Trial Outcomes & Findings for Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin (NCT NCT00757588)
NCT ID: NCT00757588
Last Updated: 2015-06-01
Results Overview
Change from baseline: post-pre. Adjusted for baseline (value and metformin use). ANCOVA model: difference between week t and baseline values=baseline values + treatment + metformin use
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
455 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2015-06-01
Participant Flow
Of 455 participants randomized, 402 received treatment and completed the 24-week phase. Two participants were mistakenly identified as not completing the short-term (ST) treatment period, although they did. The discrepancy was identified after the ST phase database lock. In reality, 404 completed the ST phase.
Participant milestones
| Measure |
Saxagliptin, 5 mg + Insulin
Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
Placebo + Insulin
Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
|---|---|---|
|
Period 1: Short-term (24-week) Phase
STARTED
|
304
|
151
|
|
Period 1: Short-term (24-week) Phase
COMPLETED
|
268
|
134
|
|
Period 1: Short-term (24-week) Phase
NOT COMPLETED
|
36
|
17
|
|
Period 2: Long-term (52-week) Phase
STARTED
|
268
|
134
|
|
Period 2: Long-term (52-week) Phase
COMPLETED
|
246
|
125
|
|
Period 2: Long-term (52-week) Phase
NOT COMPLETED
|
22
|
9
|
Reasons for withdrawal
| Measure |
Saxagliptin, 5 mg + Insulin
Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
Placebo + Insulin
Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
|---|---|---|
|
Period 1: Short-term (24-week) Phase
Lack of Efficacy
|
3
|
2
|
|
Period 1: Short-term (24-week) Phase
Adverse Event
|
6
|
3
|
|
Period 1: Short-term (24-week) Phase
Withdrawal by Subject
|
13
|
5
|
|
Period 1: Short-term (24-week) Phase
Death
|
1
|
0
|
|
Period 1: Short-term (24-week) Phase
Lost to Follow-up
|
3
|
5
|
|
Period 1: Short-term (24-week) Phase
Poor compliance or noncompliance
|
5
|
1
|
|
Period 1: Short-term (24-week) Phase
No longer meets study criteria
|
5
|
0
|
|
Period 1: Short-term (24-week) Phase
Other
|
0
|
1
|
|
Period 2: Long-term (52-week) Phase
Lack of Efficacy
|
1
|
0
|
|
Period 2: Long-term (52-week) Phase
Adverse Event
|
4
|
0
|
|
Period 2: Long-term (52-week) Phase
Withdrawal by Subject
|
4
|
2
|
|
Period 2: Long-term (52-week) Phase
Lost to Follow-up
|
1
|
1
|
|
Period 2: Long-term (52-week) Phase
Poor or noncompliance
|
5
|
2
|
|
Period 2: Long-term (52-week) Phase
Pregnancy
|
1
|
0
|
|
Period 2: Long-term (52-week) Phase
No longer meets study criteria
|
5
|
4
|
|
Period 2: Long-term (52-week) Phase
Other
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin
Baseline characteristics by cohort
| Measure |
Saxagliptin, 5 mg + Insulin
n=304 Participants
Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
Placebo + Insulin
n=151 Participants
Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
Total
n=455 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
57.2 Years
STANDARD_DEVIATION 9.43 • n=5 Participants
|
57.3 Years
STANDARD_DEVIATION 9.27 • n=7 Participants
|
57.2 Years
STANDARD_DEVIATION 9.37 • n=5 Participants
|
|
Age, Customized
Younger than 65 years
|
233 participants
n=5 Participants
|
118 participants
n=7 Participants
|
351 participants
n=5 Participants
|
|
Age, Customized
65 years to younger than 75 years
|
65 participants
n=5 Participants
|
30 participants
n=7 Participants
|
95 participants
n=5 Participants
|
|
Age, Customized
75 years and older
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
184 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
267 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
40 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
237 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
355 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Randomized participants who received at least 1 dose of double-blind study medication. Participants must also have had both a baseline and at least 1 postrandomization measurement in the 24- and 52-week periods.
