-up
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.45%
1/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/218 • 16 weeks + 1 week follow-up
|
0.46%
1/219 • 16 weeks + 1 week follow-up
|
0.00%
0/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.46%
1/219 • 16 weeks + 1 week follow-up
|
0.00%
0/218 • 16 weeks + 1 week follow-up
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/218 • 16 weeks + 1 week follow-up
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/220 • 16 weeks + 1 week follow-up
|
0.93%
1/107 • 16 weeks + 1 week follow-up
|
|
Nervous system disorders
Ischaemic stroke
|
0.46%
1/219 • 16 weeks + 1 week follow-up
|
0.00%
0/218 • 16 weeks + 1 week follow-up
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
|
Nervous system disorders
Transient ischaemic attack
|
0.46%
1/219 • 16 weeks + 1 week follow-up
|
0.00%
0/218 • 16 weeks + 1 week follow-up
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
|
Eye disorders
Macular degeneration
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.46%
1/218 • 16 weeks + 1 week follow-up
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/218 • 16 weeks + 1 week follow-up
|
0.46%
1/219 • 16 weeks + 1 week follow-up
|
0.00%
0/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/218 • 16 weeks + 1 week follow-up
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.45%
1/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/218 • 16 weeks + 1 week follow-up
|
0.46%
1/219 • 16 weeks + 1 week follow-up
|
0.45%
1/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.46%
1/219 • 16 weeks + 1 week follow-up
|
0.00%
0/218 • 16 weeks + 1 week follow-up
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.46%
1/219 • 16 weeks + 1 week follow-up
|
0.00%
0/218 • 16 weeks + 1 week follow-up
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
|
Gastrointestinal disorders
Salivary gland pain
|
0.46%
1/219 • 16 weeks + 1 week follow-up
|
0.00%
0/218 • 16 weeks + 1 week follow-up
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/218 • 16 weeks + 1 week follow-up
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.45%
1/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/218 • 16 weeks + 1 week follow-up
|
0.46%
1/219 • 16 weeks + 1 week follow-up
|
0.00%
0/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/218 • 16 weeks + 1 week follow-up
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.45%
1/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/218 • 16 weeks + 1 week follow-up
|
0.46%
1/219 • 16 weeks + 1 week follow-up
|
0.00%
0/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.46%
1/219 • 16 weeks + 1 week follow-up
|
0.00%
0/218 • 16 weeks + 1 week follow-up
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
|
Musculoskeletal and connective tissue disorders
Exostosis of jaw
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/218 • 16 weeks + 1 week follow-up
|
0.46%
1/219 • 16 weeks + 1 week follow-up
|
0.00%
0/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/218 • 16 weeks + 1 week follow-up
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.45%
1/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/218 • 16 weeks + 1 week follow-up
|
0.46%
1/219 • 16 weeks + 1 week follow-up
|
0.00%
0/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/219 • 16 weeks + 1 week follow-up
|
0.00%
0/218 • 16 weeks + 1 week follow-up
|
0.46%
1/219 • 16 weeks + 1 week follow-up
|
0.00%
0/220 • 16 weeks + 1 week follow-up
|
0.00%
0/107 • 16 weeks + 1 week follow-up
|
Other adverse events
| Measure |
Empa 12.5mg BID
n=219 participants at risk
Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
|
Empa 25mg QD
n=218 participants at risk
Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
|
Empa 5mg BID
n=219 participants at risk
Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
|
Empa 10mg QD
n=220 participants at risk
Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
|
Placebo
n=107 participants at risk
Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
|
|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
4.6%
10/219 • 16 weeks + 1 week follow-up
|
4.6%
10/218 • 16 weeks + 1 week follow-up
|
3.7%
8/219 • 16 weeks + 1 week follow-up
|
6.8%
15/220 • 16 weeks + 1 week follow-up
|
3.7%
4/107 • 16 weeks + 1 week follow-up
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER