Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01368081
• Collaborator: Eli Lilly and Company (Industry)
• Enrollment: 1,162
• Locations: 87
• Arms: 3
• Duration (Months): 23
• Patients Per Site: 13.4
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The objective of the study is to investigate the long-term safety and efficacy of BI 10773 given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Metformin; Drug: BI 10773; Drug: Placebo (low dose); Drug: BI 10773; Drug: Placebo (high dose)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1162 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A 52-week, Randomised, Multi-centre, Parallel Group Study to Investigate the Safety and Efficacy of BI 10773 (10 mg or 25 mg Administered Orally Once Daily) as add-on Therapy to an Oral Antidiabetic Drug (Sulfonylurea, Biguanide, Thiazolidinedione, Alpha Glucosidase Inhibitor, DPP-IV Inhibitor, or Glinide) in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BI 10773 low dose BI 10773 low dose tablet once daily	Drug: BI 10773; BI 10773 low dose tablet once daily; Drug: Placebo (high dose); Placebo tablets once daily
Experimental: BI 10773 high dose BI 10773 high dose tablet once daily	Drug: Placebo (low dose); Placebo tablets once daily; Drug: BI 10773; BI 10773 high dose tablet once daily
Active Comparator: Metformin Metformin tablets 500-2250 mg a day (twice or three times per day)	Drug: Metformin; Metformin tablets 500-2250 mg a day (twice or three times per day)

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Drug Related Adverse Events [After the first drug intake until 7 days after the last treatment administration, up to 383 days]

   Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days

Secondary Outcome Measures

1. Change From Baseline in HbA1c [Baseline and 52 weeks]

   Change from baseline in HbA1c after 52 weeks of treatment

Other Outcome Measures

1. Confirmed Hypoglycaemic Adverse Events [After the first drug intake until 7 days after the last treatment administration, up to 383 days]

   Number of patients with confirmed hypoglycaemic adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• .Diagnosis of type 2 diabetes mellitus prior to informed consent

• Male and female patients, on diet and exercise regimen, who are pre-treated with one of the following oral antidiabetic drugs: sulfonylurea, glinide, biguanide, Alpha-glucosidase inhibitor (a-GI), dipeptidyl peptidase-IV (DPP-IV) inhibitor or thiazolidinedione

• glycosylated haemoglobin (HbA1c) at Visit 1: >=7.0 to =<10.0% (national glycohemoglobin standardization program)

Exclusion criteria:

• Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L)

• Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent

• Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1245.52.023 Boehringer Ingelheim Investigational Site	Adachi-ku, Tokyo		Japan
2	1245.52.048 Boehringer Ingelheim Investigational Site	Aki-gun, Hiroshima		Japan
3	1245.52.012 Boehringer Ingelheim Investigational Site	Annaka, Gunma		Japan
4	1245.52.087 Boehringer Ingelheim Investigational Site	Atami, Shizuoka		Japan
5	1245.52.008 Boehringer Ingelheim Investigational Site	Beppu, Oita		Japan
6	1245.52.073 Boehringer Ingelheim Investigational Site	Chiyoda-ku, Tokyo		Japan
7	1245.52.002 Boehringer Ingelheim Investigational Site	Chuo-ku, Tokyo		Japan
8	1245.52.020 Boehringer Ingelheim Investigational Site	Chuo-ku, Tokyo		Japan
9	1245.52.021 Boehringer Ingelheim Investigational Site	Chuo-ku, Tokyo		Japan
10	1245.52.031 Boehringer Ingelheim Investigational Site	Fujisawa, Kanagawa		Japan
11	1245.52.077 Boehringer Ingelheim Investigational Site	Fukuoka, Fukuoka		Japan
12	1245.52.086 Boehringer Ingelheim Investigational Site	Hadano, Kanagawa		Japan
13	1245.52.037 Boehringer Ingelheim Investigational Site	Hamamatsu, Shizuoka		Japan
14	1245.52.046 Boehringer Ingelheim Investigational Site	Himeji, Hyogo		Japan
15	1245.52.047 Boehringer Ingelheim Investigational Site	Hiroshima, Hiroshima		Japan
16	1245.52.051 Boehringer Ingelheim Investigational Site	Imabari, Ehime		Japan
17	1245.52.016 Boehringer Ingelheim Investigational Site	Iruma,Saitama		Japan
18	1245.52.033 Boehringer Ingelheim Investigational Site	Isehara, Kanagawa		Japan
19	1245.52.011 Boehringer Ingelheim Investigational Site	Isesaki, Gunma		Japan
20	1245.52.045 Boehringer Ingelheim Investigational Site	Izumisano,Osaka		Japan
21	1245.52.088 Boehringer Ingelheim Investigational Site	Kamakura, Kanagawa		Japan
22	1245.52.072 Boehringer Ingelheim Investigational Site	Kamakura,Kanagawa		Japan
23	1245.52.034 Boehringer Ingelheim Investigational Site	Kanazawa, Ishikawa		Japan
24	1245.52.058 Boehringer Ingelheim Investigational Site	Kanoya, Kagoshima		Japan
25	1245.52.019 Boehringer Ingelheim Investigational Site	Kashiwa, Chiba		Japan
26	1245.52.039 Boehringer Ingelheim Investigational Site	Kasugai, Aichi		Japan
27	1245.52.027 Boehringer Ingelheim Investigational Site	Kawasaki, Kanagawa		Japan
28	1245.52.018 Boehringer Ingelheim Investigational Site	Kita-adachi-gun, Saitama		Japan
29	1245.52.022 Boehringer Ingelheim Investigational Site	Kita-ku, Tokyo		Japan
30	1245.52.052 Boehringer Ingelheim Investigational Site	Kitakyushu, Fukuoka		Japan
31	1245.52.076 Boehringer Ingelheim Investigational Site	Kobe, Hyogo		Japan
32	1245.52.026 Boehringer Ingelheim Investigational Site	Kodaira, Tokyo		Japan
33	1245.52.069 Boehringer Ingelheim Investigational Site	Koriyama, Fukushima		Japan
34	1245.52.071 Boehringer Ingelheim Investigational Site	Koriyama, Fukushima		Japan
35	1245.52.014 Boehringer Ingelheim Investigational Site	Koshigaya, Saitama		Japan
36	1245.52.074 Boehringer Ingelheim Investigational Site	Kuki, Saitama		Japan
37	1245.52.055 Boehringer Ingelheim Investigational Site	Kumamoto, Kumamoto		Japan
38	1245.52.049 Boehringer Ingelheim Investigational Site	Kure, Hiroshima		Japan
39	1245.52.040 Boehringer Ingelheim Investigational Site	Kyoto, Kyoto		Japan
40	1245.52.010 Boehringer Ingelheim Investigational Site	Maebashi, Gunma		Japan
41	1245.52.080 Boehringer Ingelheim Investigational Site	Maebashi, Gunma		Japan
42	1245.52.050 Boehringer Ingelheim Investigational Site	Matsuyama, Ehime		Japan
43	1245.52.075 Boehringer Ingelheim Investigational Site	Meguro-ku, Tokyo		Japan