Change from baseline: post-pre. Adjusted for baseline (value and metformin use). ANCOVA model: difference between week t and baseline values=baseline values + treatment + metformin use
Outcome measures
| Measure |
Saxagliptin, 5 mg + Insulin
n=300 Participants
Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
Placebo + Insulin
n=149 Participants
Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
|---|---|---|
|
Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF])
|
-0.73 Percentage of change
Standard Error 0.054
|
-0.32 Percentage of change
Standard Error 0.074
|
SECONDARY outcome
Timeframe: Baseline to Week 24An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal
Outcome measures
| Measure |
Saxagliptin, 5 mg + Insulin
n=258 Participants
Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
Placebo + Insulin
n=122 Participants
Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
|---|---|---|
|
Change From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Meal Tolerance Test (MTT)
|
-4548.5 mg*min/dL
Standard Error 687.65
|
-718.8 mg*min/dL
Standard Error 981.63
|
SECONDARY outcome
Timeframe: Baseline to Week 24An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal.
Outcome measures
| Measure |
Saxagliptin, 5 mg + Insulin
n=262 Participants
Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
Placebo + Insulin
n=129 Participants
Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
|---|---|---|
|
Change From Baseline in 120-minute PPG Values During an MTT
|
-27.2 mg/dL
Standard Error 4.35
|
-4.2 mg/dL
Standard Error 6.08
|
SECONDARY outcome
Timeframe: Baseline to Week 24Outcome measures
| Measure |
Saxagliptin, 5 mg + Insulin
n=300 Participants
Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
Placebo + Insulin
n=149 Participants
Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose Values
|
-10.1 mg/dL
Standard Error 2.87
|
-6.1 mg/dL
Standard Error 3.98
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Randomized participants who received at least 1 dose of double-blind study medication. Participants must also have had both a baseline and at least 1 postrandomization measurement in the 24-week period.
Therapeutic glycemic response is defined as an A1C\<7%. Significance was not interpreted with a p value.
Outcome measures
| Measure |
Saxagliptin, 5 mg + Insulin
n=300 Participants
Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
Placebo + Insulin
n=149 Participants
Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
|---|---|---|
|
Percentage of Participants Achieving a Therapeutic Glycemic Response
|
17.3 Percentage of participants
|
6.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Randomized participants who received at least 1 dose of double-blind study medication. Participants must also have had both a baseline and at least 1 postrandomization measurement in the 24-week period.
Based on information recorded in the participant's daily diary. The MTDDI was calculated at every visit using the values patients recorded since the last regularly scheduled visit (minimum of 80% of days with a value). At every visit, the MTDDI was compared with the participant's baseline MTDDI (measured during a 4-week lead-in period) to identify any changes in insulin use at that visit compared with insulin use at baseline.
Outcome measures
| Measure |
Saxagliptin, 5 mg + Insulin
n=299 Participants
Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
Placebo + Insulin
n=151 Participants
Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
|---|---|---|
|
Change From Baseline in Mean Total Daily Dose of Insulin (MTDDI) (LOCF)
|
1.71 Units
Standard Error 0.704
|
5.01 Units
Standard Error 0.970
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52Population: Participants who had normal ECG findings at baseline and who received at least 1 dose of study medication.
ECG abnormalities included those in nonspecific "other" categories (Other nonspecific ST/T, Other intraventricular conduction defect, Other, and Other rhythm abnormalities)and nonspecific findings, such as sinus bradycardia, sinus arrythmia, sinus tachycardia, poor R-wave progression, and ventricular premature contractions.
Outcome measures
| Measure |
Saxagliptin, 5 mg + Insulin
n=153 Participants
Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
Placebo + Insulin
n=75 Participants
Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
|---|---|---|
|
Number of Participants With Abnormal Changes From Baseline in Electrocardiogram (ECG) Results
|
15 Participants
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Weeks 24 and 52Population: All participants who received at least 1 dose of double-blind study medication.
