Diabetes Mellitus, Type 2
Conditions
Brief summary
This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.
Interventions
DRUGBI 10773
BI 10773 tablets once daily
DRUGPlacebo
Placebo matching BI 10773 low dose
Sitagliptin once daily
Sponsors
Eli Lilly and Company
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients completing the entire treatment period of the preceding double-blind trial 1245.19, 1245.20 or 1245.23 with or without rescue therapy. 2. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice and local legislation.
Exclusion criteria
1. Patient who meet one or more of the withdrawal criteria of the treatment period of the previous trial 1245.19, 1245.20 or 1245.23. 2. Indication of liver disease, defined by serum levels of either alanine aminotransferase , aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during last visit of preceding trial. 3. Impaired renal function defined as glomerular filtration rate\<30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) as determined during last visit of preceding trial. 4. Contraindications to sitagliptin, pioglitazone, metformin or sulfonylurea according to local label, which started during trial participation in 1245.19, 1245.20 or 1245.23 5. Pre-menopausal women (last menstruation \< or = 1 year prior to informed consent) who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner. 6. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake. 7. Participation in another trial with an investigational drug within 30 days prior to informed consent (except 1245.19, 1245.20 and 1245.23). 8. Any other clinical condition that would jeopardize patient's safety while participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | Baseline and 52 weeks | Change from baseline in HbA1c after 52 weeks |
| Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment | Baseline and 76 weeks | Change from baseline in HbA1c after 76 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c (%) Changes From Baseline After 76 Weeks of Treatment | Baseline and 76 weeks | Change from baseline in HbA1c (%) after 76 weeks using MMRM approach |
| Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | Baseline and 52 weeks | Systolic blood pressure - change from baseline after 52 weeks of treatment |
| Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | Baseline and 76 weeks | Systolic blood pressure - change from baseline after 76 weeks of treatment |
| Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | Baseline and 52 weeks | Diastolic blood pressure - change from baseline after 52 weeks of treatment |
| Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment | Baseline and 76 weeks | Waist circumference (cm) - change from baseline after 76 weeks of treatment |
| Body Weight (kg) Change From Baseline After 52 Weeks of Treatment | Baseline and 52 weeks | Body Weight (kg) - Change From Baseline After 52 Weeks of Treatment |
| Body Weight (kg) Change From Baseline After 76 Weeks of Treatment | Baseline and 76 weeks | Body Weight (kg) - Change From Baseline After 76 Weeks of Treatment |
| Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment | Baseline and 52 weeks | Fasting plasma glucose - change from baseline after 52 weeks of treatment |
| Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment | Baseline and 76 weeks | Fasting plasma glucose - change from baseline after 76 weeks of treatment |
| Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | Baseline and 76 weeks | Diastolic blood pressure - change from baseline after 76 weeks of treatment |
| Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment | Baseline and 52 weeks | Waist circumference (cm) - change from baseline after 52 weeks of treatment |
Countries
Belgium, Canada, China, France, Germany, Greece, India, Ireland, Japan, Mexico, Philippines, Slovakia, Slovenia, South Korea, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Empagliflozin 10 mg (Drug Naive) Patients rolled over from trial 1245.20
Empagliflozin 10 mg tablets once daily
Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching Empagliflozin 25 mg | 224 |
| Empagliflozin 25 mg (Drug Naive) Patients rolled over from trial 1245.20
Empagliflozin 25 mg tablets once daily
Placebo: Placebo matching Sitagliptin
Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily
Placebo: Placebo matching Empagliflozin 10 mg | 224 |
| Placebo (Drug Naive) Patients rolled over from trial 1245.20
Placebo tablets matching Empagliflozin / Sitagliptin once daily
Placebo: Placebo matching Empagliflozin 10 mg
Placebo: Placebo matching Sitagliptin
Placebo: Placebo matching Empagliflozin 25 mg | 228 |
| Sitagliptin 100 mg (Drug Naive) Patients rolled over from trial 1245.20
Sitagliptin once daily
Placebo: Placebo matching Empagliflozin 25 mg
Placebo: Placebo matching Empagliflozin 10 mg
Sitagliptin 100 mg: Sitagliptin once daily | 223 |
| Empagliflozin 10 mg (Pioglitazone) Patients rolled over from trial 1245.19
Empagliflozin 10 mg tablets once daily
Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily
Placebo: Placebo matching Empagliflozin 25 mg | 165 |
| Empagliflozin 25 mg (Pioglitazone) Patients rolled over from trial 1245.19
Empagliflozin 25 mg tablets once daily
Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily
Placebo: Placebo matching Empagliflozin 10 mg | 168 |
| Placebo (Pioglitazone) Patients rolled over from trial 1245.19
Placebo tablets matching Empagliflozin once daily
Placebo: Placebo matching Empagliflozin 10 mg
Placebo: Placebo matching Empagliflozin 25 mg | 165 |
| Empagliflozin 10 mg (Metformin) Patients rolled over from trial 1245.23
Empagliflozin 10 mg tablets once daily
Placebo: Placebo matching Empagliflozin 25 mg
Empagliflozin 10 mg: Empagliflozin 10 mg once daily | 217 |
| Empagliflozin 25 mg (Metformin) Patients rolled over from trial 1245.23
Empagliflozin 25 mg tablets once daily
Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily
Placebo: Placebo matching Empagliflozin 10 mg | 213 |
| Placebo (Metformin) Patients rolled over from trial 1245.23
Placebo tablets matching Empagliflozin once daily
Placebo: Placebo matching Empagliflozin 10 mg
Placebo: Placebo matching Empagliflozin 25 mg | 207 |
| Empagliflozin 10 mg (Metformin+Sulfonylurea) Patients rolled over from trial 1245.23
Empagliflozin 10 mg tablets once daily
Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily
Placebo: Placebo matching Empagliflozin 25 mg | 225 |
| Empagliflozin 25 mg (Metformin+Sulfonylurea) Patients rolled over from trial 1245.23
Empagliflozin 25 mg tablets once daily
Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily
Placebo: Placebo matching Empagliflozin 10 mg | 216 |
| Placebo (Metformin+Sulfonylurea) Patients rolled over from trial 1245.23
Placebo tablets matching Empagliflozin
Placebo: Placebo matching Empagliflozin 10 mg
Placebo: Placebo matching Empagliflozin 25 mg | 225 |
| Total | 2,700 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | did not continue in extension | 41 | 45 | 51 | 51 | 48 | 50 | 54 | 36 | 44 | 48 | 45 | 34 | 56 |
| Overall Study | discontinued in preceding trial | 18 | 20 | 41 | 17 | 11 | 12 | 18 | 8 | 17 | 21 | 17 | 17 | 24 |
| Overall Study | Lost to Follow-up | 3 | 2 | 5 | 5 | 3 | 4 | 2 | 2 | 1 | 4 | 2 | 1 | 2 |
| Overall Study | Not treated | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 15 | 14 | 12 | 13 | 8 | 7 | 13 | 9 | 12 | 13 | 11 | 13 | 16 |
Baseline characteristics
| Characteristic | Empagliflozin 10 mg (Drug Naive) | Empagliflozin 25 mg (Drug Naive) | Placebo (Drug Naive) | Sitagliptin 100 mg (Drug Naive) | Empagliflozin 10 mg (Pioglitazone) | Empagliflozin 25 mg (Pioglitazone) | Placebo (Pioglitazone) | Empagliflozin 10 mg (Metformin) | Empagliflozin 25 mg (Metformin) | Placebo (Metformin) | Empagliflozin 10 mg (Metformin+Sulfonylurea) | Empagliflozin 25 mg (Metformin+Sulfonylurea) | Placebo (Metformin+Sulfonylurea) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 56.2 years STANDARD_DEVIATION 11.6 | 53.8 years STANDARD_DEVIATION 11.6 | 54.9 years STANDARD_DEVIATION 10.9 | 55.1 years STANDARD_DEVIATION 9.9 | 54.7 years STANDARD_DEVIATION 9.9 | 54.2 years STANDARD_DEVIATION 8.9 | 54.6 years STANDARD_DEVIATION 10.5 | 55.5 years STANDARD_DEVIATION 9.9 | 55.6 years STANDARD_DEVIATION 10.2 | 56.0 years STANDARD_DEVIATION 9.7 | 57.0 years STANDARD_DEVIATION 9.2 | 57.4 years STANDARD_DEVIATION 9.3 | 56.9 years STANDARD_DEVIATION 9.2 | 55.6 years STANDARD_DEVIATION 10.2 |
| Sex: Female, Male Female | 82 Participants | 79 Participants | 105 Participants | 82 Participants | 82 Participants | 83 Participants | 92 Participants | 92 Participants | 93 Participants | 91 Participants | 112 Participants | 102 Participants | 113 Participants | 1208 Participants |
| Sex: Female, Male Male | 142 Participants | 145 Participants | 123 Participants | 141 Participants | 83 Participants | 85 Participants | 73 Participants | 125 Participants | 120 Participants | 116 Participants | 113 Participants | 114 Participants | 112 Participants | 1492 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 | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 134 / 229 | 110 / 224 | 92 / 223 | 116 / 223 | 110 / 165 | 96 / 165 | 107 / 168 | 122 / 206 | 113 / 217 | 106 / 214 | 146 / 225 | 147 / 224 | 142 / 217 |
| serious Total, serious adverse events | 23 / 229 | 25 / 224 | 16 / 223 | 18 / 223 | 11 / 165 | 13 / 165 | 15 / 168 | 24 / 206 | 19 / 217 | 17 / 214 | 31 / 225 | 29 / 224 | 24 / 217 |
Outcome results
Primary
Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment
Change from baseline in HbA1c after 52 weeks
Time frame: Baseline and 52 weeks
Population: Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial.~(LOCF:Last observation carried forward)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BI 10773 Low (Drug Naive) | Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | -0.70 % of HbA1c | Standard Error 0.05 |
| BI 10773 High (Drug Naive) | Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | -0.82 % of HbA1c | Standard Error 0.05 |
| Placebo (Drug Naive) | Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | 0.09 % of HbA1c | Standard Error 0.05 |
| Sitagliptin 100mg (Drug Naive) | Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | -0.58 % of HbA1c | Standard Error 0.05 |
| BI 10773 Low (Pioglitazone) | Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | -0.63 % of HbA1c | Standard Error 0.07 |
| BI 10773 High (Pioglitazone) | Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | -0.71 % of HbA1c | Standard Error 0.07 |
| Placebo (Pioglitazone) | Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | -0.03 % of HbA1c | Standard Error 0.07 |
| BI 10773 Low (Metformin) | Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | -0.69 % of HbA1c | Standard Error 0.05 |
| BI 10773 High (Metformin) | Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | -0.76 % of HbA1c | Standard Error 0.05 |
| Placebo (Metformin) | Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | -0.07 % of HbA1c | Standard Error 0.05 |
| BI 10773 Low (Metformin+Sulfonylurea) | Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | -0.78 % of HbA1c | Standard Error 0.05 |
| BI 10773 High (Metformin+Sulfonylurea) | Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | -0.74 % of HbA1c | Standard Error 0.05 |
| Placebo (Metformin+Sulfonylurea) | Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | -0.04 % of HbA1c | Standard Error 0.05 |
Comparison: statistical analysis at week 52p-value: <0.000195% CI: [-0.94, -0.64]ANCOVA
Comparison: statistical analysis at week 52p-value: <0.000195% CI: [-1.06, -0.76]ANCOVA
Comparison: statistical analysis at week 52p-value: <0.000195% CI: [-0.82, -0.52]ANCOVA
Comparison: statistical analysis at week 52p-value: 0.124595% CI: [-0.27, 0.03]ANCOVA
Comparison: statistical analysis at week 52p-value: 0.002295% CI: [-0.39, -0.09]ANCOVA
p-value: <0.000195% CI: [-0.79, -0.41]ANCOVA
p-value: <0.000195% CI: [-0.87, -0.49]ANCOVA
p-value: <0.000195% CI: [-0.75, -0.48]ANCOVA
p-value: <0.000195% CI: [-0.83, -0.55]ANCOVA
p-value: <0.000195% CI: [-0.89, -0.59]ANCOVA
p-value: <0.000195% CI: [-0.85, -0.55]ANCOVA
Primary
Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment
Change from baseline in HbA1c after 76 weeks
Time frame: Baseline and 76 weeks
Population: Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial. (LOCF)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BI 10773 Low (Drug Naive) | Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment | -0.65 % of HbA1c | Standard Deviation 0.06 |
| BI 10773 High (Drug Naive) | Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment | -0.76 % of HbA1c | Standard Deviation 0.06 |
| Placebo (Drug Naive) | Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment | 0.13 % of HbA1c | Standard Deviation 0.06 |
| Sitagliptin 100mg (Drug Naive) | Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment | -0.53 % of HbA1c | Standard Deviation 0.06 |
| BI 10773 Low (Pioglitazone) | Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment | -0.61 % of HbA1c | Standard Deviation 0.07 |
| BI 10773 High (Pioglitazone) | Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment | -0.70 % of HbA1c | Standard Deviation 0.07 |
| Placebo (Pioglitazone) | Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment | -0.01 % of HbA1c | Standard Deviation 0.07 |
| BI 10773 Low (Metformin) | Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment | -0.62 % of HbA1c | Standard Deviation 0.05 |
| BI 10773 High (Metformin) | Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment | -0.74 % of HbA1c | Standard Deviation 0.05 |
| Placebo (Metformin) | Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment | -0.01 % of HbA1c | Standard Deviation 0.05 |
| BI 10773 Low (Metformin+Sulfonylurea) | Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment | -0.74 % of HbA1c | Standard Deviation 0.06 |
| BI 10773 High (Metformin+Sulfonylurea) | Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment | -0.72 % of HbA1c | Standard Deviation 0.06 |
| Placebo (Metformin+Sulfonylurea) | Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment | -0.03 % of HbA1c | Standard Deviation 0.06 |
p-value: <0.000195% CI: [-0.94, -0.63]ANCOVA
p-value: <0.000195% CI: [-1.04, -0.73]ANCOVA
p-value: <0.000195% CI: [-0.82, -0.51]ANCOVA
p-value: 0.13195% CI: [-0.28, 0.04]ANCOVA
p-value: 0.00595% CI: [-0.38, -0.07]ANCOVA
p-value: <0.000195% CI: [-0.79, -0.4]ANCOVA
p-value: <0.000195% CI: [-0.88, -0.5]ANCOVA
p-value: <0.000195% CI: [-0.75, -0.46]ANCOVA
p-value: <0.000195% CI: [-0.88, -0.58]ANCOVA
p-value: <0.000195% CI: [-0.87, -0.56]ANCOVA
p-value: <0.000195% CI: [-0.85, -0.53]ANCOVA
Secondary
Body Weight (kg) Change From Baseline After 52 Weeks of Treatment
Body Weight (kg) - Change From Baseline After 52 Weeks of Treatment
Time frame: Baseline and 52 weeks
Population: Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline body weight assessment, irrespective of participation in the extension trial. - LOCF
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BI 10773 Low (Drug Naive) | Body Weight (kg) Change From Baseline After 52 Weeks of Treatment | -2.70 kg | Standard Error 0.19 |
| BI 10773 High (Drug Naive) | Body Weight (kg) Change From Baseline After 52 Weeks of Treatment | -2.61 kg | Standard Error 0.19 |
| Placebo (Drug Naive) | Body Weight (kg) Change From Baseline After 52 Weeks of Treatment | -0.48 kg | Standard Error 0.19 |
| Sitagliptin 100mg (Drug Naive) | Body Weight (kg) Change From Baseline After 52 Weeks of Treatment | 0.14 kg | Standard Error 0.19 |
| BI 10773 Low (Pioglitazone) | Body Weight (kg) Change From Baseline After 52 Weeks of Treatment | -1.50 kg | Standard Error 0.24 |
| BI 10773 High (Pioglitazone) | Body Weight (kg) Change From Baseline After 52 Weeks of Treatment | -1.40 kg | Standard Error 0.24 |
| Placebo (Pioglitazone) | Body Weight (kg) Change From Baseline After 52 Weeks of Treatment | 0.59 kg | Standard Error 0.24 |
| BI 10773 Low (Metformin) | Body Weight (kg) Change From Baseline After 52 Weeks of Treatment | -2.27 kg | Standard Error 0.19 |
| BI 10773 High (Metformin) | Body Weight (kg) Change From Baseline After 52 Weeks of Treatment | -2.84 kg | Standard Error 0.19 |
| Placebo (Metformin) | Body Weight (kg) Change From Baseline After 52 Weeks of Treatment | -0.54 kg | Standard Error 0.2 |
| BI 10773 Low (Metformin+Sulfonylurea) | Body Weight (kg) Change From Baseline After 52 Weeks of Treatment | -2.28 kg | Standard Error 0.18 |
| BI 10773 High (Metformin+Sulfonylurea) | Body Weight (kg) Change From Baseline After 52 Weeks of Treatment | -2.32 kg | Standard Error 0.19 |
| Placebo (Metformin+Sulfonylurea) | Body Weight (kg) Change From Baseline After 52 Weeks of Treatment | -0.31 kg | Standard Error 0.18 |
p-value: <0.000195% CI: [-2.75, -1.69]ANCOVA
p-value: <0.000195% CI: [-2.66, -1.61]ANCOVA
p-value: 0.022395% CI: [0.09, 1.14]ANCOVA
p-value: <0.000195% CI: [-3.37, -2.31]ANCOVA
p-value: <0.000195% CI: [-3.28, -2.22]ANCOVA
p-value: <0.000195% CI: [-2.76, -1.41]ANCOVA
p-value: <0.000195% CI: [-2.66, -1.32]ANCOVA
p-value: <0.000195% CI: [-2.27, -1.19]ANCOVA
p-value: <0.000195% CI: [-2.85, -1.76]ANCOVA
p-value: <0.000195% CI: [-2.48, -1.47]ANCOVA
p-value: <0.000195% CI: [-2.52, -1.5]ANCOVA
Secondary
Body Weight (kg) Change From Baseline After 76 Weeks of Treatment
Body Weight (kg) - Change From Baseline After 76 Weeks of Treatment
Time frame: Baseline and 76 weeks
Population: Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline body weight assessment, irrespective of participation in the extension trial -LOCF
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BI 10773 Low (Drug Naive) | Body Weight (kg) Change From Baseline After 76 Weeks of Treatment | -2.24 kg | Standard Error 0.2 |
| BI 10773 High (Drug Naive) | Body Weight (kg) Change From Baseline After 76 Weeks of Treatment | -2.45 kg | Standard Error 0.2 |
| Placebo (Drug Naive) | Body Weight (kg) Change From Baseline After 76 Weeks of Treatment | -0.43 kg | Standard Error 0.2 |
| Sitagliptin 100mg (Drug Naive) | Body Weight (kg) Change From Baseline After 76 Weeks of Treatment | 0.10 kg | Standard Error 0.2 |
| BI 10773 Low (Pioglitazone) | Body Weight (kg) Change From Baseline After 76 Weeks of Treatment | -1.47 kg | Standard Error 0.26 |
| BI 10773 High (Pioglitazone) | Body Weight (kg) Change From Baseline After 76 Weeks of Treatment | -1.21 kg | Standard Error 0.26 |
| Placebo (Pioglitazone) | Body Weight (kg) Change From Baseline After 76 Weeks of Treatment | 0.50 kg | Standard Error 0.26 |
| BI 10773 Low (Metformin) | Body Weight (kg) Change From Baseline After 76 Weeks of Treatment | -2.39 kg | Standard Error 0.21 |
| BI 10773 High (Metformin) | Body Weight (kg) Change From Baseline After 76 Weeks of Treatment | -2.65 kg | Standard Error 0.22 |
| Placebo (Metformin) | Body Weight (kg) Change From Baseline After 76 Weeks of Treatment | -0.46 kg | Standard Error 0.22 |
| BI 10773 Low (Metformin+Sulfonylurea) | Body Weight (kg) Change From Baseline After 76 Weeks of Treatment | -2.44 kg | Standard Error 0.19 |
| BI 10773 High (Metformin+Sulfonylurea) | Body Weight (kg) Change From Baseline After 76 Weeks of Treatment | -2.28 kg | Standard Error 0.2 |
| Placebo (Metformin+Sulfonylurea) | Body Weight (kg) Change From Baseline After 76 Weeks of Treatment | -0.63 kg | Standard Error 0.19 |
p-value: <0.000195% CI: [-2.35, -1.26]ANCOVA
p-value: <0.000195% CI: [-2.56, -1.48]ANCOVA
p-value: 0.054695% CI: [-0.01, 1.08]ANCOVA
p-value: <0.000195% CI: [-2.89, -1.8]ANCOVA
p-value: <0.000195% CI: [-3.1, -2.01]ANCOVA
p-value: <0.000195% CI: [-2.69, -1.24]ANCOVA
p-value: <0.000195% CI: [-2.43, -0.99]ANCOVA
p-value: <0.000195% CI: [-2.52, -1.34]ANCOVA
p-value: <0.000195% CI: [-2.79, -1.6]ANCOVA
p-value: <0.000195% CI: [-2.34, -1.27]ANCOVA
p-value: <0.000195% CI: [-2.18, -1.11]ANCOVA
Secondary
Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Diastolic blood pressure - change from baseline after 52 weeks of treatment
Time frame: Baseline and 52 weeks
Population: Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline diastolic blood pressure assessment, irrespective of participation in the extension trial -LOCF
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BI 10773 Low (Drug Naive) | Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -1.3 mmHg | Standard Error 0.5 |
| BI 10773 High (Drug Naive) | Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -1.9 mmHg | Standard Error 0.5 |
| Placebo (Drug Naive) | Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -0.2 mmHg | Standard Error 0.5 |
| Sitagliptin 100mg (Drug Naive) | Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -0.3 mmHg | Standard Error 0.5 |
| BI 10773 Low (Pioglitazone) | Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -1.6 mmHg | Standard Error 0.5 |
| BI 10773 High (Pioglitazone) | Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -2.2 mmHg | Standard Error 0.5 |