44	1245.52.056 Boehringer Ingelheim Investigational Site	Miyazaki, Miyazaki		Japan
45	1245.52.057 Boehringer Ingelheim Investigational Site	Miyazaki, Miyazaki		Japan
46	1245.52.079 Boehringer Ingelheim Investigational Site	Morioka, Iwate		Japan
47	1245.52.003 Boehringer Ingelheim Investigational Site	Nagoya, Aichi		Japan
48	1245.52.004 Boehringer Ingelheim Investigational Site	Nagoya, Aichi		Japan
49	1245.52.005 Boehringer Ingelheim Investigational Site	Nagoya, Aichi		Japan
50	1245.52.038 Boehringer Ingelheim Investigational Site	Nagoya, Aichi		Japan
51	1245.52.059 Boehringer Ingelheim Investigational Site	Naha, Okinawa		Japan
52	1245.52.066 Boehringer Ingelheim Investigational Site	Naha, Okinawa		Japan
53	1245.52.065 Boehringer Ingelheim Investigational Site	Nanjyo, Okinawa		Japan
54	1245.52.007 Boehringer Ingelheim Investigational Site	Oita, Oita		Japan
55	1245.52.053 Boehringer Ingelheim Investigational Site	Okawa, Fukuoka		Japan
56	1245.52.068 Boehringer Ingelheim Investigational Site	Okinawa, Okinawa		Japan
57	1245.52.042 Boehringer Ingelheim Investigational Site	Osaka,Osaka		Japan
58	1245.52.089 Boehringer Ingelheim Investigational Site	Osaki, Miyagi		Japan
59	1245.52.024 Boehringer Ingelheim Investigational Site	Ota-ku, Tokyo		Japan
60	1245.52.054 Boehringer Ingelheim Investigational Site	Saga, Saga		Japan
61	1245.52.032 Boehringer Ingelheim Investigational Site	Sagamihara, Kanagawa		Japan
62	1245.52.085 Boehringer Ingelheim Investigational Site	Sagamihara, Kanagawa		Japan
63	1245.52.013 Boehringer Ingelheim Investigational Site	Saitama, Saitama		Japan
64	1245.52.015 Boehringer Ingelheim Investigational Site	Sakado, Saitama		Japan
65	1245.52.044 Boehringer Ingelheim Investigational Site	Sakai, Osaka		Japan
66	1245.52.035 Boehringer Ingelheim Investigational Site	Saku, Nagano		Japan
67	1245.52.009 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido		Japan
68	1245.52.025 Boehringer Ingelheim Investigational Site	Setagaya-ku, Tokyo		Japan
69	1245.52.063 Boehringer Ingelheim Investigational Site	Shimajiri-gun, Okinawa		Japan
70	1245.52.064 Boehringer Ingelheim Investigational Site	Shimajiri-gun, Okinawa		Japan
71	1245.52.001 Boehringer Ingelheim Investigational Site	Shinjuku-ku. Tokyo		Japan
72	1245.52.036 Boehringer Ingelheim Investigational Site	Shizuoka, Shizuoka		Japan
73	1245.52.006 Boehringer Ingelheim Investigational Site	Suita, Osaka		Japan
74	1245.52.043 Boehringer Ingelheim Investigational Site	Takatsuki, Osaka		Japan
75	1245.52.017 Boehringer Ingelheim Investigational Site	Tokorozawa, Saitama		Japan
76	1245.52.070 Boehringer Ingelheim Investigational Site	Tokorozawa, Saitama		Japan
77	1245.52.061 Boehringer Ingelheim Investigational Site	Tomigusuku, Okinawa		Japan
78	1245.52.062 Boehringer Ingelheim Investigational Site	Tomigusuku, Okinawa		Japan
79	1245.52.041 Boehringer Ingelheim Investigational Site	Uji, Kyoto		Japan
80	1245.52.067 Boehringer Ingelheim Investigational Site	Uruma, Okinawa		Japan
81	1245.52.028 Boehringer Ingelheim Investigational Site	Yokohama, Kanagawa		Japan
82	1245.52.029 Boehringer Ingelheim Investigational Site	Yokohama, Kanagawa		Japan
83	1245.52.030 Boehringer Ingelheim Investigational Site	Yokohama, Kanagawa		Japan
84	1245.52.081 Boehringer Ingelheim Investigational Site	Yokohama, Kanagawa		Japan
85	1245.52.082 Boehringer Ingelheim Investigational Site	Yokohama, Kanagawa		Japan
86	1245.52.083 Boehringer Ingelheim Investigational Site	Yokohama, Kanagawa		Japan
87	1245.52.084 Boehringer Ingelheim Investigational Site	Yokohama, Kanagawa		Japan

