| Primary | Hemoglobin A1c (A1C) Changes From Baseline at Week 24 | To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%. | Randomized participants with both a baseline and post-baseline value (up to Week 24). | Posted | | Mean | Standard Error | Percentage of glycosylated hemoglobins | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saxagliptin 2.5 mg | Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG001 | Saxagliptin 5 mg | Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG002 | Saxagliptin 10 mg | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG003 | Placebo | Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue) |
| | Units | Counts |
|---|
| Participants | - OG000102
- OG001106
- OG00298
- OG003
|
| | Title | Denominators | Categories |
|---|
| Baseline Mean | | | Title | Measurements |
|---|
| - OG0007.91± 0.09
- OG0017.98± 0.11
- OG0027.85± 0.09
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline. | <.0001 | Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing. | Mean Difference (Final Values) | -0.62 | Standard Error of the Mean | 0.14 | 2-Sided | 95 | -0.90 | -0.33 | | | ANCOVA model:post - pre = pre treatment | No | Superiority or Other | |
|
| Secondary | Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) | | Randomized participants with measure at given time points, Last Observation Carried Forward (LOCF). | Posted | | Mean | Standard Error | mg/dL | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saxagliptin 2.5 mg | Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG001 | Saxagliptin 5 mg | Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG002 | Saxagliptin 10 mg | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG003 | Placebo | Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue) |
| |
| Secondary | Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 | | Randomized Participants with measurement at time point, Last Observation Carried Forward (LOCF) | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saxagliptin 2.5 mg | Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG001 | Saxagliptin 5 mg | Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG002 | Saxagliptin 10 mg | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG003 | Placebo | Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue) |
| |
| Secondary | Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) | | Randomized participants with measure at given time points, Last Observation Carried Forward (LOCF). | Posted | | Mean | Standard Error | mg*min/dL | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saxagliptin 2.5 mg | Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG001 | Saxagliptin 5 mg | Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG002 | Saxagliptin 10 mg | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG003 | Placebo | Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue) |
| |
| Secondary | Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) - Open Label Cohort | | Open Label Subjects with Measurement at Timepoint; Last Observation Carried Forward (LOCF) | Posted | | Mean | Standard Error | mg/dL | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Open-Label Cohort (Direct Enrollees) | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). |
| | |
| Secondary | Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 - Open Label Cohort | | Open Label Participants with measurement at time point, Last Observation Carried Forward (LOCF) | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Open Label Cohort (Direct Enrollees) | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). |
| | |
| Primary | A1C Changes From Baseline at Week 24 - Open Label Cohort | To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%. | Open-label participants with both a baseline and a post-baseline (up to Week 24) | Posted | | Mean | Standard Error | Percentage of glycosylated hemoglobins | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Open Label Cohort (Direct Enrollees) | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). |
| |
| Secondary | Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) - Open Label Cohort | | Open Label participants with measure at given time points, Last Observation Carried Forward (LOCF). | Posted | | Mean | Standard Error | mg*min/dL | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Open Label Cohort (Direct Enrollees) | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). |
| | |
| Other Pre-specified | Baseline Demographic Characteristic (Age, Continuous) - Summary for ST + LT Treatment Period - Open-Label Cohort | This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report. | | Posted | | Mean | Standard Deviation | years | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Open-Label Treatment Cohort (Direct Enrollees) | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). |
| | |
| Other Pre-specified | Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort | This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report. | | Posted | | Number | | participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Open-Label Treatment Cohort (Direct Enrollees) | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). |
| | |
| Other Pre-specified | Baseline Demographic Characteristic (Weight) - Summary for ST + LT Treatment Period - Open-Label Cohort | This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report. | | Posted | | Mean | Standard Deviation | kg | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Open-Label Treatment Cohort (Direct Enrollees) | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). |
| | |
| Other Pre-specified | Baseline Demographic Characteristic (Body Mass Index) - Summary for ST + LT Treatment Period - Open-Label Cohort | This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report. | | Posted | | Mean | Standard Deviation | kg/m^2 | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Open-Label Treatment Cohort (Direct Enrollees) | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). |
| | |
| Other Pre-specified | Overall Summary of Adverse Events During ST+LT Treatment Period | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing. | | Posted | | Number | | participants | | AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm. | | | | ID | Title | Description |
|---|
| OG000 | Saxagliptin 2.5 mg | Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG001 | Saxagliptin 5 mg | Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG002 | Saxagliptin 10 mg |
|
| Other Pre-specified | Marked Laboratory Abnormalities - During ST + LT Treatment Period | A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal. | Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period | Posted | | Number | | participants | | Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm. | | | | ID | Title | Description |
|---|
