Diabetes Mellitus, Type 2
Conditions
Brief summary
The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.
Interventions
DRUGBI 10773
BI 10773 high dose once daily
DRUGMetformin
open label comparator
DRUGSitagliptin
open label comparator
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients completing one of double blind phase II trials 1245.9 or 1245.10 * informed consent
Exclusion criteria
* patients meeting withdrawal criteria of preceding trial * significant hepatic impairment * significant renal impairment with creatinine clearance \< 50 ml/min * contraindication to Metformin for all patients treated with Metformin * premenopausal women that are nursing or pregnant or not practicing acceptable methods of birth control * drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycaemic Events | 78 weeks plus 1 week of follow-up | Investigator defined Hypoglycaemic events. For documentation of hypoglycemic events, the following criteria were taken into consideration: * Asymptomatic hypoglycemia: the event was not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤70 mg/dL (≤3.9 mmol/L) * Documented symptomatic hypoglycemia with glucose of ≥54 mg/dL and ≤70 mg/dL (≥3.0 mmol/L and ≤3.9 mmol/L) * Documented symptomatic hypoglycemia with glucose of \<54 mg/dL (\<3.0 mmol/L): the event was accompanied by typical symptoms of hypoglycemia but in no need for external assistance * Severe hypoglycemic episode: the event required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions |
| Change From Baseline to Week 78 in Lipid Parameters | Weeks 1 and 78 | Change from baseline to week 78 in lipid parameters (Total cholesterol, High-density lipoprotein (HDL), Low-density lipoprotein (LDL) and Triglyceride) |
| Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | 78 weeks plus 1 week of follow-up | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements. New abnormal findings or worsening of baseline conditions were reported as treatment related Adverse Events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of a Relative Efficacy Response | Weeks 1, 6, 18, 30, 42, 54, 66 and 78 | Occurrence of a Relative Efficacy Response (HbA1c Lowered by at least \>=0.5% over time) |
| Change From Baseline in HbA1c Over Time | Weeks 1, 6, 18, 30, 42, 54, 66 and 78 | Baseline source: before first intake of active treatment (preceding trial or Open label extension) |
| Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Weeks 1, 6, 18, 30, 42, 54, 66 and 78 | Baseline source: before first intake of active treatment (preceding trial or Open label extension) |
| Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Weeks 1, 6, 18, 30, 42, 54, 66 and 78 | Occurence of a treat-to-target response, defined as HbA1c \< 7.0% over time |
| Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Weeks 1, 6, 18, 30, 42, 54, 66 and 78 | Occurrence of a Treat-to-target Response, defined as HbA1c \< 6.5% over time |
Countries
Austria, Croatia, Czechia, Estonia, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, Norway, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Taiwan, Ukraine, United States
Participant flow
Recruitment details
This was an open label extension trial of the blinded 12-week dose-finding studies NCT00789035 and NCT00749190.
Pre-assignment details
Patients from the preceding empagliflozin 10 and 25 mg groups continued to take the same doses. Patients on placebo and other empagliflozin doses were re-randomised to one of the empagliflozin treatments. Patients on metformin monotherapy or sitagliptin added-on to metformin in the preceding trials continued their open label treatments.
Participants by arm
| Arm | Count |
|---|---|
| Empagliflozin 10 mg Patients receive 10 mg Empagliflozin in tablets once daily. | 106 |
| Empagliflozin 25 mg Patients receive 25 mg Empagliflozin in tablets once daily. | 109 |
| Metformin Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial. | 56 |
| Empagliflozin 10 mg + Metformin Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study. | 166 |
| Empagliflozin 25 mg + Metformin Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study. | 166 |
| Sitaglipin + Metformin Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study. | 56 |
| Total | 659 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 1 | 1 | 4 | 10 | 2 |
| Overall Study | Lack of Efficacy | 1 | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 | 1 | 3 | 1 | 0 |
| Overall Study | Not compliant with the protocol | 0 | 0 | 0 | 0 | 2 | 0 |
| Overall Study | Other reason not defined above | 1 | 1 | 2 | 0 | 0 | 2 |
| Overall Study | Refused to continue medication | 7 | 2 | 1 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Empagliflozin 10 mg | Empagliflozin 25 mg | Metformin | Empagliflozin 10 mg + Metformin | Empagliflozin 25 mg + Metformin | Sitaglipin + Metformin | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 58.3 years STANDARD_DEVIATION 8.5 | 58.5 years STANDARD_DEVIATION 10 | 56.8 years STANDARD_DEVIATION 8.9 | 58.4 years STANDARD_DEVIATION 8.3 | 59.9 years STANDARD_DEVIATION 7.8 | 58.3 years STANDARD_DEVIATION 10.5 | 58.6 years STANDARD_DEVIATION 8.8 |
| Sex: Female, Male Female | 57 Participants | 52 Participants | 28 Participants | 83 Participants | 78 Participants | 27 Participants | 325 Participants |
| Sex: Female, Male Male | 49 Participants | 57 Participants | 28 Participants | 83 Participants | 88 Participants | 29 Participants | 334 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 34 / 106 | 46 / 109 | 27 / 56 | 74 / 166 | 79 / 166 | 26 / 56 |
| serious Total, serious adverse events | 10 / 106 | 7 / 109 | 3 / 56 | 10 / 166 | 13 / 166 | 9 / 56 |
Outcome results
Primary
Change From Baseline to Week 78 in Lipid Parameters
Change from baseline to week 78 in lipid parameters (Total cholesterol, High-density lipoprotein (HDL), Low-density lipoprotein (LDL) and Triglyceride)
Time frame: Weeks 1 and 78
Population: Treated set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Empagliflozin 10 mg | Change From Baseline to Week 78 in Lipid Parameters | Triglyceride | -0.5 mmol/L | Standard Deviation 2.3 |
| Empagliflozin 10 mg | Change From Baseline to Week 78 in Lipid Parameters | HDL | 0.08 mmol/L | Standard Deviation 0.11 |
| Empagliflozin 10 mg | Change From Baseline to Week 78 in Lipid Parameters | Total Cholesterol | -0.13 mmol/L | Standard Deviation 1.17 |
| Empagliflozin 10 mg | Change From Baseline to Week 78 in Lipid Parameters | LDL (N=102, 108, 52, 161, 159, 55) | -0.02 mmol/L | Standard Deviation 0.83 |