Sponsors and Collaborators

• Boehringer Ingelheim
• Eli Lilly and Company

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT01368081
• Other Study ID Numbers: 1245.52
• First Posted: Jun 7, 2011
• Last Update Posted: Jun 17, 2014
• Last Verified: May 1, 2014

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metformin; Empagliflozin

Study Results

Participant Flow

Arm/Group Title	Sulfonylurea: Empa 10mg	Sulfonylurea: Empa 25mg	Sulfonylurea: Metformin	Biguanide: Empa 10mg	Biguanide: Empa 25mg	Thiazolidinedione: Empa 10mg	Thiazolidinedione: Empa 25mg	Alpha Glucosidase Inhibitor: Empa 10mg	Alpha Glucosidase Inhibitor: Empa 25mg	DPP-IV Inhibitor: Empa 10mg	DPP-IV Inhibitor: Empa 25mg	Glinide: Empa 10mg	Glinide: Empa 25mg
Arm/Group Description	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea	250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of dipeptidyl peptidase IV (DPP-IV) inhibitor	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of dipeptidyl peptidase IV (DPP-IV) inhibitor	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
Period Title: Overall Study
STARTED	136	137	63	68	65	137	136	69	70	68	71	70	70
COMPLETED	126	128	59	63	63	127	124	62	62	58	62	67	63
NOT COMPLETED	10	9	4	5	2	10	12	7	8	10	9	3	7