Absolute lymphocyte count=value\*10\^3 c/uL
Outcome measures
| Measure |
Saxagliptin, 5 mg + Insulin
n=304 Participants
Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
Placebo + Insulin
n=151 Participants
Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
|---|---|---|
|
Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)
Baseline >0.75- <= 5.00; Week 52 >5.00
|
0 Participants
|
1 Participants
|
|
Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)
Baseline <= 0.75; Week 24 <= 0.75
|
0 Participants
|
0 Participants
|
|
Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)
Baseline <= 0.75; Week 24 >0.75- <= 5.00
|
0 Participants
|
2 Participants
|
|
Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)
Baseline <= 0.75; Week 24 >5.00
|
0 Participants
|
0 Participants
|
|
Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)
Baseline >0.75- <= 5.00; Week 24 <= 0.75
|
1 Participants
|
0 Participants
|
|
Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)
Baseline >0.75- <= 5.00; Week 24 >0.75- <= 5.00
|
293 Participants
|
148 Participants
|
|
Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)
Baseline >0.75- <= 5.00; Week 24 >5.00
|
1 Participants
|
0 Participants
|
|
Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)
Baseline >5.00; Week 24 <= 0.75
|
0 Participants
|
0 Participants
|
|
Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)
Baseline >5.00; Week 24 >0.75- <= 5.00
|
0 Participants
|
0 Participants
|
|
Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)
Baseline >5.00; Week 24 >5.00
|
1 Participants
|
0 Participants
|
|
Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)
Baseline <= 0.75; Week 52 <= 0.75
|
0 Participants
|
0 Participants
|
|
Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)
Baseline <= 0.75; Week 52 >0.75- <= 5.00
|
0 Participants
|
2 Participants
|
|
Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)
Baseline <= 0.75; Week 52 >5.00
|
0 Participants
|
0 Participants
|
|
Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)
Baseline >0.75- <= 5.00; Week 52 <= 0.75
|
0 Participants
|
0 Participants
|
|
Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)
Baseline >0.75- <= 5.00; Week 52 >0.75- <= 5.00
|
295 Participants
|
147 Participants
|
|
Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)
Baseline >5.00; Week 52 <= 0.75
|
0 Participants
|
0 Participants
|
|
Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)
Baseline >5.00; Week 52 >0.75- <= 5.00
|
0 Participants
|
0 Participants
|
|
Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)
Baseline >5.00; Week 52 >5.00
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52, continuouslyPopulation: All participants who received at least 1 dose of double-blind study medication.
An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.
Outcome measures
| Measure |
Saxagliptin, 5 mg + Insulin
n=304 Participants
Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
Placebo + Insulin
n=151 Participants
Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
|---|---|---|
|
Number of Participants With at Least 1 Adverse Event (AE), at Least 1 Treatment-related AE, Death as Outcome, at Least 1 Serious Adverse Event (SAE), at Least 1 Treatment-related SAE, Discontinuations Due to SAEs, and Discontinuations Due to AEs
Discontinuations due to SAEs
|
4 Participants
|
0 Participants
|
|
Number of Participants With at Least 1 Adverse Event (AE), at Least 1 Treatment-related AE, Death as Outcome, at Least 1 Serious Adverse Event (SAE), at Least 1 Treatment-related SAE, Discontinuations Due to SAEs, and Discontinuations Due to AEs
Discontinuations due to AEs
|
9 Participants
|
3 Participants
|
|
Number of Participants With at Least 1 Adverse Event (AE), at Least 1 Treatment-related AE, Death as Outcome, at Least 1 Serious Adverse Event (SAE), at Least 1 Treatment-related SAE, Discontinuations Due to SAEs, and Discontinuations Due to AEs
At least 1 AE
|
202 Participants
|
108 Participants
|
|
Number of Participants With at Least 1 Adverse Event (AE), at Least 1 Treatment-related AE, Death as Outcome, at Least 1 Serious Adverse Event (SAE), at Least 1 Treatment-related SAE, Discontinuations Due to SAEs, and Discontinuations Due to AEs
At least 1 treatment-related AE
|
56 Participants
|
34 Participants
|
|
Number of Participants With at Least 1 Adverse Event (AE), at Least 1 Treatment-related AE, Death as Outcome, at Least 1 Serious Adverse Event (SAE), at Least 1 Treatment-related SAE, Discontinuations Due to SAEs, and Discontinuations Due to AEs
Deaths
|
2 Participants
|
0 Participants
|
|
Number of Participants With at Least 1 Adverse Event (AE), at Least 1 Treatment-related AE, Death as Outcome, at Least 1 Serious Adverse Event (SAE), at Least 1 Treatment-related SAE, Discontinuations Due to SAEs, and Discontinuations Due to AEs
At least 1 SAE
|
25 Participants
|
13 Participants
|
|
Number of Participants With at Least 1 Adverse Event (AE), at Least 1 Treatment-related AE, Death as Outcome, at Least 1 Serious Adverse Event (SAE), at Least 1 Treatment-related SAE, Discontinuations Due to SAEs, and Discontinuations Due to AEs
At least 1 treatment-related SAE
|
3 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52Population: All participants who received at least 1 dose of double-blind study medication.