| OG000 | Saxagliptin 2.5 mg | Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG001 | Saxagliptin 5 mg | Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | |
|
| Other Pre-specified | Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period | | Treated participants; n=number of treated participants with measurement at time point | Posted | | Mean | Standard Error | g/dL | | Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 | | | | ID | Title | Description |
|---|
| OG000 | Saxagliptin 2.5 mg | Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG001 | Saxagliptin 5 mg | Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG002 | Saxagliptin 10 mg | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG003 | Placebo | Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue) |
| |
| Other Pre-specified | Baseline and Changes From Baseline in Hematocrit During the ST + LT Period | | Treated participants; n=number of treated participants with measurement at time point | Posted | | Mean | Standard Error | percentage red blood cells | | Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 | | | | ID | Title | Description |
|---|
| OG000 | Saxagliptin 2.5 mg | Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG001 | Saxagliptin 5 mg | Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG002 | Saxagliptin 10 mg | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG003 | Placebo | Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue) |
| |
| Other Pre-specified | Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period | | Treated participants; n=number of treated participants with measurement at time point | Posted | | Mean | Standard Error | x 10^6 c/µL | | Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 | | | | ID | Title | Description |
|---|
| OG000 | Saxagliptin 2.5 mg | Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG001 | Saxagliptin 5 mg | Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG002 | Saxagliptin 10 mg | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG003 | Placebo | Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue) |
| |
| Other Pre-specified | Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period | | Treated participants; n=number of treated participants with measurement at time point | Posted | | Mean | Standard Error | x 10^9 c/L | | Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 | | | | ID | Title | Description |
|---|
| OG000 | Saxagliptin 2.5 mg | Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG001 | Saxagliptin 5 mg | Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG002 | Saxagliptin 10 mg | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG003 | Placebo | Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue) |
| |
| Other Pre-specified | Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period | | Treated participants; n=number of treated participants with measurement at time point | Posted | | Mean | Standard Error | x 10^3 c/µL | | Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 | | | | ID | Title | Description |
|---|
| OG000 | Saxagliptin 2.5 mg | Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG001 | Saxagliptin 5 mg | Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG002 | Saxagliptin 10 mg | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG003 | Placebo | Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue) |
| |
| Other Pre-specified | Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period | | Treated participants; n=number of treated participants with measurement at time point | Posted | | Mean | Standard Error | x 10^3 c/µL | | Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 | | | | ID | Title | Description |
|---|
| OG000 | Saxagliptin 2.5 mg | Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG001 | Saxagliptin 5 mg | Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG002 | Saxagliptin 10 mg | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG003 | Placebo | Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue) |
| |
| Other Pre-specified | Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period | | Treated participants; n=number of treated participants with measurement at time point | Posted | | Mean | Standard Error | x 10^3 c/µL | | Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 | | | | ID | Title | Description |
|---|
| OG000 | Saxagliptin 2.5 mg | Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG001 | Saxagliptin 5 mg | Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG002 | Saxagliptin 10 mg | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG003 | Placebo | Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue) |
| |
| Other Pre-specified | Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period | | Treated participants; n=number of treated participants with measurement at time point | Posted | | Mean | Standard Error | x 10^3 c/µL | | Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 | | | | ID | Title | Description |
|---|
| OG000 | Saxagliptin 2.5 mg | Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG001 | Saxagliptin 5 mg | Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG002 | Saxagliptin 10 mg | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG003 | Placebo | Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue) |
| |
| Other Pre-specified | Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period | | Treated participants; n=number of treated participants with measurement at time point | Posted | | Mean | Standard Error | x 10^3 c/µL | | Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 | | | | ID | Title | Description |
|---|
| OG000 | Saxagliptin 2.5 mg | Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG001 | Saxagliptin 5 mg | Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG002 | Saxagliptin 10 mg | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG003 | Placebo | Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue) |
| |
| Other Pre-specified | Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period | | Treated participants; n=number of treated participants with measurement at time point | Posted | | Mean | Standard Error | x 10^3 c/µL | | Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 | | | | ID | Title | Description |
|---|
| OG000 | Saxagliptin 2.5 mg | Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG001 | Saxagliptin 5 mg | Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG002 | Saxagliptin 10 mg | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG003 | Placebo | Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue) |
| |
| Other Pre-specified | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period | | Treated participants; n=number of treated participants with measurement at time point | Posted | | Mean | Standard Error | mmHg | | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 | | | | ID | Title | Description |
|---|