Baseline Characteristics

Arm/Group Title	Sulfonylurea: Empa 10mg	Sulfonylurea: Empa 25mg	Sulfonylurea: Metformin	Biguanide: Empa 10mg	Biguanide: Empa 25mg	Thiazolidinedione: Empa 10mg	Thiazolidinedione: Empa 25mg	Alpha Glucosidase Inhibitor: Empa 10mg	Alpha Glucosidase Inhibitor: Empa 25mg	DPP-IV Inhibitor: Empa 10mg	DPP-IV Inhibitor: Empa 25mg	Glinide: Empa 10mg	Glinide: Empa 25mg	Total
Arm/Group Description	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea	250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide	Total of all reporting groups
Overall Participants	136	137	63	68	65	137	136	69	70	68	71	70	70	1160
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.3 (9.9)	61.8 (9.6)	60.0 (10.2)	56.9 (9.5)	57.3 (11.4)	60.4 (10.1)	59.7 (9.9)	63.5 (8.8)	61.9 (11.7)	63.3 (9.9)	59.1 (10.3)	59.2 (12.1)	57.7 (11.8)	60.3 (10.4)
Sex: Female, Male (Count of Participants)
Female	37 27.2%	41 29.9%	16 25.4%	30 44.1%	22 33.8%	23 16.8%	34 25%	18 26.1%	18 25.7%	27 39.7%	23 32.4%	23 32.9%	13 18.6%	325 28%
Male	99 72.8%	96 70.1%	47 74.6%	38 55.9%	43 66.2%	114 83.2%	102 75%	51 73.9%	52 74.3%	41 60.3%	48 67.6%	47 67.1%	57 81.4%	835 72%

Outcome Measures

1. Secondary Outcome

Title	Change From Baseline in HbA1c
Description	Change from baseline in HbA1c after 52 weeks of treatment
Time Frame	Baseline and 52 weeks

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Sulfonylurea: Empa 10mg	Sulfonylurea: Empa 25mg	Sulfonylurea: Metformin	Biguanide: Empa 10mg	Biguanide: Empa 25mg	Thiazolidinedione: Empa 10mg	Thiazolidinedione: Empa 25mg	Alpha Glucosidase Inhibitor: Empa 10mg	Alpha Glucosidase Inhibitor: Empa 25mg	DPP-IV Inhibitor: Empa 10mg	DPP-IV Inhibitor: Empa 25mg	Glinide: Empa 10mg	Glinide: Empa 25mg
Arm/Group Description	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea	250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
Measure Participants	136	137	63	68	65	137	136	69	70	68	71	70	70
Least Squares Mean (Standard Error) [percentage of HbA1c]	-0.93 (0.05)	-0.96 (0.05)	-0.97 (0.08)	-0.81 (0.06)	-0.98 (0.06)	-0.90 (0.05)	-0.96 (0.05)	-0.87 (0.06)	-0.77 (0.06)	-1.00 (0.06)	-0.83 (0.06)	-0.98 (0.08)	-0.98 (0.08)

2. Primary Outcome

Title	Number of Patients With Drug Related Adverse Events
Description	Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days
Time Frame	After the first drug intake until 7 days after the last treatment administration, up to 383 days

Outcome Measure Data

Analysis Population Description

Treated patients

Arm/Group Title	Sulfonylurea: Empa 10mg	Sulfonylurea: Empa 25mg	Sulfonylurea: Metformin	Biguanide: Empa 10mg	Biguanide: Empa 25mg	Thiazolidinedione: Empa 10mg	Thiazolidinedione: Empa 25mg	Alpha Glucosidase Inhibitor: Empa 10mg	Alpha Glucosidase Inhibitor: Empa 25mg	DPP-IV Inhibitor: Empa 10mg	DPP-IV Inhibitor: Empa 25mg	Glinide: Empa 10mg	Glinide: Empa 25mg
Arm/Group Description	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea	250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
Measure Participants	136	137	63	68	65	137	136	69	70	68	71	70	70
Number [participants]	19 14%	25 18.2%	13 20.6%	13 19.1%	9 13.8%	20 14.6%	19 14%	7 10.1%	5 7.1%	9 13.2%	18 25.4%	9 12.9%	9 12.9%