Outcome measures
| Measure |
Saxagliptin, 5 mg + Insulin
n=304 Participants
Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
Placebo + Insulin
n=151 Participants
Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
|---|---|---|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Diastolic blood pressure (Week 44) (n=250, 125)
|
-0.3 mm Hg
Interval -1.5 to 1.0
|
0.4 mm Hg
Interval -1.0 to 1.8
|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Diastolic blood pressure (Week 52) (n=246, 125)
|
-0.5 mm Hg
Interval -1.7 to 0.7
|
0.1 mm Hg
Interval -1.4 to 1.6
|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Systolic blood pressure (Week 2) (n=294, 147)
|
-1.0 mm Hg
Interval -2.3 to 0.4
|
2.3 mm Hg
Interval 0.0 to 4.6
|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Systolic blood pressure (Week 4) (n=293, 144)
|
-1.2 mm Hg
Interval -2.6 to 0.2
|
0.0 mm Hg
Interval -2.3 to 2.4
|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Systolic blood pressure (Week 6) (n=280, 141)
|
-0.8 mm Hg
Interval -2.4 to 0.7
|
1.0 mm Hg
Interval -1.2 to 3.2
|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Systolic blood pressure (Week 8) (n=290, 142)
|
-0.8 mm Hg
Interval -2.4 to 0.8
|
2.4 mm Hg
Interval -0.2 to 4.9
|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Systolic blood pressure (Week 12) (n=286, 144)
|
-1.7 mm Hg
Interval -3.2 to -0.2
|
2.2 mm Hg
Interval 0.0 to 4.3
|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Systolic blood pressure (Week 16) (n=278, 139)
|
-1.2 mm Hg
Interval -2.9 to 0.5
|
1.1 mm Hg
Interval -1.1 to 3.3
|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Systolic blood pressure (Week 20) (n=276, 137)
|
-0.6 mm Hg
Interval -2.0 to 0.9
|
1.3 mm Hg
Interval -1.0 to 3.7
|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Systolic blood pressure (Week 24) (n=273, 134)
|
-1.5 mm Hg
Interval -3.2 to 0.1
|
-0.1 mm Hg
Interval -2.2 to 2.0
|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Systolic blood pressure (Week 28) (n=264, 132)
|
-1.4 mm Hg
Interval -3.0 to 0.1
|
1.8 mm Hg
Interval -0.6 to 4.2
|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Systolic blood pressure (Week 36) (n=261, 129)
|
-0.7 mm Hg
Interval -2.4 to 1.1
|
3.6 mm Hg
Interval 1.2 to 6.0
|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Systolic blood pressure (Week 44) (n=250, 125)
|
-0.6 mm Hg
Interval -2.2 to 1.0
|
2.6 mm Hg
Interval 0.4 to 4.8
|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Systolic blood pressure (Week 52) (n=246, 125)
|
0.0 mm Hg
Interval -1.7 to 1.7
|
1.0 mm Hg
Interval -1.3 to 3.3
|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Diastolic blood pressure (Week 2) (n=294, 147)
|
0.1 mm Hg
Interval -0.9 to 1.0
|
1.4 mm Hg
Interval 0.0 to 2.8
|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Diastolic blood pressure (Week 4) (n=293, 144)
|
0.0 mm Hg
Interval -1.0 to 1.1
|
1.8 mm Hg
Interval 0.4 to 3.2
|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Diastolic blood pressure (Week 6) (n=280, 141)
|
0.0 mm Hg
Interval -1.0 to 1.1
|
0.3 mm Hg
Interval -1.1 to 1.8
|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Diastolic blood pressure (Week 8) (n=290, 142)
|
-0.5 mm Hg
Interval -1.5 to 0.4
|
2.1 mm Hg
Interval 0.6 to 3.6
|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Diastolic blood pressure (Week 12) (n=286, 144)
|
-0.8 mm Hg
Interval -1.8 to 0.2
|
1.0 mm Hg
Interval -0.3 to 2.4
|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Diastolic blood pressure (Week 16) (n=278, 139)
|
-1.1 mm Hg
Interval -2.1 to -0.1
|
1.3 mm Hg
Interval 0.0 to 2.6
|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Diastolic blood pressure (Week 20) (n=276, 137)
|
-0.7 mm Hg
Interval -1.8 to 0.4
|
1.1 mm Hg
Interval -0.3 to 2.5
|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Diastolic blood pressure (Week 24) (n=273, 134)
|
-1.7 mm Hg
Interval -2.8 to -0.6
|
0.5 mm Hg
Interval -0.9 to 1.9
|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Diastolic blood pressure (Week 28) (n=264, 132)
|
-1.6 mm Hg
Interval -2.7 to -0.5
|
0.2 mm Hg
Interval -1.3 to 1.7
|
|
Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings
Diastolic blood pressure (Week 36) (n=261, 129)
|
-1.2 mm Hg
Interval -2.4 to 0.1
|
0.2 mm Hg
Interval -1.1 to 1.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52Population: All participants who received at least 1 dose of double-blind study medication.
