Trial Outcomes & Findings for Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus (NCT NCT00885378)
NCT ID: NCT00885378
Last Updated: 2015-06-01
Results Overview
Mean change was adjusted for baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
166 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2015-06-01
Participant Flow
Participants at 43 sites in 4 countries (25 sites in the United States \[US\], 9 in Germany, 5 in Hungary, and 4 in Puerto Rico) received study medication and participated in this study.
Of the 166 subjects who entered the lead-in period, 6 discontinued: 3 withdrawal of consent, 1 poor/noncompliance, 1 adverse event (AE; abdominal pain secondary to partial small bowel obstruction), and 1 elevated liver enzymes that did not meet study exclusion criteria but was discontinued by the investigator.
Participant milestones
| Measure |
Saxagliptin 2.5 mg + Metformin Immediate Release (IR)
Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
|
Placebo + Metformin IR
2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
86
|
|
Overall Study
COMPLETED
|
66
|
78
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
Reasons for withdrawal
| Measure |
Saxagliptin 2.5 mg + Metformin Immediate Release (IR)
Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
|
Placebo + Metformin IR
2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Poor/Noncompliance
|
2
|
2
|
|
Overall Study
Protocol Violation
|
2
|
0
|
Baseline Characteristics
Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Saxagliptin 2.5 mg + Metformin Immediate Release (IR)
n=74 Participants
Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
|
Placebo + Metformin IR
n=86 Participants
2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.90 years
STANDARD_DEVIATION 10.35 • n=5 Participants
|
56.60 years
STANDARD_DEVIATION 9.97 • n=7 Participants
|
55.4 years
STANDARD_DEVIATION 10.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 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
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
144 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
56 participants
n=7 Participants
|
105 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
9 participants
n=5 Participants
|
12 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Mean Height
|
168.38 cm
STANDARD_DEVIATION 9.56 • n=5 Participants
|
167.77 cm
STANDARD_DEVIATION 8.99 • n=7 Participants
|
168.05 cm
STANDARD_DEVIATION 9.23 • n=5 Participants
|
|
Mean Weight
|
95.85 kg
STANDARD_DEVIATION 21.40 • n=5 Participants
|
91.74 kg
STANDARD_DEVIATION 19.87 • n=7 Participants
|
93.64 kg
STANDARD_DEVIATION 20.63 • n=5 Participants
|
|
Mean Body Mass Index (BMI)
|
33.68 kg / m^2
STANDARD_DEVIATION 5.94 • n=5 Participants
|
32.51 kg / m^2
STANDARD_DEVIATION 6.18 • n=7 Participants
|
33.05 kg / m^2
STANDARD_DEVIATION 6.08 • n=5 Participants
|
|
Participant Body Mass Index
< 30 kg / m^2
|
19 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Participant Body Mass Index
>= 30 kg / m^2
|
55 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Mean Duration of Type 2 Diabetes Mellitus
|
5.81 Years
STANDARD_DEVIATION 6.37 • n=5 Participants
|
6.17 Years
STANDARD_DEVIATION 4.21 • n=7 Participants
|
6.00 Years
STANDARD_DEVIATION 5.30 • n=5 Participants
|
|
Mean Metformin Dose at Baseline
|
1911.5 mg
STANDARD_DEVIATION 376.59 • n=5 Participants
|
1855.8 mg
STANDARD_DEVIATION 330.19 • n=7 Participants
|
1881.6 mg
STANDARD_DEVIATION 352.38 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants with both a baseline value and post-baseline value (up to Week 12).
Mean change was adjusted for baseline.
Outcome measures
| Measure |
Saxagliptin 2.5 mg + Metformin Immediate Release (IR)
n=74 Participants
Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
|
Placebo + Metformin IR
n=84 Participants
2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
|
|---|---|---|
|
Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12
Adjusted Mean Change From Baseline
|
-0.56 Percentage of glycosylated hemoglobins
Standard Error 0.09
|
-0.22 Percentage of glycosylated hemoglobins
Standard Error 0.08
|
|
Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12
Baseline
|
7.92 Percentage of glycosylated hemoglobins
Standard Error 0.11
|
7.97 Percentage of glycosylated hemoglobins
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Randomized participants with a measurement at the specified timepoint with Last Observation Carried Forward (LOCF).