| Empagliflozin 25 mg | Change From Baseline to Week 78 in Lipid Parameters | LDL (N=102, 108, 52, 161, 159, 55) | 0.05 mmol/L | Standard Deviation 0.83 |
| Empagliflozin 25 mg | Change From Baseline to Week 78 in Lipid Parameters | Total Cholesterol | 0.09 mmol/L | Standard Deviation 0.88 |
| Empagliflozin 25 mg | Change From Baseline to Week 78 in Lipid Parameters | Triglyceride | -0.0 mmol/L | Standard Deviation 0.6 |
| Empagliflozin 25 mg | Change From Baseline to Week 78 in Lipid Parameters | HDL | 0.07 mmol/L | Standard Deviation 0.1 |
| Metformin | Change From Baseline to Week 78 in Lipid Parameters | Total Cholesterol | -0.24 mmol/L | Standard Deviation 0.77 |
| Metformin | Change From Baseline to Week 78 in Lipid Parameters | Triglyceride | -0.5 mmol/L | Standard Deviation 1.2 |
| Metformin | Change From Baseline to Week 78 in Lipid Parameters | HDL | 0.06 mmol/L | Standard Deviation 0.1 |
| Metformin | Change From Baseline to Week 78 in Lipid Parameters | LDL (N=102, 108, 52, 161, 159, 55) | -0.13 mmol/L | Standard Deviation 0.74 |
| Empagliflozin 10 mg + Metformin | Change From Baseline to Week 78 in Lipid Parameters | Triglyceride | 0.1 mmol/L | Standard Deviation 0.9 |
| Empagliflozin 10 mg + Metformin | Change From Baseline to Week 78 in Lipid Parameters | HDL | 0.06 mmol/L | Standard Deviation 0.09 |
| Empagliflozin 10 mg + Metformin | Change From Baseline to Week 78 in Lipid Parameters | LDL (N=102, 108, 52, 161, 159, 55) | 0.13 mmol/L | Standard Deviation 0.71 |
| Empagliflozin 10 mg + Metformin | Change From Baseline to Week 78 in Lipid Parameters | Total Cholesterol | 0.19 mmol/L | Standard Deviation 0.81 |
| Empagliflozin 25 mg + Metformin | Change From Baseline to Week 78 in Lipid Parameters | HDL | 0.07 mmol/L | Standard Deviation 0.1 |
| Empagliflozin 25 mg + Metformin | Change From Baseline to Week 78 in Lipid Parameters | Total Cholesterol | 0.13 mmol/L | Standard Deviation 0.75 |
| Empagliflozin 25 mg + Metformin | Change From Baseline to Week 78 in Lipid Parameters | LDL (N=102, 108, 52, 161, 159, 55) | 0.07 mmol/L | Standard Deviation 0.69 |
| Empagliflozin 25 mg + Metformin | Change From Baseline to Week 78 in Lipid Parameters | Triglyceride | -0.1 mmol/L | Standard Deviation 0.8 |
| Sitaglipin + Metformin | Change From Baseline to Week 78 in Lipid Parameters | HDL | 0.03 mmol/L | Standard Deviation 0.08 |
| Sitaglipin + Metformin | Change From Baseline to Week 78 in Lipid Parameters | Total Cholesterol | -0.05 mmol/L | Standard Deviation 0.91 |
| Sitaglipin + Metformin | Change From Baseline to Week 78 in Lipid Parameters | Triglyceride | -0.2 mmol/L | Standard Deviation 0.9 |
| Sitaglipin + Metformin | Change From Baseline to Week 78 in Lipid Parameters | LDL (N=102, 108, 52, 161, 159, 55) | 0.00 mmol/L | Standard Deviation 0.79 |
Primary
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements. New abnormal findings or worsening of baseline conditions were reported as treatment related Adverse Events.
Time frame: 78 weeks plus 1 week of follow-up
Population: Treated set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Empagliflozin 10 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Weight decreased | 0.0 percentage of participants |
| Empagliflozin 10 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Gamma-glutamyltransferase increased | 0.9 percentage of participants |
| Empagliflozin 10 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Aspartate aminotransferase increased | 1.9 percentage of participants |
| Empagliflozin 10 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Tachycardia | 0.9 percentage of participants |
| Empagliflozin 10 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Blood creatinine increased | 0.9 percentage of participants |
| Empagliflozin 10 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Creatinine renal clearance decreased | 0.0 percentage of participants |
| Empagliflozin 10 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Granulocyte count decreased | 0.9 percentage of participants |
| Empagliflozin 10 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Hepatic enzyme increased | 0.0 percentage of participants |
| Empagliflozin 10 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Sick sinus syndrome | 0.9 percentage of participants |
| Empagliflozin 10 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Blood creatine phosphokinase increased | 0.9 percentage of participants |
| Empagliflozin 10 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Alanine aminotransferase increased | 0.9 percentage of participants |
| Empagliflozin 10 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Blood alkaline phosphatase increased | 0.9 percentage of participants |
| Empagliflozin 25 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Blood alkaline phosphatase increased | 0.0 percentage of participants |
| Empagliflozin 25 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Alanine aminotransferase increased | 0.9 percentage of participants |
| Empagliflozin 25 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Blood creatine phosphokinase increased | 0.0 percentage of participants |
| Empagliflozin 25 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Granulocyte count decreased | 0.0 percentage of participants |
| Empagliflozin 25 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Aspartate aminotransferase increased | 0.0 percentage of participants |
| Empagliflozin 25 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Blood creatinine increased | 0.9 percentage of participants |
| Empagliflozin 25 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Creatinine renal clearance decreased | 0.0 percentage of participants |
| Empagliflozin 25 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Hepatic enzyme increased | 0.9 percentage of participants |
| Empagliflozin 25 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Weight decreased | 0.9 percentage of participants |
| Empagliflozin 25 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Gamma-glutamyltransferase increased | 0.0 percentage of participants |
| Empagliflozin 25 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Sick sinus syndrome | 0.0 percentage of participants |
| Empagliflozin 25 mg | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Tachycardia | 1.8 percentage of participants |
| Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Blood creatine phosphokinase increased | 0.0 percentage of participants |
| Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Weight decreased | 0.0 percentage of participants |
| Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Gamma-glutamyltransferase increased | 1.8 percentage of participants |
| Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Tachycardia | 0.0 percentage of participants |
| Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Alanine aminotransferase increased | 3.6 percentage of participants |
| Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Sick sinus syndrome | 0.0 percentage of participants |
| Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Blood alkaline phosphatase increased | 0.0 percentage of participants |
| Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Creatinine renal clearance decreased | 0.0 percentage of participants |
| Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Blood creatinine increased | 0.0 percentage of participants |
| Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Hepatic enzyme increased | 0.0 percentage of participants |
| Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Aspartate aminotransferase increased | 1.8 percentage of participants |
| Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Granulocyte count decreased | 0.0 percentage of participants |
| Empagliflozin 10 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Tachycardia | 0.6 percentage of participants |
| Empagliflozin 10 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Blood alkaline phosphatase increased | 0.0 percentage of participants |
| Empagliflozin 10 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Blood creatinine increased | 0.0 percentage of participants |
| Empagliflozin 10 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Creatinine renal clearance decreased | 0.6 percentage of participants |
| Empagliflozin 10 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Weight decreased | 0.0 percentage of participants |
| Empagliflozin 10 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Sick sinus syndrome | 0.0 percentage of participants |
| Empagliflozin 10 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Alanine aminotransferase increased | 0.6 percentage of participants |
| Empagliflozin 10 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Aspartate aminotransferase increased | 0.0 percentage of participants |
| Empagliflozin 10 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Gamma-glutamyltransferase increased | 0.0 percentage of participants |
| Empagliflozin 10 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Blood creatine phosphokinase increased | 0.0 percentage of participants |
| Empagliflozin 10 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Granulocyte count decreased | 0.0 percentage of participants |
| Empagliflozin 10 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Hepatic enzyme increased | 0.6 percentage of participants |
| Empagliflozin 25 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Gamma-glutamyltransferase increased | 1.2 percentage of participants |
| Empagliflozin 25 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Tachycardia | 0.6 percentage of participants |
| Empagliflozin 25 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Blood creatine phosphokinase increased | 0.0 percentage of participants |
| Empagliflozin 25 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Sick sinus syndrome | 0.0 percentage of participants |
| Empagliflozin 25 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Blood alkaline phosphatase increased | 0.0 percentage of participants |
| Empagliflozin 25 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Granulocyte count decreased | 0.0 percentage of participants |
| Empagliflozin 25 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Weight decreased | 0.6 percentage of participants |
| Empagliflozin 25 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Creatinine renal clearance decreased | 0.0 percentage of participants |
| Empagliflozin 25 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Hepatic enzyme increased | 0.0 percentage of participants |
| Empagliflozin 25 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Blood creatinine increased | 0.6 percentage of participants |
| Empagliflozin 25 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Aspartate aminotransferase increased | 0.6 percentage of participants |
| Empagliflozin 25 mg + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Alanine aminotransferase increased | 0.6 percentage of participants |
| Sitaglipin + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Blood creatinine increased | 0.0 percentage of participants |
| Sitaglipin + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Gamma-glutamyltransferase increased | 0.0 percentage of participants |
| Sitaglipin + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Tachycardia | 0.0 percentage of participants |
| Sitaglipin + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Creatinine renal clearance decreased | 0.0 percentage of participants |
| Sitaglipin + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Sick sinus syndrome | 0.0 percentage of participants |
| Sitaglipin + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Blood alkaline phosphatase increased | 0.0 percentage of participants |
| Sitaglipin + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Aspartate aminotransferase increased | 0.0 percentage of participants |
| Sitaglipin + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Blood creatine phosphokinase increased | 0.0 percentage of participants |
| Sitaglipin + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Alanine aminotransferase increased | 1.8 percentage of participants |
| Sitaglipin + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Weight decreased | 0.0 percentage of participants |
| Sitaglipin + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Hepatic enzyme increased | 0.0 percentage of participants |
| Sitaglipin + Metformin | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements | Granulocyte count decreased | 0.0 percentage of participants |
Primary
Hypoglycaemic Events
Investigator defined Hypoglycaemic events. For documentation of hypoglycemic events, the following criteria were taken into consideration: * Asymptomatic hypoglycemia: the event was not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤70 mg/dL (≤3.9 mmol/L) * Documented symptomatic hypoglycemia with glucose of ≥54 mg/dL and ≤70 mg/dL (≥3.0 mmol/L and ≤3.9 mmol/L) * Documented symptomatic hypoglycemia with glucose of \<54 mg/dL (\<3.0 mmol/L): the event was accompanied by typical symptoms of hypoglycemia but in no need for external assistance * Severe hypoglycemic episode: the event required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions
Time frame: 78 weeks plus 1 week of follow-up
Population: Treated set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Empagliflozin 10 mg | Hypoglycaemic Events | 0.9 percentage of participants |
| Empagliflozin 25 mg | Hypoglycaemic Events | 1.8 percentage of participants |
| Metformin | Hypoglycaemic Events | 7.1 percentage of participants |
| Empagliflozin 10 mg + Metformin | Hypoglycaemic Events | 2.4 percentage of participants |
| Empagliflozin 25 mg + Metformin | Hypoglycaemic Events | 3.6 percentage of participants |
| Sitaglipin + Metformin | Hypoglycaemic Events | 5.4 percentage of participants |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) Over Time
Baseline source: before first intake of active treatment (preceding trial or Open label extension)
Time frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78
Population: Treated set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Empagliflozin 10 mg | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 6 (N=102, 108, 55, 156, 160, 53) | -30.6 mg/dL | Standard Deviation 42.5 |
| Empagliflozin 10 mg | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 54 (N=80, 88, 44, 124, 134, 39) | -32.1 mg/dL | Standard Deviation 37.2 |
| Empagliflozin 10 mg | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 18 (N=94, 103, 51, 144, 153, 45) | -35.5 mg/dL | Standard Deviation 37.9 |
| Empagliflozin 10 mg | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 78 (N=72, 84, 43, 112, 121, 36) | -27.9 mg/dL | Standard Deviation 33.1 |
| Empagliflozin 10 mg | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 30 (N=92, 101, 51, 133, 147, 43) | -32.3 mg/dL | Standard Deviation 41.4 |
| Empagliflozin 10 mg | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 42 (N=85, 93, 46, 126, 140, 42) | -35.8 mg/dL | Standard Deviation 39.1 |
| Empagliflozin 10 mg | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 66 (N=80, 86, 43, 116, 125, 38) | -28.0 mg/dL | Standard Deviation 41.4 |
| Empagliflozin 25 mg | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 54 (N=80, 88, 44, 124, 134, 39) | -31.0 mg/dL | Standard Deviation 37.8 |
| Empagliflozin 25 mg | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 42 (N=85, 93, 46, 126, 140, 42) | -31.3 mg/dL | Standard Deviation 41.4 |
| Empagliflozin 25 mg | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 78 (N=72, 84, 43, 112, 121, 36) | -25.4 mg/dL | Standard Deviation 40.9 |
| Empagliflozin 25 mg | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 6 (N=102, 108, 55, 156, 160, 53) | -35.8 mg/dL | Standard Deviation 39.6 |
| Empagliflozin 25 mg | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 66 (N=80, 86, 43, 116, 125, 38) | -28.6 mg/dL | Standard Deviation 42.6 |
| Empagliflozin 25 mg | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 18 (N=94, 103, 51, 144, 153, 45) | -33.7 mg/dL | Standard Deviation 42 |
| Empagliflozin 25 mg | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 30 (N=92, 101, 51, 133, 147, 43) | -35.0 mg/dL | Standard Deviation 39.6 |
| Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 30 (N=92, 101, 51, 133, 147, 43) | -28.5 mg/dL | Standard Deviation 28.9 |
| Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 18 (N=94, 103, 51, 144, 153, 45) | -30.4 mg/dL | Standard Deviation 40.3 |
| Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 66 (N=80, 86, 43, 116, 125, 38) | -26.4 mg/dL | Standard Deviation 35.7 |
| Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 42 (N=85, 93, 46, 126, 140, 42) | -31.0 mg/dL | Standard Deviation 35.6 |
| Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 78 (N=72, 84, 43, 112, 121, 36) | -22.9 mg/dL | Standard Deviation 39.7 |
| Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 54 (N=80, 88, 44, 124, 134, 39) | -31.8 mg/dL | Standard Deviation 35.9 |
| Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 6 (N=102, 108, 55, 156, 160, 53) | -29.9 mg/dL | Standard Deviation 40 |
| Empagliflozin 10 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 66 (N=80, 86, 43, 116, 125, 38) | -21.7 mg/dL | Standard Deviation 36.2 |
| Empagliflozin 10 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 78 (N=72, 84, 43, 112, 121, 36) | -24.7 mg/dL | Standard Deviation 41.5 |
| Empagliflozin 10 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 6 (N=102, 108, 55, 156, 160, 53) | -25.7 mg/dL | Standard Deviation 35.2 |
| Empagliflozin 10 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 18 (N=94, 103, 51, 144, 153, 45) | -30.6 mg/dL | Standard Deviation 31.6 |
| Empagliflozin 10 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 30 (N=92, 101, 51, 133, 147, 43) | -29.9 mg/dL | Standard Deviation 34.9 |
| Empagliflozin 10 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 42 (N=85, 93, 46, 126, 140, 42) | -30.8 mg/dL | Standard Deviation 36.4 |
| Empagliflozin 10 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 54 (N=80, 88, 44, 124, 134, 39) | -28.2 mg/dL | Standard Deviation 33.7 |
| Empagliflozin 25 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 42 (N=85, 93, 46, 126, 140, 42) | -36.8 mg/dL | Standard Deviation 34.1 |
| Empagliflozin 25 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 30 (N=92, 101, 51, 133, 147, 43) | -37.9 mg/dL | Standard Deviation 38.6 |
| Empagliflozin 25 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 54 (N=80, 88, 44, 124, 134, 39) | -36.8 mg/dL | Standard Deviation 32.5 |
| Empagliflozin 25 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 6 (N=102, 108, 55, 156, 160, 53) | -36.7 mg/dL | Standard Deviation 36.3 |
| Empagliflozin 25 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 78 (N=72, 84, 43, 112, 121, 36) | -31.9 mg/dL | Standard Deviation 36.5 |
| Empagliflozin 25 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 18 (N=94, 103, 51, 144, 153, 45) | -37.6 mg/dL | Standard Deviation 35.8 |
| Empagliflozin 25 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 66 (N=80, 86, 43, 116, 125, 38) | -29.6 mg/dL | Standard Deviation 36.4 |
| Sitaglipin + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 54 (N=80, 88, 44, 124, 134, 39) | -29.4 mg/dL | Standard Deviation 35.4 |
| Sitaglipin + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 30 (N=92, 101, 51, 133, 147, 43) | -25.6 mg/dL | Standard Deviation 38.6 |
| Sitaglipin + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 18 (N=94, 103, 51, 144, 153, 45) | -16.7 mg/dL | Standard Deviation 44 |