Outcome measures
| Measure |
Saxagliptin, 5 mg + Insulin
n=304 Participants
Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
Placebo + Insulin
n=151 Participants
Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
|---|---|---|
|
Mean Changes From Baseline in Heart Rate
Week 2 (n=294, 147)
|
-0.5 Beats per minute
Interval -1.4 to 0.4
|
-0.7 Beats per minute
Interval -1.8 to 0.4
|
|
Mean Changes From Baseline in Heart Rate
Week 4 (n=293, 144)
|
-0.5 Beats per minute
Interval -1.5 to 0.5
|
-1.0 Beats per minute
Interval -2.1 to 0.2
|
|
Mean Changes From Baseline in Heart Rate
Week 6 (n=280, 141)
|
-0.5 Beats per minute
Interval -1.5 to 0.4
|
-0.9 Beats per minute
Interval -2.3 to 0.4
|
|
Mean Changes From Baseline in Heart Rate
Week 8 (n=290, 142)
|
-0.0 Beats per minute
Interval -1.0 to 1.0
|
-0.7 Beats per minute
Interval -2.0 to 0.6
|
|
Mean Changes From Baseline in Heart Rate
Week 12 (n=286, 144)
|
0.3 Beats per minute
Interval -0.7 to 1.3
|
0.2 Beats per minute
Interval -1.0 to 1.4
|
|
Mean Changes From Baseline in Heart Rate
Week 16 (n=278, 139)
|
-1.0 Beats per minute
Interval -2.1 to 0.1
|
-0.6 Beats per minute
Interval -2.1 to 1.0
|
|
Mean Changes From Baseline in Heart Rate
Week 20 (n=276, 137)
|
-0.5 Beats per minute
Interval -1.6 to 0.6
|
0.4 Beats per minute
Interval -0.9 to 1.8
|
|
Mean Changes From Baseline in Heart Rate
Week 24 (n=273, 134)
|
0.0 Beats per minute
Interval -1.2 to 1.3
|
-1.0 Beats per minute
Interval -2.5 to 0.4
|
|
Mean Changes From Baseline in Heart Rate
Week 28 (n=264, 132)
|
-1.0 Beats per minute
Interval -2.1 to 0.2
|
-0.6 Beats per minute
Interval -2.1 to 0.9
|
|
Mean Changes From Baseline in Heart Rate
Week 36 (n=261, 129)
|
0.0 Beats per minute
Interval -1.1 to 1.2
|
-0.0 Beats per minute
Interval -1.4 to 1.4
|
|
Mean Changes From Baseline in Heart Rate
Week 44 (n=250, 125)
|
0.2 Beats per minute
Interval -0.9 to 1.4
|
-0.7 Beats per minute
Interval -2.3 to 1.0
|
|
Mean Changes From Baseline in Heart Rate
Week 52 (n=246, 125)
|
-0.3 Beats per minute
Interval -1.5 to 0.8
|
0.2 Beats per minute
Interval -1.7 to 2.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Weeks 24 and 52Population: All participants who received at least 1 dose of double-blind study medication.