| Placebo (Pioglitazone) | Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | 0.4 mmHg | Standard Error 0.5 |
| BI 10773 Low (Metformin) | Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -2.2 mmHg | Standard Error 0.5 |
| BI 10773 High (Metformin) | Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -2.1 mmHg | Standard Error 0.5 |
| Placebo (Metformin) | Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -0.4 mmHg | Standard Error 0.5 |
| BI 10773 Low (Metformin+Sulfonylurea) | Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -1.7 mmHg | Standard Error 0.5 |
| BI 10773 High (Metformin+Sulfonylurea) | Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -1.6 mmHg | Standard Error 0.5 |
| Placebo (Metformin+Sulfonylurea) | Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -1.0 mmHg | Standard Error 0.5 |
p-value: 0.105895% CI: [-2.4, 0.2]ANCOVA
p-value: 0.010995% CI: [-3.1, -0.4]ANCOVA
p-value: 0.825995% CI: [-1.5, 1.2]ANCOVA
p-value: 0.16695% CI: [-2.3, 0.4]ANCOVA
p-value: 0.021295% CI: [-2.9, -0.2]ANCOVA
p-value: 0.007695% CI: [-3.4, -0.5]ANCOVA
p-value: 0.000395% CI: [-4.1, -1.2]ANCOVA
p-value: 0.01795% CI: [-3.2, -0.3]ANCOVA
p-value: 0.023695% CI: [-3.1, -0.2]ANCOVA
p-value: 0.252395% CI: [-2, 0.5]ANCOVA
p-value: 0.349495% CI: [-1.9, 0.7]ANCOVA
Secondary
Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Diastolic blood pressure - change from baseline after 76 weeks of treatment
Time frame: Baseline and 76 weeks
Population: Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline diastolic blood pressure assessment, irrespective of participation in the extension trial -LOCF
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BI 10773 Low (Drug Naive) | Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -1.6 mmHg | Standard Error 0.5 |
| BI 10773 High (Drug Naive) | Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -1.6 mmHg | Standard Error 0.5 |
| Placebo (Drug Naive) | Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -0.6 mmHg | Standard Error 0.5 |
| Sitagliptin 100mg (Drug Naive) | Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -0.1 mmHg | Standard Error 0.5 |
| BI 10773 Low (Pioglitazone) | Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -1.3 mmHg | Standard Error 0.5 |
| BI 10773 High (Pioglitazone) | Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -2.0 mmHg | Standard Error 0.5 |
| Placebo (Pioglitazone) | Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | 0.2 mmHg | Standard Error 0.5 |
| BI 10773 Low (Metformin) | Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -2.5 mmHg | Standard Error 0.5 |
| BI 10773 High (Metformin) | Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -1.9 mmHg | Standard Error 0.5 |
| Placebo (Metformin) | Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -0.5 mmHg | Standard Error 0.5 |
| BI 10773 Low (Metformin+Sulfonylurea) | Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -2.6 mmHg | Standard Error 0.5 |
| BI 10773 High (Metformin+Sulfonylurea) | Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -2.3 mmHg | Standard Error 0.5 |
| Placebo (Metformin+Sulfonylurea) | Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -1.4 mmHg | Standard Error 0.5 |
p-value: 0.156895% CI: [-2.3, 0.4]ANCOVA
p-value: 0.132395% CI: [-2.4, 0.3]ANCOVA
p-value: 0.432795% CI: [-0.8, 1.9]ANCOVA
p-value: 0.028995% CI: [-2.8, -0.2]ANCOVA
p-value: 0.023195% CI: [-2.9, -0.2]ANCOVA
p-value: 0.051395% CI: [-3, 0]ANCOVA
p-value: 0.003895% CI: [-3.7, -0.7]ANCOVA
p-value: 0.008495% CI: [-3.4, -0.5]ANCOVA
p-value: 0.067795% CI: [-2.8, 0.1]ANCOVA
p-value: 0.081495% CI: [-2.4, 0.1]ANCOVA
p-value: 0.178595% CI: [-2.2, 0.4]ANCOVA
Secondary
Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment
Fasting plasma glucose - change from baseline after 52 weeks of treatment
Time frame: Baseline and 52 weeks
Population: Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline fasting plasma glucose assessment, irrespective of participation in the extension trial -LOCF
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BI 10773 Low (Drug Naive) | Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment | -18.9 mg/dL | Standard Error 2 |
| BI 10773 High (Drug Naive) | Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment | -23.9 mg/dL | Standard Error 2 |
| Placebo (Drug Naive) | Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment | 13.3 mg/dL | Standard Error 2 |
| Sitagliptin 100mg (Drug Naive) | Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment | -3.9 mg/dL | Standard Error 2 |
| BI 10773 Low (Pioglitazone) | Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment | -16.7 mg/dL | Standard Error 2.8 |
| BI 10773 High (Pioglitazone) | Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment | -20.7 mg/dL | Standard Error 2.8 |
| Placebo (Pioglitazone) | Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment | 10.3 mg/dL | Standard Error 2.8 |
| BI 10773 Low (Metformin) | Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment | -16.7 mg/dL | Standard Error 1.9 |
| BI 10773 High (Metformin) | Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment | -19.7 mg/dL | Standard Error 1.9 |
| Placebo (Metformin) | Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment | 7.6 mg/dL | Standard Error 2 |