| Sitaglipin + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 6 (N=102, 108, 55, 156, 160, 53) | -32.6 mg/dL | Standard Deviation 42.4 |
| Sitaglipin + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 78 (N=72, 84, 43, 112, 121, 36) | -25.7 mg/dL | Standard Deviation 48.9 |
| Sitaglipin + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 42 (N=85, 93, 46, 126, 140, 42) | -18.5 mg/dL | Standard Deviation 43.1 |
| Sitaglipin + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) Over Time | Week 66 (N=80, 86, 43, 116, 125, 38) | -32.5 mg/dL | Standard Deviation 46.9 |
Secondary
Change From Baseline in HbA1c Over Time
Baseline source: before first intake of active treatment (preceding trial or Open label extension)
Time frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78
Population: Treated set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Empagliflozin 10 mg | Change From Baseline in HbA1c Over Time | Week 30 (N=93, 99, 50, 140, 151, 45) | -0.47 percentage of HbA1c | Standard Deviation 0.85 |
| Empagliflozin 10 mg | Change From Baseline in HbA1c Over Time | Week 6 (N=104, 108, 55, 162, 163, 54) | -0.40 percentage of HbA1c | Standard Deviation 0.77 |
| Empagliflozin 10 mg | Change From Baseline in HbA1c Over Time | Week 54 (N=78, 85, 44, 128, 136, 41) | -0.66 percentage of HbA1c | Standard Deviation 0.83 |
| Empagliflozin 10 mg | Change From Baseline in HbA1c Over Time | Week 42 (N=85, 93, 46, 132, 140, 44) | -0.59 percentage of HbA1c | Standard Deviation 0.87 |
| Empagliflozin 10 mg | Change From Baseline in HbA1c Over Time | Week 78 (N=72, 84, 42, 115, 121, 38) | -0.50 percentage of HbA1c | Standard Deviation 0.77 |
| Empagliflozin 10 mg | Change From Baseline in HbA1c Over Time | Week 66 (N=80, 87, 43, 120, 127, 39) | -0.55 percentage of HbA1c | Standard Deviation 0.8 |
| Empagliflozin 10 mg | Change From Baseline in HbA1c Over Time | Week 18 (N=93, 105, 53, 149, 157, 48) | -0.58 percentage of HbA1c | Standard Deviation 0.75 |
| Empagliflozin 25 mg | Change From Baseline in HbA1c Over Time | Week 18 (N=93, 105, 53, 149, 157, 48) | -0.72 percentage of HbA1c | Standard Deviation 0.88 |
| Empagliflozin 25 mg | Change From Baseline in HbA1c Over Time | Week 78 (N=72, 84, 42, 115, 121, 38) | -0.55 percentage of HbA1c | Standard Deviation 0.9 |
| Empagliflozin 25 mg | Change From Baseline in HbA1c Over Time | Week 54 (N=78, 85, 44, 128, 136, 41) | -0.71 percentage of HbA1c | Standard Deviation 0.87 |
| Empagliflozin 25 mg | Change From Baseline in HbA1c Over Time | Week 30 (N=93, 99, 50, 140, 151, 45) | -0.61 percentage of HbA1c | Standard Deviation 0.9 |
| Empagliflozin 25 mg | Change From Baseline in HbA1c Over Time | Week 66 (N=80, 87, 43, 120, 127, 39) | -0.71 percentage of HbA1c | Standard Deviation 1.01 |
| Empagliflozin 25 mg | Change From Baseline in HbA1c Over Time | Week 6 (N=104, 108, 55, 162, 163, 54) | -0.57 percentage of HbA1c | Standard Deviation 0.81 |
| Empagliflozin 25 mg | Change From Baseline in HbA1c Over Time | Week 42 (N=85, 93, 46, 132, 140, 44) | -0.74 percentage of HbA1c | Standard Deviation 0.98 |
| Metformin | Change From Baseline in HbA1c Over Time | Week 30 (N=93, 99, 50, 140, 151, 45) | -0.95 percentage of HbA1c | Standard Deviation 0.82 |
| Metformin | Change From Baseline in HbA1c Over Time | Week 42 (N=85, 93, 46, 132, 140, 44) | -1.10 percentage of HbA1c | Standard Deviation 0.8 |
| Metformin | Change From Baseline in HbA1c Over Time | Week 18 (N=93, 105, 53, 149, 157, 48) | -0.92 percentage of HbA1c | Standard Deviation 0.91 |
| Metformin | Change From Baseline in HbA1c Over Time | Week 6 (N=104, 108, 55, 162, 163, 54) | -1.03 percentage of HbA1c | Standard Deviation 0.76 |
| Metformin | Change From Baseline in HbA1c Over Time | Week 78 (N=72, 84, 42, 115, 121, 38) | -0.80 percentage of HbA1c | Standard Deviation 0.88 |
| Metformin | Change From Baseline in HbA1c Over Time | Week 54 (N=78, 85, 44, 128, 136, 41) | -1.13 percentage of HbA1c | Standard Deviation 0.89 |
| Metformin | Change From Baseline in HbA1c Over Time | Week 66 (N=80, 87, 43, 120, 127, 39) | -1.04 percentage of HbA1c | Standard Deviation 0.79 |
| Empagliflozin 10 mg + Metformin | Change From Baseline in HbA1c Over Time | Week 54 (N=78, 85, 44, 128, 136, 41) | -0.62 percentage of HbA1c | Standard Deviation 0.76 |
| Empagliflozin 10 mg + Metformin | Change From Baseline in HbA1c Over Time | Week 66 (N=80, 87, 43, 120, 127, 39) | -0.59 percentage of HbA1c | Standard Deviation 0.79 |
| Empagliflozin 10 mg + Metformin | Change From Baseline in HbA1c Over Time | Week 6 (N=104, 108, 55, 162, 163, 54) | -0.36 percentage of HbA1c | Standard Deviation 0.67 |
| Empagliflozin 10 mg + Metformin | Change From Baseline in HbA1c Over Time | Week 18 (N=93, 105, 53, 149, 157, 48) | -0.51 percentage of HbA1c | Standard Deviation 0.68 |
| Empagliflozin 10 mg + Metformin | Change From Baseline in HbA1c Over Time | Week 30 (N=93, 99, 50, 140, 151, 45) | -0.58 percentage of HbA1c | Standard Deviation 0.69 |
| Empagliflozin 10 mg + Metformin | Change From Baseline in HbA1c Over Time | Week 42 (N=85, 93, 46, 132, 140, 44) | -0.65 percentage of HbA1c | Standard Deviation 0.72 |
| Empagliflozin 10 mg + Metformin | Change From Baseline in HbA1c Over Time | Week 78 (N=72, 84, 42, 115, 121, 38) | -0.56 percentage of HbA1c | Standard Deviation 0.8 |
| Empagliflozin 25 mg + Metformin | Change From Baseline in HbA1c Over Time | Week 54 (N=78, 85, 44, 128, 136, 41) | -0.75 percentage of HbA1c | Standard Deviation 0.73 |
| Empagliflozin 25 mg + Metformin | Change From Baseline in HbA1c Over Time | Week 66 (N=80, 87, 43, 120, 127, 39) | -0.73 percentage of HbA1c | Standard Deviation 0.77 |
| Empagliflozin 25 mg + Metformin | Change From Baseline in HbA1c Over Time | Week 18 (N=93, 105, 53, 149, 157, 48) | -0.70 percentage of HbA1c | Standard Deviation 0.68 |
| Empagliflozin 25 mg + Metformin | Change From Baseline in HbA1c Over Time | Week 30 (N=93, 99, 50, 140, 151, 45) | -0.76 percentage of HbA1c | Standard Deviation 0.7 |
| Empagliflozin 25 mg + Metformin | Change From Baseline in HbA1c Over Time | Week 6 (N=104, 108, 55, 162, 163, 54) | -0.55 percentage of HbA1c | Standard Deviation 0.6 |
| Empagliflozin 25 mg + Metformin | Change From Baseline in HbA1c Over Time | Week 78 (N=72, 84, 42, 115, 121, 38) | -0.71 percentage of HbA1c | Standard Deviation 0.81 |
| Empagliflozin 25 mg + Metformin | Change From Baseline in HbA1c Over Time | Week 42 (N=85, 93, 46, 132, 140, 44) | -0.79 percentage of HbA1c | Standard Deviation 0.76 |
| Sitaglipin + Metformin | Change From Baseline in HbA1c Over Time | Week 42 (N=85, 93, 46, 132, 140, 44) | -0.51 percentage of HbA1c | Standard Deviation 1.03 |