3. Other Pre-specified Outcome

Title	Confirmed Hypoglycaemic Adverse Events
Description	Number of patients with confirmed hypoglycaemic adverse events
Time Frame	After the first drug intake until 7 days after the last treatment administration, up to 383 days

Outcome Measure Data

Analysis Population Description

Treated patients

Arm/Group Title	Sulfonylurea: Empa 10mg	Sulfonylurea: Empa 25mg	Sulfonylurea: Metformin	Biguanide: Empa 10mg	Biguanide: Empa 25mg	Thiazolidinedione: Empa 10mg	Thiazolidinedione: Empa 25mg	Alpha Glucosidase Inhibitor: Empa 10mg	Alpha Glucosidase Inhibitor: Empa 25mg	DPP-IV Inhibitor: Empa 10mg	DPP-IV Inhibitor: Empa 25mg	Glinide: Empa 10mg	Glinide: Empa 25mg
Arm/Group Description	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea	250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
Measure Participants	136	137	63	68	65	137	136	69	70	68	71	70	70
Number [participants]	6 4.4%	9 6.6%	5 7.9%	0 0%	1 1.5%	2 1.5%	1 0.7%	0 0%	0 0%	0 0%	1 1.4%	0 0%	2 2.9%

Adverse Events

Time Frame	After the first drug intake until 7 days after the last treatment administration, up to 383 days
Arm/Group Title	Sulfonylurea: Empa 10mg		Sulfonylurea: Empa 25mg		Sulfonylurea: Metformin		Biguanide: Empa 10mg		Biguanide: Empa 25mg		Thiazolidinedione: Empa 10mg		Thiazolidinedione: Empa 25mg		Alpha-GI: Empa 10mg		Alpha-GI: Empa 25mg		DPP-4 Inhibitor: Empa 10mg		DPP-4 Inhibitor: Empa 25mg		Glinide: Empa 10mg		Glinide: Empa 25mg
Arm/Group Description	One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea		One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea		250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea		tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide		tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide		tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione		tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione		tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha-GI		tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha-GI		tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-4 inhibitor		tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-4 inhibitor		tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide		tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
All Cause Mortality
	Sulfonylurea: Empa 10mg		Sulfonylurea: Empa 25mg		Sulfonylurea: Metformin		Biguanide: Empa 10mg		Biguanide: Empa 25mg		Thiazolidinedione: Empa 10mg		Thiazolidinedione: Empa 25mg		Alpha-GI: Empa 10mg		Alpha-GI: Empa 25mg		DPP-4 Inhibitor: Empa 10mg		DPP-4 Inhibitor: Empa 25mg		Glinide: Empa 10mg		Glinide: Empa 25mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Sulfonylurea: Empa 10mg		Sulfonylurea: Empa 25mg		Sulfonylurea: Metformin		Biguanide: Empa 10mg		Biguanide: Empa 25mg		Thiazolidinedione: Empa 10mg		Thiazolidinedione: Empa 25mg		Alpha-GI: Empa 10mg		Alpha-GI: Empa 25mg		DPP-4 Inhibitor: Empa 10mg		DPP-4 Inhibitor: Empa 25mg		Glinide: Empa 10mg		Glinide: Empa 25mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/136 (7.4%)		7/137 (5.1%)		3/63 (4.8%)		7/68 (10.3%)		2/65 (3.1%)		12/137 (8.8%)		12/136 (8.8%)		2/69 (2.9%)		5/70 (7.1%)		7/68 (10.3%)		5/71 (7%)		1/70 (1.4%)		4/70 (5.7%)
Blood and lymphatic system disorders
Anaemia	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		1/70 (1.4%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Cardiac disorders
Acute myocardial infarction	1/136 (0.7%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		1/68 (1.5%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Congestive cardiomyopathy	0/136 (0%)		0/137 (0%)		0/63 (0%)		1/68 (1.5%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Coronary artery stenosis	0/136 (0%)		0/137 (0%)		0/63 (0%)		1/68 (1.5%)		1/65 (1.5%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Myocardial infarction	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		1/68 (1.5%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Prinzmetal angina	0/136 (0%)		0/137 (0%)		0/63 (0%)		1/68 (1.5%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Angina pectoris	1/136 (0.7%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		1/137 (0.7%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Arteriosclerosis coronary artery	1/136 (0.7%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Atrial fibrillation	0/136 (0%)		1/137 (0.7%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Cardiac failure congestive	0/136 (0%)		1/137 (0.7%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Eye disorders
Cataract	0/136 (0%)		2/137 (1.5%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		1/136 (0.7%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		1/70 (1.4%)		0/70 (0%)
Glaucoma	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		1/70 (1.4%)
Retinal detachment	0/136 (0%)		1/137 (0.7%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Gastrointestinal disorders
Anal fissure	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		1/70 (1.4%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Gastrointestinal haemorrhage	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		1/70 (1.4%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Haemorrhoids	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		1/71 (1.4%)		0/70 (0%)		0/70 (0%)
Inguinal hernia	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		1/71 (1.4%)		0/70 (0%)		0/70 (0%)