| BI 10773 Low (Metformin+Sulfonylurea) | Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment | -18.4 mg/dL | Standard Error 2.1 |
| BI 10773 High (Metformin+Sulfonylurea) | Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment | -19.3 mg/dL | Standard Error 2.1 |
| Placebo (Metformin+Sulfonylurea) | Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment | 9.4 mg/dL | Standard Error 2.1 |
p-value: <0.000195% CI: [-37.8, -26.7]ANCOVA
p-value: <0.000195% CI: [-42.8, -31.7]ANCOVA
p-value: <0.000195% CI: [-22.9, -11.7]ANCOVA
p-value: <0.000195% CI: [-20.6, -9.4]ANCOVA
p-value: <0.000195% CI: [-25.5, -14.4]ANCOVA
p-value: <0.000195% CI: [-35, -19.2]ANCOVA
p-value: <0.000195% CI: [-38.9, -23.2]ANCOVA
p-value: <0.000195% CI: [-29.7, -18.9]ANCOVA
p-value: <0.000195% CI: [-32.7, -21.9]ANCOVA
p-value: <0.000195% CI: [-33.6, -22]ANCOVA
p-value: <0.000195% CI: [-34.5, -22.8]ANCOVA
Secondary
Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment
Fasting plasma glucose - change from baseline after 76 weeks of treatment
Time frame: Baseline and 76 weeks
Population: Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline fasting plasma glucose assessment, irrespective of participation in the extension trial -LOCF
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BI 10773 Low (Drug Naive) | Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment | -17.2 mg/dL | Standard Error 2.1 |
| BI 10773 High (Drug Naive) | Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment | -20.4 mg/dL | Standard Error 2.1 |
| Placebo (Drug Naive) | Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment | 14.4 mg/dL | Standard Error 2.1 |
| Sitagliptin 100mg (Drug Naive) | Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment | -1.8 mg/dL | Standard Error 2.1 |
| BI 10773 Low (Pioglitazone) | Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment | -13.9 mg/dL | Standard Error 2.9 |
| BI 10773 High (Pioglitazone) | Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment | -18.0 mg/dL | Standard Error 2.9 |
| Placebo (Pioglitazone) | Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment | 9.4 mg/dL | Standard Error 2.9 |
| BI 10773 Low (Metformin) | Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment | -14.5 mg/dL | Standard Error 2 |
| BI 10773 High (Metformin) | Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment | -20.9 mg/dL | Standard Error 2 |
| Placebo (Metformin) | Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment | 10.5 mg/dL | Standard Error 2 |
| BI 10773 Low (Metformin+Sulfonylurea) | Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment | -19.5 mg/dL | Standard Error 2.2 |
| BI 10773 High (Metformin+Sulfonylurea) | Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment | -20.4 mg/dL | Standard Error 2.2 |
| Placebo (Metformin+Sulfonylurea) | Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment | 11.4 mg/dL | Standard Error 2.2 |
p-value: <0.000195% CI: [-37.4, -25.9]ANCOVA
p-value: <0.000195% CI: [-40.7, -29.1]ANCOVA
p-value: <0.000195% CI: [-22.1, -10.5]ANCOVA
p-value: <0.000195% CI: [-21.2, -9.6]ANCOVA
p-value: <0.000195% CI: [-24.5, -12.8]ANCOVA
p-value: <0.000195% CI: [-31.4, -15.3]ANCOVA
p-value: <0.000195% CI: [-35.4, -19.4]ANCOVA
p-value: <0.000195% CI: [-30.5, -19.6]ANCOVA
p-value: <0.000195% CI: [-36.9, -25.9]ANCOVA
p-value: <0.000195% CI: [-37, -24.9]ANCOVA
p-value: <0.000195% CI: [-37.9, -25.7]ANCOVA
Secondary
HbA1c (%) Changes From Baseline After 76 Weeks of Treatment
Change from baseline in HbA1c (%) after 76 weeks using MMRM approach
Time frame: Baseline and 76 weeks
Population: Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial. (OC: Observed cases)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BI 10773 Low (Drug Naive) | HbA1c (%) Changes From Baseline After 76 Weeks of Treatment | -0.70 % of HbA1c | Standard Error 0.07 |
| BI 10773 High (Drug Naive) | HbA1c (%) Changes From Baseline After 76 Weeks of Treatment | -0.77 % of HbA1c | Standard Error 0.07 |
| Placebo (Drug Naive) | HbA1c (%) Changes From Baseline After 76 Weeks of Treatment | 0.13 % of HbA1c | Standard Error 0.08 |
| Sitagliptin 100mg (Drug Naive) | HbA1c (%) Changes From Baseline After 76 Weeks of Treatment | -0.48 % of HbA1c | Standard Error 0.07 |
| BI 10773 Low (Pioglitazone) | HbA1c (%) Changes From Baseline After 76 Weeks of Treatment | -0.67 % of HbA1c | Standard Error 0.09 |
| BI 10773 High (Pioglitazone) | HbA1c (%) Changes From Baseline After 76 Weeks of Treatment | -0.77 % of HbA1c | Standard Error 0.08 |
| Placebo (Pioglitazone) | HbA1c (%) Changes From Baseline After 76 Weeks of Treatment | -0.05 % of HbA1c | Standard Error 0.12 |
| BI 10773 Low (Metformin) | HbA1c (%) Changes From Baseline After 76 Weeks of Treatment | -0.60 % of HbA1c | Standard Error 0.06 |
| BI 10773 High (Metformin) | HbA1c (%) Changes From Baseline After 76 Weeks of Treatment | -0.76 % of HbA1c | Standard Error 0.07 |
| Placebo (Metformin) | HbA1c (%) Changes From Baseline After 76 Weeks of Treatment | 0.07 % of HbA1c | Standard Error 0.08 |
| BI 10773 Low (Metformin+Sulfonylurea) | HbA1c (%) Changes From Baseline After 76 Weeks of Treatment | -0.75 % of HbA1c | Standard Error 0.08 |