| Sitaglipin + Metformin | Change From Baseline in HbA1c Over Time | Week 18 (N=93, 105, 53, 149, 157, 48) | -0.79 percentage of HbA1c | Standard Deviation 0.84 |
| Sitaglipin + Metformin | Change From Baseline in HbA1c Over Time | Week 6 (N=104, 108, 55, 162, 163, 54) | -0.75 percentage of HbA1c | Standard Deviation 0.8 |
| Sitaglipin + Metformin | Change From Baseline in HbA1c Over Time | Week 54 (N=78, 85, 44, 128, 136, 41) | -0.79 percentage of HbA1c | Standard Deviation 0.79 |
| Sitaglipin + Metformin | Change From Baseline in HbA1c Over Time | Week 66 (N=80, 87, 43, 120, 127, 39) | -0.78 percentage of HbA1c | Standard Deviation 0.9 |
| Sitaglipin + Metformin | Change From Baseline in HbA1c Over Time | Week 30 (N=93, 99, 50, 140, 151, 45) | -0.68 percentage of HbA1c | Standard Deviation 0.82 |
| Sitaglipin + Metformin | Change From Baseline in HbA1c Over Time | Week 78 (N=72, 84, 42, 115, 121, 38) | -0.66 percentage of HbA1c | Standard Deviation 0.99 |
Secondary
Occurence of a Treat-to-target Response (HbA1c < 7.0%)
Occurence of a treat-to-target response, defined as HbA1c \< 7.0% over time
Time frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78
Population: Treated set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Empagliflozin 10 mg | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 78 (N=72, 84, 42, 115, 121, 38) | 31.9 percentage of participants |
| Empagliflozin 10 mg | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 6 (N=104, 108, 55, 162, 163, 54) | 26.9 percentage of participants |
| Empagliflozin 10 mg | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 54 (N=78, 85, 44, 128, 136, 41) | 43.6 percentage of participants |
| Empagliflozin 10 mg | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 18 (N=93, 105, 53, 149, 157, 48) | 33.3 percentage of participants |
| Empagliflozin 10 mg | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 30 (N=93, 99, 50, 140, 151, 45) | 34.4 percentage of participants |
| Empagliflozin 10 mg | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 66 (N=80, 87, 43, 120, 127, 39) | 31.3 percentage of participants |
| Empagliflozin 10 mg | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 42 (N=85, 93, 46, 132, 140, 44) | 41.2 percentage of participants |
| Empagliflozin 25 mg | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 66 (N=80, 87, 43, 120, 127, 39) | 39.1 percentage of participants |
| Empagliflozin 25 mg | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 42 (N=85, 93, 46, 132, 140, 44) | 40.9 percentage of participants |
| Empagliflozin 25 mg | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 78 (N=72, 84, 42, 115, 121, 38) | 32.1 percentage of participants |
| Empagliflozin 25 mg | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 6 (N=104, 108, 55, 162, 163, 54) | 25.0 percentage of participants |
| Empagliflozin 25 mg | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 18 (N=93, 105, 53, 149, 157, 48) | 33.3 percentage of participants |
| Empagliflozin 25 mg | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 54 (N=78, 85, 44, 128, 136, 41) | 32.9 percentage of participants |
| Empagliflozin 25 mg | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 30 (N=93, 99, 50, 140, 151, 45) | 29.3 percentage of participants |
| Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 42 (N=85, 93, 46, 132, 140, 44) | 52.2 percentage of participants |
| Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 54 (N=78, 85, 44, 128, 136, 41) | 56.8 percentage of participants |
| Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 30 (N=93, 99, 50, 140, 151, 45) | 42.0 percentage of participants |
| Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 66 (N=80, 87, 43, 120, 127, 39) | 44.2 percentage of participants |
| Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 6 (N=104, 108, 55, 162, 163, 54) | 45.5 percentage of participants |
| Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 78 (N=72, 84, 42, 115, 121, 38) | 31.0 percentage of participants |
| Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 18 (N=93, 105, 53, 149, 157, 48) | 45.3 percentage of participants |
| Empagliflozin 10 mg + Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 66 (N=80, 87, 43, 120, 127, 39) | 35.8 percentage of participants |
| Empagliflozin 10 mg + Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 6 (N=104, 108, 55, 162, 163, 54) | 24.1 percentage of participants |
| Empagliflozin 10 mg + Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 18 (N=93, 105, 53, 149, 157, 48) | 31.5 percentage of participants |
| Empagliflozin 10 mg + Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 30 (N=93, 99, 50, 140, 151, 45) | 28.6 percentage of participants |
| Empagliflozin 10 mg + Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 42 (N=85, 93, 46, 132, 140, 44) | 39.4 percentage of participants |
| Empagliflozin 10 mg + Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 54 (N=78, 85, 44, 128, 136, 41) | 35.9 percentage of participants |
| Empagliflozin 10 mg + Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 78 (N=72, 84, 42, 115, 121, 38) | 27.0 percentage of participants |
| Empagliflozin 25 mg + Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 42 (N=85, 93, 46, 132, 140, 44) | 47.1 percentage of participants |
| Empagliflozin 25 mg + Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 30 (N=93, 99, 50, 140, 151, 45) | 45.7 percentage of participants |
| Empagliflozin 25 mg + Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 18 (N=93, 105, 53, 149, 157, 48) | 37.6 percentage of participants |
| Empagliflozin 25 mg + Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 78 (N=72, 84, 42, 115, 121, 38) | 44.6 percentage of participants |
| Empagliflozin 25 mg + Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 54 (N=78, 85, 44, 128, 136, 41) | 47.8 percentage of participants |
| Empagliflozin 25 mg + Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 6 (N=104, 108, 55, 162, 163, 54) | 25.2 percentage of participants |
| Empagliflozin 25 mg + Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 66 (N=80, 87, 43, 120, 127, 39) | 48.0 percentage of participants |
| Sitaglipin + Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 78 (N=72, 84, 42, 115, 121, 38) | 36.8 percentage of participants |
| Sitaglipin + Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 66 (N=80, 87, 43, 120, 127, 39) | 38.5 percentage of participants |