Colitis ischaemic	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		1/136 (0.7%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Colonic polyp	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		1/137 (0.7%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Duodenitis	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		1/136 (0.7%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Leukoplakia oral	1/136 (0.7%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Megacolon	1/136 (0.7%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Melaena	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		1/136 (0.7%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
General disorders
Chest pain	0/136 (0%)		0/137 (0%)		0/63 (0%)		1/68 (1.5%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Hepatobiliary disorders
Drug-induced liver injury	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		1/137 (0.7%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Immune system disorders
Anaphylactic reaction	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		1/69 (1.4%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Infections and infestations
Urinary tract infection	0/136 (0%)		0/137 (0%)		0/63 (0%)		1/68 (1.5%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Cellulitis	0/136 (0%)		1/137 (0.7%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		1/137 (0.7%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		1/70 (1.4%)
Febrile infection	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		1/71 (1.4%)		0/70 (0%)		0/70 (0%)
Gangrene	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		1/70 (1.4%)
Osteomyelitis	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		1/70 (1.4%)
Pneumonia	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		1/137 (0.7%)		1/136 (0.7%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Pulmonary tuberculosis	0/136 (0%)		1/137 (0.7%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Pyelonephritis	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		1/136 (0.7%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Injury, poisoning and procedural complications
Femur fracture	0/136 (0%)		0/137 (0%)		0/63 (0%)		1/68 (1.5%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		1/68 (1.5%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Ankle fracture	0/136 (0%)		1/137 (0.7%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		1/136 (0.7%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Heat illness	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		1/136 (0.7%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Pelvic fracture	1/136 (0.7%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		1/136 (0.7%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Subdural haematoma	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		1/137 (0.7%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		1/68 (1.5%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Lumbar spinal stenosis	1/136 (0.7%)		0/137 (0%)		0/63 (0%)		1/68 (1.5%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Polyarthritis	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		1/69 (1.4%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Rotator cuff syndrome	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		1/137 (0.7%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Spinal column stenosis	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		1/137 (0.7%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer	0/136 (0%)		0/137 (0%)		1/63 (1.6%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		1/70 (1.4%)
Gastric cancer	0/136 (0%)		1/137 (0.7%)		1/63 (1.6%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		1/71 (1.4%)		0/70 (0%)		0/70 (0%)
Lung neoplasm malignant	0/136 (0%)		0/137 (0%)		1/63 (1.6%)		0/68 (0%)		0/65 (0%)		1/137 (0.7%)		1/136 (0.7%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Benign ovarian tumour	0/136 (0%)		0/137 (0%)		0/63 (0%)		1/68 (1.5%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Prostate cancer	1/136 (0.7%)		1/137 (0.7%)		0/63 (0%)		0/68 (0%)		1/65 (1.5%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		1/70 (1.4%)		0/68 (0%)		1/71 (1.4%)		0/70 (0%)		0/70 (0%)
Meningioma	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		1/71 (1.4%)		0/70 (0%)		0/70 (0%)
Oropharyngeal cancer stage unspecified	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		1/70 (1.4%)
Uterine cancer	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		1/70 (1.4%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Rectal cancer	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		1/137 (0.7%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Small cell lung cancer stage unspecified	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		1/136 (0.7%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Nervous system disorders
Lacunar infarction	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		1/68 (1.5%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Carotid artery stenosis	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		1/137 (0.7%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Cerebral arteriosclerosis	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		1/137 (0.7%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Cerebral infarction	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		1/137 (0.7%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Transient ischaemic attack	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		1/136 (0.7%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
VIIth nerve paralysis	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		1/136 (0.7%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Psychiatric disorders