| OG000 | Saxagliptin 2.5 mg | Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG001 | Saxagliptin 5 mg | Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG002 | Saxagliptin 10 mg | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG003 | Placebo | Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue) |
| |
| Other Pre-specified | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period | | Treated participants; n=number of treated participants with measurement at time point | Posted | | Mean | Standard Error | mmHg | | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 | | | | ID | Title | Description |
|---|
| OG000 | Saxagliptin 2.5 mg | Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG001 | Saxagliptin 5 mg | Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG002 | Saxagliptin 10 mg | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG003 | Placebo | Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue) |
| |
| Other Pre-specified | Changes From Baseline in Heart Rate During the ST + LT Period | | Treated participants; n=number of treated participants with measurement at time point | Posted | | Mean | Standard Error | beats per minute | | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 | | | | ID | Title | Description |
|---|
| OG000 | Saxagliptin 2.5 mg | Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG001 | Saxagliptin 5 mg | Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG002 | Saxagliptin 10 mg | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG003 | Placebo | Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue) |
| |
| Other Pre-specified | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period | The normality/abnormality of the ECG tracing was determined by the investigator. | Treated participants; BL n=number of participants at baseline | Posted | | Number | | participants | | Baseline, Weeks 12, 24, 76, 102, 154, 206 | | | | ID | Title | Description |
|---|
| OG000 | Saxagliptin 2.5 mg | Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG001 | Saxagliptin 5 mg | Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG002 | Saxagliptin 10 mg | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG003 | Placebo | Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue) |
|
| Other Pre-specified | Overall Summary of Adverse Events During ST+LT Treatment Period - Open-Label Cohort | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing. | | Posted | | Number | | participants | | AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks. | | | | ID | Title | Description |
|---|
| OG000 | Open-Label Treatment Cohort (Direct Enrollees) | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). |
| |
| Other Pre-specified | Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort | A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal. | Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period | Posted | | Number | | participants | | Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure was 34 weeks. | | | | ID | Title | Description |
|---|
| OG000 | Open-Label Treatment Cohort (Direct Enrollees) | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). |
| |
| Other Pre-specified | All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period | Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness. | | Posted | | Number | | participants | | AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm. | | | | ID | Title | Description |
|---|
| OG000 | Saxagliptin 2.5 mg | Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG001 | Saxagliptin 5 mg | Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG002 | Saxagliptin 10 mg | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG003 | Placebo | |
|
| Other Pre-specified | Confirmed Hypoglycemia During ST + LT Treatment Period | 'Confirmed' = recorded on the hypoglycemia AE case report form page with a fingerstick glucose <= 50 mg/dL and associated symptoms | | Posted | | Number | | participants | | AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm. | | | | ID | Title | Description |
|---|
| OG000 | Saxagliptin 2.5 mg | Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG001 | Saxagliptin 5 mg | Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG002 | Saxagliptin 10 mg | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). | | OG003 | Placebo | |
|
| Other Pre-specified | All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period - Open-Label Cohort | Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness. | | Posted | | Number | | participants | | AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks. | | | | ID | Title | Description |
|---|
| OG000 | Open-Label Treatment Cohort (Direct Enrollees) | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). |
| |
| Other Pre-specified | Confirmed Hypoglycemia During ST + LT Treatment Period - Open-Label Cohort | 'Confirmed' = recorded on the hypoglycemia AE case report form page with a fingerstick glucose <= 50 mg/dL and associated symptoms | | Posted | | Number | | participants | | AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks. | | | | ID | Title | Description |
|---|
| OG000 | Open-Label Treatment Cohort (Direct Enrollees) | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). |
| |
| Other Pre-specified | Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort | The normality/abnormality of the ECG tracing was determined by the investigator. | Treated participants; BL n=number of participants at baseline | Posted | | Number | | participants | | Baseline, Weeks 12, 24, 76, 102, 154, 206 | | | | ID | Title | Description |
|---|
| OG000 | Open-Label Treatment Cohort (Direct Enrollees) | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). |
| |
| Other Pre-specified | Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort | | Treated participants; n=number of treated participants with measurement at time point | Posted | | Mean | Standard Error | mmHg | | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167 | | | | ID | Title | Description |
|---|
| OG000 | Open-Label Treatment Cohort (Direct Enrollees) | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). |
| | |
| Other Pre-specified | Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort | | Treated participants; n=number of treated participants with measurement at time point | Posted | | Mean | Standard Error | mmHg | | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167 | | | | ID | Title | Description |
|---|
| OG000 | Open-Label Treatment Cohort (Direct Enrollees) | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). |
| | |
| Other Pre-specified | Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort | | Treated participants; n=number of treated participants with measurement at time point | Posted | | Mean | Standard Error | beats per minute | | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167 | | | | ID | Title | Description |
|---|
| OG000 | Open-Label Treatment Cohort (Direct Enrollees) | Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). |
| | |