| Sitaglipin + Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 18 (N=93, 105, 53, 149, 157, 48) | 35.4 percentage of participants |
| Sitaglipin + Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 42 (N=85, 93, 46, 132, 140, 44) | 25.0 percentage of participants |
| Sitaglipin + Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 6 (N=104, 108, 55, 162, 163, 54) | 35.2 percentage of participants |
| Sitaglipin + Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 30 (N=93, 99, 50, 140, 151, 45) | 28.9 percentage of participants |
| Sitaglipin + Metformin | Occurence of a Treat-to-target Response (HbA1c < 7.0%) | Week 54 (N=78, 85, 44, 128, 136, 41) | 29.3 percentage of participants |
Secondary
Occurrence of a Relative Efficacy Response
Occurrence of a Relative Efficacy Response (HbA1c Lowered by at least \>=0.5% over time)
Time frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78
Population: Treated set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Empagliflozin 10 mg | Occurrence of a Relative Efficacy Response | Week 30 (N=93, 99, 50, 140, 151, 45) | 50.5 percentage of participants |
| Empagliflozin 10 mg | Occurrence of a Relative Efficacy Response | Week 18 (N=93, 105, 53, 149, 157, 48) | 51.6 percentage of participants |
| Empagliflozin 10 mg | Occurrence of a Relative Efficacy Response | Week 66 (N=80, 87, 43, 120, 127, 39) | 53.8 percentage of participants |
| Empagliflozin 10 mg | Occurrence of a Relative Efficacy Response | Week 6 (N=104, 108, 55, 162, 163, 54) | 42.3 percentage of participants |
| Empagliflozin 10 mg | Occurrence of a Relative Efficacy Response | Week 78 (N=72, 84, 42, 115, 121, 38) | 50.0 percentage of participants |
| Empagliflozin 10 mg | Occurrence of a Relative Efficacy Response | Week 54 (N=78, 85, 44, 128, 136, 41) | 62.8 percentage of participants |
| Empagliflozin 10 mg | Occurrence of a Relative Efficacy Response | Week 42 (N=85, 93, 46, 132, 140, 44) | 58.8 percentage of participants |
| Empagliflozin 25 mg | Occurrence of a Relative Efficacy Response | Week 66 (N=80, 87, 43, 120, 127, 39) | 56.3 percentage of participants |
| Empagliflozin 25 mg | Occurrence of a Relative Efficacy Response | Week 6 (N=104, 108, 55, 162, 163, 54) | 50.9 percentage of participants |
| Empagliflozin 25 mg | Occurrence of a Relative Efficacy Response | Week 18 (N=93, 105, 53, 149, 157, 48) | 61.9 percentage of participants |
| Empagliflozin 25 mg | Occurrence of a Relative Efficacy Response | Week 30 (N=93, 99, 50, 140, 151, 45) | 55.6 percentage of participants |
| Empagliflozin 25 mg | Occurrence of a Relative Efficacy Response | Week 42 (N=85, 93, 46, 132, 140, 44) | 60.2 percentage of participants |
| Empagliflozin 25 mg | Occurrence of a Relative Efficacy Response | Week 54 (N=78, 85, 44, 128, 136, 41) | 58.8 percentage of participants |
| Empagliflozin 25 mg | Occurrence of a Relative Efficacy Response | Week 78 (N=72, 84, 42, 115, 121, 38) | 50.0 percentage of participants |
| Metformin | Occurrence of a Relative Efficacy Response | Week 66 (N=80, 87, 43, 120, 127, 39) | 76.7 percentage of participants |
| Metformin | Occurrence of a Relative Efficacy Response | Week 78 (N=72, 84, 42, 115, 121, 38) | 66.7 percentage of participants |
| Metformin | Occurrence of a Relative Efficacy Response | Week 42 (N=85, 93, 46, 132, 140, 44) | 82.6 percentage of participants |
| Metformin | Occurrence of a Relative Efficacy Response | Week 54 (N=78, 85, 44, 128, 136, 41) | 81.8 percentage of participants |
| Metformin | Occurrence of a Relative Efficacy Response | Week 30 (N=93, 99, 50, 140, 151, 45) | 78.0 percentage of participants |
| Metformin | Occurrence of a Relative Efficacy Response | Week 18 (N=93, 105, 53, 149, 157, 48) | 77.4 percentage of participants |
| Metformin | Occurrence of a Relative Efficacy Response | Week 6 (N=104, 108, 55, 162, 163, 54) | 80.0 percentage of participants |
| Empagliflozin 10 mg + Metformin | Occurrence of a Relative Efficacy Response | Week 6 (N=104, 108, 55, 162, 163, 54) | 41.4 percentage of participants |
| Empagliflozin 10 mg + Metformin | Occurrence of a Relative Efficacy Response | Week 66 (N=80, 87, 43, 120, 127, 39) | 55.0 percentage of participants |
| Empagliflozin 10 mg + Metformin | Occurrence of a Relative Efficacy Response | Week 54 (N=78, 85, 44, 128, 136, 41) | 59.4 percentage of participants |
| Empagliflozin 10 mg + Metformin | Occurrence of a Relative Efficacy Response | Week 18 (N=93, 105, 53, 149, 157, 48) | 53.7 percentage of participants |
| Empagliflozin 10 mg + Metformin | Occurrence of a Relative Efficacy Response | Week 30 (N=93, 99, 50, 140, 151, 45) | 55.0 percentage of participants |
| Empagliflozin 10 mg + Metformin | Occurrence of a Relative Efficacy Response | Week 78 (N=72, 84, 42, 115, 121, 38) | 56.5 percentage of participants |
| Empagliflozin 10 mg + Metformin | Occurrence of a Relative Efficacy Response | Week 42 (N=85, 93, 46, 132, 140, 44) | 62.1 percentage of participants |
| Empagliflozin 25 mg + Metformin | Occurrence of a Relative Efficacy Response | Week 18 (N=93, 105, 53, 149, 157, 48) | 61.8 percentage of participants |
| Empagliflozin 25 mg + Metformin | Occurrence of a Relative Efficacy Response | Week 6 (N=104, 108, 55, 162, 163, 54) | 56.4 percentage of participants |
| Empagliflozin 25 mg + Metformin | Occurrence of a Relative Efficacy Response | Week 30 (N=93, 99, 50, 140, 151, 45) | 63.6 percentage of participants |
| Empagliflozin 25 mg + Metformin | Occurrence of a Relative Efficacy Response | Week 42 (N=85, 93, 46, 132, 140, 44) | 66.4 percentage of participants |
| Empagliflozin 25 mg + Metformin | Occurrence of a Relative Efficacy Response | Week 78 (N=72, 84, 42, 115, 121, 38) | 64.5 percentage of participants |
| Empagliflozin 25 mg + Metformin | Occurrence of a Relative Efficacy Response | Week 66 (N=80, 87, 43, 120, 127, 39) | 64.6 percentage of participants |
| Empagliflozin 25 mg + Metformin | Occurrence of a Relative Efficacy Response | Week 54 (N=78, 85, 44, 128, 136, 41) | 65.4 percentage of participants |
| Sitaglipin + Metformin | Occurrence of a Relative Efficacy Response | Week 66 (N=80, 87, 43, 120, 127, 39) | 66.7 percentage of participants |
| Sitaglipin + Metformin | Occurrence of a Relative Efficacy Response | Week 18 (N=93, 105, 53, 149, 157, 48) | 66.7 percentage of participants |
| Sitaglipin + Metformin | Occurrence of a Relative Efficacy Response | Week 6 (N=104, 108, 55, 162, 163, 54) | 63.0 percentage of participants |
| Sitaglipin + Metformin | Occurrence of a Relative Efficacy Response | Week 78 (N=72, 84, 42, 115, 121, 38) | 60.5 percentage of participants |