| BI 10773 High (Metformin+Sulfonylurea) | HbA1c (%) Changes From Baseline After 76 Weeks of Treatment | -0.75 % of HbA1c | Standard Error 0.08 |
| Placebo (Metformin+Sulfonylurea) | HbA1c (%) Changes From Baseline After 76 Weeks of Treatment | 0.06 % of HbA1c | Standard Error 0.09 |
p-value: <0.000195% CI: [-1.04, -0.61]Mixed Models Analysis
p-value: <0.000195% CI: [-1.11, -0.69]Mixed Models Analysis
p-value: 0.032295% CI: [-0.41, -0.02]Mixed Models Analysis
p-value: 0.003895% CI: [-0.48, -0.09]Mixed Models Analysis
p-value: <0.000195% CI: [-0.83, -0.4]Mixed Models Analysis
p-value: <0.000195% CI: [-0.9, -0.33]Mixed Models Analysis
p-value: <0.000195% CI: [-1, -0.44]Mixed Models Analysis
p-value: <0.000195% CI: [-0.87, -0.47]Mixed Models Analysis
p-value: <0.000195% CI: [-1.04, -0.63]Mixed Models Analysis
p-value: <0.000195% CI: [-1.04, -0.57]Mixed Models Analysis
p-value: <0.000195% CI: [-1.04, -0.56]Mixed Models Analysis
Secondary
Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment
Systolic blood pressure - change from baseline after 52 weeks of treatment
Time frame: Baseline and 52 weeks
Population: Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline systolic blood pressure assessment, irrespective of participation in the extension trial. (LOCF)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BI 10773 Low (Drug Naive) | Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -4.9 mmHg | Standard Error 0.8 |
| BI 10773 High (Drug Naive) | Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -4.5 mmHg | Standard Error 0.8 |
| Placebo (Drug Naive) | Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -1.6 mmHg | Standard Error 0.8 |
| Sitagliptin 100mg (Drug Naive) | Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -0.2 mmHg | Standard Error 0.8 |
| BI 10773 Low (Pioglitazone) | Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -1.8 mmHg | Standard Error 0.9 |
| BI 10773 High (Pioglitazone) | Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -3.3 mmHg | Standard Error 0.9 |
| Placebo (Pioglitazone) | Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | 0.6 mmHg | Standard Error 0.9 |
| BI 10773 Low (Metformin) | Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -3.6 mmHg | Standard Error 0.7 |
| BI 10773 High (Metformin) | Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -5.2 mmHg | Standard Error 0.7 |
| Placebo (Metformin) | Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -0.7 mmHg | Standard Error 0.7 |
| BI 10773 Low (Metformin+Sulfonylurea) | Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -3.1 mmHg | Standard Error 0.7 |
| BI 10773 High (Metformin+Sulfonylurea) | Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -2.7 mmHg | Standard Error 0.7 |
| Placebo (Metformin+Sulfonylurea) | Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | -0.2 mmHg | Standard Error 0.7 |
p-value: <0.000195% CI: [-6.8, -2.5]ANCOVA
p-value: 0.000195% CI: [-6.4, -2.1]ANCOVA
p-value: 0.210795% CI: [-3.5, 0.8]ANCOVA
p-value: 0.003395% CI: [-5.4, -1.1]ANCOVA
p-value: 0.010595% CI: [-5, -0.7]ANCOVA
p-value: 0.054395% CI: [-4.9, 0]ANCOVA
p-value: 0.001995% CI: [-6.4, -1.5]ANCOVA
p-value: 0.004595% CI: [-5, -0.9]ANCOVA
p-value: <0.000195% CI: [-6.6, -2.5]ANCOVA
p-value: 0.003195% CI: [-4.8, -1]ANCOVA
p-value: 0.009695% CI: [-4.4, -0.6]ANCOVA
Secondary
Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment
Systolic blood pressure - change from baseline after 76 weeks of treatment
Time frame: Baseline and 76 weeks
Population: Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline systolic blood pressure assessment, irrespective of participation in the extension trial -LOCF
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BI 10773 Low (Drug Naive) | Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -4.1 mmHg | Standard Error 0.8 |
| BI 10773 High (Drug Naive) | Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -4.2 mmHg | Standard Error 0.8 |
| Placebo (Drug Naive) | Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -0.7 mmHg | Standard Error 0.8 |
| Sitagliptin 100mg (Drug Naive) | Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -0.3 mmHg | Standard Error 0.8 |
| BI 10773 Low (Pioglitazone) | Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -1.7 mmHg | Standard Error 0.9 |
| BI 10773 High (Pioglitazone) | Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -3.4 mmHg | Standard Error 0.9 |
| Placebo (Pioglitazone) | Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | 0.3 mmHg | Standard Error 0.9 |
| BI 10773 Low (Metformin) | Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -5.2 mmHg | Standard Error 0.8 |
| BI 10773 High (Metformin) | Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -4.5 mmHg | Standard Error 0.8 |
| Placebo (Metformin) | Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -0.8 mmHg | Standard Error 0.8 |
| BI 10773 Low (Metformin+Sulfonylurea) | Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -3.8 mmHg | Standard Error 0.7 |
| BI 10773 High (Metformin+Sulfonylurea) | Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -3.7 mmHg | Standard Error 0.7 |
| Placebo (Metformin+Sulfonylurea) | Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | -1.6 mmHg | Standard Error 0.7 |
p-value: 0.002595% CI: [-5.5, -1.2]ANCOVA
p-value: 0.002195% CI: [-5.6, -1.2]ANCOVA