Schizophrenia	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		1/70 (1.4%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Renal and urinary disorders
Bladder prolapse	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		1/68 (1.5%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Calculus ureteric	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		1/137 (0.7%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Diabetic nephropathy	1/136 (0.7%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Nephrolithiasis	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		1/136 (0.7%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Reproductive system and breast disorders
Benign prostatic hyperplasia	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		1/68 (1.5%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Respiratory, thoracic and mediastinal disorders
Hyperventilation	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		1/137 (0.7%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Sleep apnoea syndrome	1/136 (0.7%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Vascular disorders
Embolism arterial	0/136 (0%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		1/70 (1.4%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Artery dissection	1/136 (0.7%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Peripheral arterial occlusive disease	1/136 (0.7%)		0/137 (0%)		0/63 (0%)		0/68 (0%)		0/65 (0%)		0/137 (0%)		0/136 (0%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		0/71 (0%)		0/70 (0%)		0/70 (0%)
Other (Not Including Serious) Adverse Events
	Sulfonylurea: Empa 10mg		Sulfonylurea: Empa 25mg		Sulfonylurea: Metformin		Biguanide: Empa 10mg		Biguanide: Empa 25mg		Thiazolidinedione: Empa 10mg		Thiazolidinedione: Empa 25mg		Alpha-GI: Empa 10mg		Alpha-GI: Empa 25mg		DPP-4 Inhibitor: Empa 10mg		DPP-4 Inhibitor: Empa 25mg		Glinide: Empa 10mg		Glinide: Empa 25mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	73/136 (53.7%)		74/137 (54%)		44/63 (69.8%)		32/68 (47.1%)		35/65 (53.8%)		77/137 (56.2%)		74/136 (54.4%)		40/69 (58%)		34/70 (48.6%)		37/68 (54.4%)		36/71 (50.7%)		30/70 (42.9%)		38/70 (54.3%)
Gastrointestinal disorders
Constipation	5/136 (3.7%)		5/137 (3.6%)		2/63 (3.2%)		4/68 (5.9%)		3/65 (4.6%)		9/137 (6.6%)		1/136 (0.7%)		1/69 (1.4%)		8/70 (11.4%)		5/68 (7.4%)		7/71 (9.9%)		3/70 (4.3%)		0/70 (0%)
Diarrhoea	2/136 (1.5%)		2/137 (1.5%)		5/63 (7.9%)		6/68 (8.8%)		4/65 (6.2%)		5/137 (3.6%)		2/136 (1.5%)		2/69 (2.9%)		4/70 (5.7%)		0/68 (0%)		1/71 (1.4%)		1/70 (1.4%)		1/70 (1.4%)
Gastritis	3/136 (2.2%)		2/137 (1.5%)		2/63 (3.2%)		1/68 (1.5%)		1/65 (1.5%)		4/137 (2.9%)		2/136 (1.5%)		2/69 (2.9%)		4/70 (5.7%)		0/68 (0%)		0/71 (0%)		1/70 (1.4%)		2/70 (2.9%)
General disorders
Thirst	2/136 (1.5%)		0/137 (0%)		0/63 (0%)		4/68 (5.9%)		0/65 (0%)		0/137 (0%)		2/136 (1.5%)		0/69 (0%)		0/70 (0%)		1/68 (1.5%)		0/71 (0%)		2/70 (2.9%)		0/70 (0%)
Infections and infestations
Nasopharyngitis	41/136 (30.1%)		38/137 (27.7%)		26/63 (41.3%)		12/68 (17.6%)		23/65 (35.4%)		44/137 (32.1%)		37/136 (27.2%)		26/69 (37.7%)		21/70 (30%)		23/68 (33.8%)		15/71 (21.1%)		16/70 (22.9%)		17/70 (24.3%)
Influenza	1/136 (0.7%)		2/137 (1.5%)		5/63 (7.9%)		3/68 (4.4%)		2/65 (3.1%)		1/137 (0.7%)		3/136 (2.2%)		2/69 (2.9%)		2/70 (2.9%)		2/68 (2.9%)		0/71 (0%)		0/70 (0%)		3/70 (4.3%)
Pharyngitis	3/136 (2.2%)		7/137 (5.1%)		2/63 (3.2%)		1/68 (1.5%)		1/65 (1.5%)		6/137 (4.4%)		6/136 (4.4%)		0/69 (0%)		2/70 (2.9%)		2/68 (2.9%)		5/71 (7%)		2/70 (2.9%)		5/70 (7.1%)
Vulvovaginal candidiasis	0/136 (0%)		0/137 (0%)		0/63 (0%)		4/68 (5.9%)		1/65 (1.5%)		2/137 (1.5%)		1/136 (0.7%)		2/69 (2.9%)		3/70 (4.3%)		0/68 (0%)		1/71 (1.4%)		0/70 (0%)		0/70 (0%)
Gastroenteritis	1/136 (0.7%)		4/137 (2.9%)		2/63 (3.2%)		0/68 (0%)		2/65 (3.1%)		4/137 (2.9%)		1/136 (0.7%)		1/69 (1.4%)		4/70 (5.7%)		1/68 (1.5%)		1/71 (1.4%)		1/70 (1.4%)		2/70 (2.9%)
Bronchitis	7/136 (5.1%)		0/137 (0%)		0/63 (0%)		3/68 (4.4%)		3/65 (4.6%)		2/137 (1.5%)		5/136 (3.7%)		1/69 (1.4%)		0/70 (0%)		2/68 (2.9%)		3/71 (4.2%)		1/70 (1.4%)		3/70 (4.3%)
Injury, poisoning and procedural complications
Fall	4/136 (2.9%)		6/137 (4.4%)		5/63 (7.9%)		2/68 (2.9%)		1/65 (1.5%)		9/137 (6.6%)		8/136 (5.9%)		3/69 (4.3%)		2/70 (2.9%)		4/68 (5.9%)		4/71 (5.6%)		3/70 (4.3%)		2/70 (2.9%)
Contusion	2/136 (1.5%)		3/137 (2.2%)		4/63 (6.3%)		0/68 (0%)		1/65 (1.5%)		2/137 (1.5%)		5/136 (3.7%)		2/69 (2.9%)		4/70 (5.7%)		2/68 (2.9%)		4/71 (5.6%)		1/70 (1.4%)		1/70 (1.4%)
Metabolism and nutrition disorders
Hypoglycaemia	11/136 (8.1%)		12/137 (8.8%)		6/63 (9.5%)		2/68 (2.9%)		3/65 (4.6%)		4/137 (2.9%)		2/136 (1.5%)		0/69 (0%)		0/70 (0%)		0/68 (0%)		3/71 (4.2%)		0/70 (0%)		3/70 (4.3%)
Musculoskeletal and connective tissue disorders
Back pain	3/136 (2.2%)		7/137 (5.1%)		1/63 (1.6%)		0/68 (0%)		5/65 (7.7%)		8/137 (5.8%)		8/136 (5.9%)		2/69 (2.9%)		1/70 (1.4%)		1/68 (1.5%)		5/71 (7%)		4/70 (5.7%)		3/70 (4.3%)
Nervous system disorders
Dizziness	2/136 (1.5%)		2/137 (1.5%)		2/63 (3.2%)		4/68 (5.9%)		0/65 (0%)		4/137 (2.9%)		4/136 (2.9%)		3/69 (4.3%)		1/70 (1.4%)		3/68 (4.4%)		2/71 (2.8%)		6/70 (8.6%)		2/70 (2.9%)
Renal and urinary disorders
Pollakiuria	3/136 (2.2%)		6/137 (4.4%)		0/63 (0%)		2/68 (2.9%)		0/65 (0%)		11/137 (8%)		3/136 (2.2%)		2/69 (2.9%)		3/70 (4.3%)		4/68 (5.9%)		7/71 (9.9%)		3/70 (4.3%)		5/70 (7.1%)
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation	7/136 (5.1%)		6/137 (4.4%)		4/63 (6.3%)		0/68 (0%)		3/65 (4.6%)		3/137 (2.2%)		1/136 (0.7%)		1/69 (1.4%)		2/70 (2.9%)		0/68 (0%)		0/71 (0%)		1/70 (1.4%)		1/70 (1.4%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.