| Sitaglipin + Metformin | Occurrence of a Relative Efficacy Response | Week 42 (N=85, 93, 46, 132, 140, 44) | 54.5 percentage of participants |
| Sitaglipin + Metformin | Occurrence of a Relative Efficacy Response | Week 54 (N=78, 85, 44, 128, 136, 41) | 58.5 percentage of participants |
| Sitaglipin + Metformin | Occurrence of a Relative Efficacy Response | Week 30 (N=93, 99, 50, 140, 151, 45) | 68.9 percentage of participants |
Secondary
Occurrence of a Treat-to-target Response (HbA1c < 6.5%)
Occurrence of a Treat-to-target Response, defined as HbA1c \< 6.5% over time
Time frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78
Population: Treated set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Empagliflozin 10 mg | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 30 (N=93, 99, 50, 140, 151, 45) | 8.6 percentage of participants |
| Empagliflozin 10 mg | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 18 (N=93, 105, 53, 149, 157, 48) | 11.8 percentage of participants |
| Empagliflozin 10 mg | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 42 (N=85, 93, 46, 132, 140, 44) | 11.8 percentage of participants |
| Empagliflozin 10 mg | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 78 (N=72, 84, 42, 115, 121, 38) | 6.9 percentage of participants |
| Empagliflozin 10 mg | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 6 (N=104, 108, 55, 162, 163, 54) | 3.8 percentage of participants |
| Empagliflozin 10 mg | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 66 (N=80, 87, 43, 120, 127, 39) | 10.0 percentage of participants |
| Empagliflozin 10 mg | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 54 (N=78, 85, 44, 128, 136, 41) | 11.5 percentage of participants |
| Empagliflozin 25 mg | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 6 (N=104, 108, 55, 162, 163, 54) | 11.1 percentage of participants |
| Empagliflozin 25 mg | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 42 (N=85, 93, 46, 132, 140, 44) | 10.8 percentage of participants |
| Empagliflozin 25 mg | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 18 (N=93, 105, 53, 149, 157, 48) | 12.4 percentage of participants |
| Empagliflozin 25 mg | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 30 (N=93, 99, 50, 140, 151, 45) | 10.1 percentage of participants |
| Empagliflozin 25 mg | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 54 (N=78, 85, 44, 128, 136, 41) | 5.9 percentage of participants |
| Empagliflozin 25 mg | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 66 (N=80, 87, 43, 120, 127, 39) | 11.5 percentage of participants |
| Empagliflozin 25 mg | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 78 (N=72, 84, 42, 115, 121, 38) | 8.3 percentage of participants |
| Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 30 (N=93, 99, 50, 140, 151, 45) | 14.0 percentage of participants |
| Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 66 (N=80, 87, 43, 120, 127, 39) | 14.0 percentage of participants |
| Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 18 (N=93, 105, 53, 149, 157, 48) | 13.2 percentage of participants |
| Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 6 (N=104, 108, 55, 162, 163, 54) | 16.4 percentage of participants |
| Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 78 (N=72, 84, 42, 115, 121, 38) | 9.5 percentage of participants |
| Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 54 (N=78, 85, 44, 128, 136, 41) | 18.2 percentage of participants |
| Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 42 (N=85, 93, 46, 132, 140, 44) | 21.7 percentage of participants |
| Empagliflozin 10 mg + Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 54 (N=78, 85, 44, 128, 136, 41) | 10.9 percentage of participants |
| Empagliflozin 10 mg + Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 66 (N=80, 87, 43, 120, 127, 39) | 8.3 percentage of participants |
| Empagliflozin 10 mg + Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 30 (N=93, 99, 50, 140, 151, 45) | 8.6 percentage of participants |
| Empagliflozin 10 mg + Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 42 (N=85, 93, 46, 132, 140, 44) | 10.6 percentage of participants |
| Empagliflozin 10 mg + Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 18 (N=93, 105, 53, 149, 157, 48) | 4.7 percentage of participants |
| Empagliflozin 10 mg + Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 78 (N=72, 84, 42, 115, 121, 38) | 10.4 percentage of participants |
| Empagliflozin 10 mg + Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 6 (N=104, 108, 55, 162, 163, 54) | 6.2 percentage of participants |
| Empagliflozin 25 mg + Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 54 (N=78, 85, 44, 128, 136, 41) | 15.4 percentage of participants |
| Empagliflozin 25 mg + Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 42 (N=85, 93, 46, 132, 140, 44) | 21.4 percentage of participants |
| Empagliflozin 25 mg + Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 18 (N=93, 105, 53, 149, 157, 48) | 5.1 percentage of participants |
| Empagliflozin 25 mg + Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 30 (N=93, 99, 50, 140, 151, 45) | 10.6 percentage of participants |
| Empagliflozin 25 mg + Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 78 (N=72, 84, 42, 115, 121, 38) | 13.2 percentage of participants |
| Empagliflozin 25 mg + Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 66 (N=80, 87, 43, 120, 127, 39) | 12.6 percentage of participants |
| Empagliflozin 25 mg + Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 6 (N=104, 108, 55, 162, 163, 54) | 6.7 percentage of participants |
| Sitaglipin + Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 66 (N=80, 87, 43, 120, 127, 39) | 15.4 percentage of participants |
| Sitaglipin + Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 30 (N=93, 99, 50, 140, 151, 45) | 4.4 percentage of participants |
| Sitaglipin + Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 6 (N=104, 108, 55, 162, 163, 54) | 11.1 percentage of participants |
| Sitaglipin + Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 18 (N=93, 105, 53, 149, 157, 48) | 12.5 percentage of participants |
| Sitaglipin + Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 78 (N=72, 84, 42, 115, 121, 38) | 18.4 percentage of participants |
| Sitaglipin + Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 54 (N=78, 85, 44, 128, 136, 41) | 9.8 percentage of participants |
| Sitaglipin + Metformin | Occurrence of a Treat-to-target Response (HbA1c < 6.5%) | Week 42 (N=85, 93, 46, 132, 140, 44) | 9.1 percentage of participants |