Platelet count=value\*10\^9 c/L
Outcome measures
| Measure |
Saxagliptin, 5 mg + Insulin
n=304 Participants
Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
Placebo + Insulin
n=151 Participants
Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
|---|---|---|
|
Shift in Platelet Counts From Baseline to Selected Visits (LOCF)
Baseline >100 - <= 600; Week 24 >600
|
0 Participants
|
0 Participants
|
|
Shift in Platelet Counts From Baseline to Selected Visits (LOCF)
Baseline >600; Week 24 <= 100
|
0 Participants
|
0 Participants
|
|
Shift in Platelet Counts From Baseline to Selected Visits (LOCF)
Baseline <= 100; Week 24 <= 100
|
0 Participants
|
0 Participants
|
|
Shift in Platelet Counts From Baseline to Selected Visits (LOCF)
Baseline <= 100; Week 24 >100 - <= 600
|
0 Participants
|
0 Participants
|
|
Shift in Platelet Counts From Baseline to Selected Visits (LOCF)
Baseline <= 100; Week 24 >600
|
0 Participants
|
0 Participants
|
|
Shift in Platelet Counts From Baseline to Selected Visits (LOCF)
Baseline >100 - <= 600; Week 24 <= 100
|
1 Participants
|
1 Participants
|
|
Shift in Platelet Counts From Baseline to Selected Visits (LOCF)
Baseline >100 - <= 600; Week 24 >100 - <= 600
|
296 Participants
|
143 Participants
|
|
Shift in Platelet Counts From Baseline to Selected Visits (LOCF)
Baseline >600; Week 24 >100 - <= 600
|
0 Participants
|
0 Participants
|
|
Shift in Platelet Counts From Baseline to Selected Visits (LOCF)
Baseline >600; Week 24 >600
|
0 Participants
|
0 Participants
|
|
Shift in Platelet Counts From Baseline to Selected Visits (LOCF)
Baseline <= 100; Week 52 <= 100
|
0 Participants
|
0 Participants
|
|
Shift in Platelet Counts From Baseline to Selected Visits (LOCF)
Baseline <= 100; Week 52 >100 - <= 600
|
0 Participants
|
1 Participants
|
|
Shift in Platelet Counts From Baseline to Selected Visits (LOCF)
Baseline <= 100; Week 52 >600
|
0 Participants
|
0 Participants
|
|
Shift in Platelet Counts From Baseline to Selected Visits (LOCF)
Baseline >100 - <= 600; Week 52 <= 100
|
2 Participants
|
0 Participants
|
|
Shift in Platelet Counts From Baseline to Selected Visits (LOCF)
Baseline >100 - <= 600; Week 52 >100 - <= 600
|
295 Participants
|
144 Participants
|
|
Shift in Platelet Counts From Baseline to Selected Visits (LOCF)
Baseline >100 - <= 600; Week 52 >600
|
0 Participants
|
0 Participants
|
|
Shift in Platelet Counts From Baseline to Selected Visits (LOCF)
Baseline >600; Week 52 <= 100
|
0 Participants
|
0 Participants
|
|
Shift in Platelet Counts From Baseline to Selected Visits (LOCF)
Baseline >600; Week 52 >100 - <= 600
|
0 Participants
|
0 Participants
|
|
Shift in Platelet Counts From Baseline to Selected Visits (LOCF)
Baseline >600; Week 52 >600
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and during and up to 14 days after last dose of study drug (in Week 52)Population: All participants who received at least 1 dose of double-blind study medication.
Marked abnormality=a laboratory value lying outside the predefined criteria and more extreme (farther from the limit)on-treatment than at baseline. ULN=upper limit of normal; LLN=lower limit of normal; prx=pre-RX=pretreatment. Criteria 1: if prx=0 use \>=2, if prx=0.5 or 1 use \>=3, if prx=2 use 4.
Outcome measures
| Measure |
Saxagliptin, 5 mg + Insulin
n=304 Participants
Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
Placebo + Insulin
n=151 Participants
Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
|---|---|---|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Lymphocytes <=0.75*1000 c/uL (n=296; 150)
|
3 Participants
|
2 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Aspartate aminotransferase >20*ULN (n=298; 148)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Bilirubin, total >2 mg/dL (n=301; 150)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Blood urea nitrogen >2*prx & >ULN (n=302; 150)
|
5 Participants
|
7 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Glucose, serum fasting <50 mg/dL (n=0; 0)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Glucose, serum unspecified >500 mg/dL (n=0; 0)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Blood urine (see criteria 1) (n=297; 146)
|
14 Participants
|
2 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Hemoglobin <8 g/dL (n=300; 150)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Hematocrit <0.75*prx (n=300; 150)
|
2 Participants
|
2 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Platelets <50*10^9 c/L (n=297; 145)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Platelets >1.5*ULN (n=297; 145)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Leukocytes <2*1000 c/uL (n=300; 150)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Neutrophils <1*1000 c/uL (n=296; 150)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Eosinophils >0.9*1000 c/uL (n=296; 150)