p-value: 0.724195% CI: [-1.8, 2.6]ANCOVA
p-value: 0.000895% CI: [-5.9, -1.6]ANCOVA
p-value: 0.000795% CI: [-6, -1.6]ANCOVA
p-value: 0.098795% CI: [-4.5, 0.4]ANCOVA
p-value: 0.002895% CI: [-6.1, -1.3]ANCOVA
p-value: <0.000195% CI: [-6.6, -2.3]ANCOVA
p-value: 0.000895% CI: [-5.9, -1.5]ANCOVA
p-value: 0.021395% CI: [-4.1, -0.3]ANCOVA
p-value: 0.028895% CI: [-4.1, -0.2]ANCOVA
Secondary
Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment
Waist circumference (cm) - change from baseline after 52 weeks of treatment
Time frame: Baseline and 52 weeks
Population: Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline waist circumference assessment, irrespective of participation in the extension trial -LOCF
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BI 10773 Low (Drug Naive) | Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment | -2.0 cm | Standard Error 0.4 |
| BI 10773 High (Drug Naive) | Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment | -1.7 cm | Standard Error 0.4 |
| Placebo (Drug Naive) | Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment | 0.1 cm | Standard Error 0.4 |
| Sitagliptin 100mg (Drug Naive) | Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment | 0.4 cm | Standard Error 0.4 |
| BI 10773 Low (Pioglitazone) | Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment | -1.5 cm | Standard Error 0.4 |
| BI 10773 High (Pioglitazone) | Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment | -1.1 cm | Standard Error 0.4 |
| Placebo (Pioglitazone) | Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment | -0.1 cm | Standard Error 0.4 |
| BI 10773 Low (Metformin) | Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment | -1.5 cm | Standard Error 0.3 |
| BI 10773 High (Metformin) | Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment | -2.0 cm | Standard Error 0.3 |
| Placebo (Metformin) | Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment | -0.4 cm | Standard Error 0.3 |
| BI 10773 Low (Metformin+Sulfonylurea) | Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment | -1.5 cm | Standard Error 0.3 |
| BI 10773 High (Metformin+Sulfonylurea) | Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment | -1.5 cm | Standard Error 0.3 |
| Placebo (Metformin+Sulfonylurea) | Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment | -0.2 cm | Standard Error 0.3 |
p-value: 0.000195% CI: [-3.1, -1]ANCOVA
p-value: 0.001595% CI: [-2.8, -0.7]ANCOVA
p-value: 0.505295% CI: [-0.7, 1.4]ANCOVA
p-value: <0.000195% CI: [-3.5, -1.4]ANCOVA
p-value: 0.000195% CI: [-3.1, -1]ANCOVA
p-value: 0.006495% CI: [-2.6, -0.4]ANCOVA
p-value: 0.064295% CI: [-2.1, 0.1]ANCOVA
p-value: 0.005395% CI: [-1.8, -0.3]ANCOVA
p-value: <0.000195% CI: [-2.3, -0.9]ANCOVA
p-value: 0.00195% CI: [-2.1, -0.6]ANCOVA
p-value: 0.001595% CI: [-2.1, -0.5]ANCOVA
Secondary
Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment
Waist circumference (cm) - change from baseline after 76 weeks of treatment
Time frame: Baseline and 76 weeks
Population: Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline waist circumference assessment, irrespective of participation in the extension trial -LOCF
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BI 10773 Low (Drug Naive) | Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment | -1.5 cm | Standard Error 0.4 |
| BI 10773 High (Drug Naive) | Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment | -1.6 cm | Standard Error 0.4 |
| Placebo (Drug Naive) | Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment | 0.1 cm | Standard Error 0.4 |
| Sitagliptin 100mg (Drug Naive) | Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment | 0.5 cm | Standard Error 0.4 |
| BI 10773 Low (Pioglitazone) | Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment | -1.4 cm | Standard Error 0.4 |
| BI 10773 High (Pioglitazone) | Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment | -0.9 cm | Standard Error 0.4 |
| Placebo (Pioglitazone) | Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment | 0.0 cm | Standard Error 0.4 |
| BI 10773 Low (Metformin) | Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment | -1.8 cm | Standard Error 0.3 |
| BI 10773 High (Metformin) | Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment | -1.3 cm | Standard Error 0.3 |
| Placebo (Metformin) | Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment | -0.2 cm | Standard Error 0.3 |
| BI 10773 Low (Metformin+Sulfonylurea) | Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment | -1.6 cm | Standard Error 0.3 |
| BI 10773 High (Metformin+Sulfonylurea) | Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment | -1.4 cm | Standard Error 0.3 |
| Placebo (Metformin+Sulfonylurea) | Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment | -0.3 cm | Standard Error 0.3 |
p-value: 0.002895% CI: [-2.7, -0.6]ANCOVA
p-value: 0.001995% CI: [-2.8, -0.6]ANCOVA
p-value: 0.504495% CI: [-0.7, 1.5]ANCOVA
p-value: 0.000395% CI: [-3.1, -0.9]ANCOVA
p-value: 0.000295% CI: [-3.2, -1]ANCOVA
p-value: 0.010995% CI: [-2.5, -0.3]ANCOVA
p-value: 0.123895% CI: [-1.9, 0.2]ANCOVA
p-value: <0.000195% CI: [-2.4, -0.8]ANCOVA
p-value: 0.007695% CI: [-1.9, -0.3]ANCOVA
p-value: 0.004995% CI: [-2.1, -0.4]ANCOVA
p-value: 0.017895% CI: [-1.9, -0.2]ANCOVA