|
9 Participants
|
7 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Alkaline phosphatase >3*prx & >ULN (n=302; 150)
|
2 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Alkaline phosphatase >1.5 ULN (n=302; 150)
|
10 Participants
|
5 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Aspartate aminotransferase >3* ULN (n=298; 148)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Aspartate aminotransferase>5* ULN (n=298; 148)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Aspartate aminotransferase >10*ULN (n=298; 148)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Alanine transaminase >3*ULN (n=300; 148)
|
5 Participants
|
3 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Alanine transaminase >5*ULN (n=300; 148)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Alanine transaminase >10*ULN (n=300; 148)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Alanine transaminase >20*ULN (n=300; 148)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Bilirubin, total >1.5*ULN (n=301; 150)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Bilirubin, total >2*ULN (n=301; 150)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Creatinine >2.5 mg/dL (n=303; 150)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Glucose, serum fasting >500 mg/dL (n=0; 0)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Glucose, serum unspecified <50 mg/dL (n=0; 0)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Glucose, plasma fasting <50 mg/dL (n=301;150)
|
5 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Glucose, plasma fasting >500 mg/dL (n=301;150)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Glucose, plasma unspecified <50 mg/dL (n=272; 133)
|
5 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Glucose, plasma unspecified >500 mg/d (n=272; 133)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Sodium, serum <0.9*prx & <=130 mEq/L (n=302; 150)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Sodium, serum >1.1*prx & >=150 mEq/L (n=302; 150)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Potassium, serum <0.8 prx &<=3.2 mEq/L(n=300; 148)
|
3 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Potassium, serum >1.2*prx&>= 6.0 mEq/L(n=300; 148)
|
8 Participants
|
8 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Chloride, serum <90 mEq/L (n=302; 150)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Chloride, serum >120 mEq/L (n=302; 150)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Albumin <0.9*LLN; if prx<LLN, 0.75*prx (n=302,150)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Creatine kinase >5*ULN (n=301, 148)
|
6 Participants
|
2 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Uric acid >1.5*ULN; if prx >ULN, >2 (n=0,0)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Protein urine (see criteria 1) (n=297,146)
|
8 Participants
|
3 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
Red blood cells urine (see criteria 1) (n=53; 31)
|
8 Participants
|
3 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period
White blood cells urine (see criteria 1)(n=115;53)
|
35 Participants
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52Confirmed hypoglycemia=fingerstick glucose measurement of ≤50 mg/dL with associated symptoms/
Outcome measures
| Measure |
Saxagliptin, 5 mg + Insulin
n=300 Participants
Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
Placebo + Insulin
n=149 Participants
Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
|---|---|---|
|
Percentage of Participants With Reported and Confirmed Hypoglycemia
Reported
|
19.4 Percentage of Participants
|
24.5 Percentage of Participants
|
|
Percentage of Participants With Reported and Confirmed Hypoglycemia
Confirmed
|
7.6 Percentage of Participants
|
6.6 Percentage of Participants
|
Adverse Events
Placebo + Insulin
Serious events: 13 serious events
Other events: 64 other events
Deaths: 0 deaths
Saxagliptin, 5 mg + Insulin
Serious events: 25 serious events
Other events: 96 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + Insulin
n=151 participants at risk
Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
Saxagliptin, 5 mg + Insulin
n=304 participants at risk
Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
|---|---|---|
|
Eye disorders
DIABETIC RETINOPATHY
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/151 • Baseline to Week 52
|
0.66%
2/304 • Baseline to Week 52
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Cardiac disorders
CORONARY ARTERY OCCLUSION
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
0.66%
1/151 • Baseline to Week 52
|
0.00%
0/304 • Baseline to Week 52
|
|
Vascular disorders
PERIPHERAL VASCULAR DISORDER
|
0.66%
1/151 • Baseline to Week 52
|
0.00%
0/304 • Baseline to Week 52
|
|
Vascular disorders
THROMBOPHLEBITIS SUPERFICIAL
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Hepatobiliary disorders
JAUNDICE
|
0.66%
1/151 • Baseline to Week 52
|
0.00%
0/304 • Baseline to Week 52
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.66%
1/151 • Baseline to Week 52
|
0.00%
0/304 • Baseline to Week 52
|
|
Hepatobiliary disorders
CHOLANGITIS ACUTE
|
0.66%
1/151 • Baseline to Week 52
|
0.00%
0/304 • Baseline to Week 52
|
|
Nervous system disorders
SCIATICA
|
0.66%
1/151 • Baseline to Week 52
|
0.00%
0/304 • Baseline to Week 52
|
|
Nervous system disorders
THALAMIC INFARCTION
|
0.66%
1/151 • Baseline to Week 52
|
0.00%
0/304 • Baseline to Week 52
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.66%
1/151 • Baseline to Week 52
|
0.00%
0/304 • Baseline to Week 52
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Gastrointestinal disorders
PANCREATITIS CHRONIC
|
0.66%
1/151 • Baseline to Week 52
|
0.00%
0/304 • Baseline to Week 52
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Infections and infestations
BRONCHITIS
|
0.66%
1/151 • Baseline to Week 52
|
0.00%
0/304 • Baseline to Week 52
|
|
Infections and infestations
CELLULITIS
|
0.66%
1/151 • Baseline to Week 52
|
0.00%
0/304 • Baseline to Week 52
|
|
Infections and infestations
ABSCESS LIMB
|
1.3%
2/151 • Baseline to Week 52
|
0.00%
0/304 • Baseline to Week 52
|
|
Infections and infestations
DENGUE FEVER
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Infections and infestations
OSTEOMYELITIS
|
0.66%
1/151 • Baseline to Week 52
|
0.00%
0/304 • Baseline to Week 52
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Infections and infestations
ARTHRITIS INFECTIVE
|
0.66%
1/151 • Baseline to Week 52
|
0.00%
0/304 • Baseline to Week 52
|
|
Infections and infestations
INTESTINAL GANGRENE
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.66%
1/151 • Baseline to Week 52
|
0.00%
0/304 • Baseline to Week 52
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.66%
1/151 • Baseline to Week 52
|
0.00%
0/304 • Baseline to Week 52
|
|
Blood and lymphatic system disorders
ANAEMIA VITAMIN B12 DEFICIENCY
|
0.66%
1/151 • Baseline to Week 52
|
0.00%
0/304 • Baseline to Week 52
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
0.66%
1/151 • Baseline to Week 52
|
0.00%
0/304 • Baseline to Week 52
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/151 • Baseline to Week 52
|
0.66%
2/304 • Baseline to Week 52
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.66%
1/151 • Baseline to Week 52
|
0.00%
0/304 • Baseline to Week 52
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.66%
1/151 • Baseline to Week 52
|
0.00%
0/304 • Baseline to Week 52
|
|
General disorders
CHEST PAIN
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.66%
1/151 • Baseline to Week 52
|
0.00%
0/304 • Baseline to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PITUITARY TUMOUR
|
0.66%
1/151 • Baseline to Week 52
|
0.00%
0/304 • Baseline to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA
|
0.00%
0/151 • Baseline to Week 52
|
0.33%
1/304 • Baseline to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER METASTATIC
|
0.66%
1/151 • Baseline to Week 52
|
0.00%
0/304 • Baseline to Week 52
|
Other adverse events
| Measure |
Placebo + Insulin
n=151 participants at risk
Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
Saxagliptin, 5 mg + Insulin
n=304 participants at risk
Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
|
|---|---|---|
|
Vascular disorders
HYPERTENSION
|
5.3%
8/151 • Baseline to Week 52
|
2.6%
8/304 • Baseline to Week 52
|
|
Nervous system disorders
HEADACHE
|
4.0%
6/151 • Baseline to Week 52
|
5.9%
18/304 • Baseline to Week 52
|
|
Infections and infestations
INFLUENZA
|
9.3%
14/151 • Baseline to Week 52
|
3.3%
10/304 • Baseline to Week 52
|
|
Infections and infestations
BRONCHITIS
|
2.6%
4/151 • Baseline to Week 52
|
5.3%
16/304 • Baseline to Week 52
|
|
Infections and infestations
PHARYNGITIS
|
5.3%
8/151 • Baseline to Week 52
|
3.6%
11/304 • Baseline to Week 52
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.6%
10/151 • Baseline to Week 52
|
6.2%
19/304 • Baseline to Week 52
|
|
Infections and infestations
URINARY TRACT INFECTION
|
7.9%
12/151 • Baseline to Week 52
|
7.6%
23/304 • Baseline to Week 52
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
7.3%
11/151 • Baseline to Week 52
|
6.2%
19/304 • Baseline to Week 52
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
6.6%
10/151 • Baseline to Week 52
|
2.3%
7/304 • Baseline to Week 52
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
- Publication restrictions are in place
Restriction type: OTHER