Mean change was adjusted for baseline.
Outcome measures
| Measure |
Saxagliptin 2.5 mg + Metformin Immediate Release (IR)
n=73 Participants
Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
|
Placebo + Metformin IR
n=84 Participants
2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
|
|---|---|---|
|
Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG)
Mean Baseline
|
164.22 mg / dL
Standard Error 5.512
|
161.25 mg / dL
Standard Error 4.624
|
|
Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG)
Adjusted Mean Change from Baseline
|
-13.73 mg / dL
Standard Error 4.51
|
-4.22 mg / dL
Standard Error 4.20
|
SECONDARY outcome
Timeframe: Week 12Population: Randomized participants with measurement at timepoint with LOCF.
Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)
Outcome measures
| Measure |
Saxagliptin 2.5 mg + Metformin Immediate Release (IR)
n=73 Participants
Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
|
Placebo + Metformin IR
n=84 Participants
2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
|
|---|---|---|
|
Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12
|
37.5 Percentage of Participants
Interval 27.4 to 47.6
|
24.2 Percentage of Participants
Interval 15.8 to 32.7
|
SECONDARY outcome
Timeframe: Week 12Population: Randomized participants with measurement at timepoint with LOCF.
Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)
Outcome measures
| Measure |
Saxagliptin 2.5 mg + Metformin Immediate Release (IR)
n=74 Participants
Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
|
Placebo + Metformin IR
n=84 Participants
2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
|
|---|---|---|
|
Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12
|
24.6 Percentage of Participants
Interval 15.1 to 34.1
|
10.7 Percentage of Participants
Interval 4.6 to 16.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the double-blind (DB) period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.Population: All treated participants.
AE = any new untoward medical occurrence/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. Treatment-related=Possible, Probable, or Certain relationship to drug.
Outcome measures
| Measure |
Saxagliptin 2.5 mg + Metformin Immediate Release (IR)
n=74 Participants
Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
|
Placebo + Metformin IR
n=86 Participants
2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
|
|---|---|---|
|
Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary
At Least 1 AE
|
19 Participants
|
34 Participants
|
|
Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary
At Least 1 Related AE
|
1 Participants
|
3 Participants
|
|
Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary
Deaths
|
0 Participants
|
0 Participants
|
|
Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary
At Least 1 SAE
|
1 Participants
|
1 Participants
|
|
Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary
At Least 1 Related SAE
|
0 Participants
|
0 Participants
|
|
Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary
Discontinued Due to SAEs
|
0 Participants
|
0 Participants
|
|
Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary
Discontinued Due to AEs
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the DB period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.Population: All treated participants.
Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.
Outcome measures
| Measure |
Saxagliptin 2.5 mg + Metformin Immediate Release (IR)
n=74 Participants
Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
|
Placebo + Metformin IR
n=86 Participants
2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
|
|---|---|---|
|
Participants With Reported Hypoglycemia AEs During Double-Blind Treatment Period
|
4 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the DB period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.Population: All treated participants.
Confirmed hypoglycemia was defined by a fingerstick glucose value \<= 50 mg/dL with associated hypoglycemia symptoms.
Outcome measures
| Measure |
Saxagliptin 2.5 mg + Metformin Immediate Release (IR)
n=74 Participants
Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
|
Placebo + Metformin IR
n=86 Participants
2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
|
|---|---|---|
|
Participants With Confirmed Hypoglycemia
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12Population: All treated participants, excluding those with missing values.
Abnormal ECGs were defined as those not within the normal limits for the participant, according to the investigator. 'Shifted Normal to Abnormal' and 'Shifted Abnormal to Normal' references a change from measurements at Baseline to those at Week 12.
Outcome measures
| Measure |
Saxagliptin 2.5 mg + Metformin Immediate Release (IR)
n=71 Participants
Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
|
Placebo + Metformin IR
n=78 Participants
2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
|
|---|---|---|
|
Participant Electrocardiogram (ECG) Status at Baseline and Week 12
Week 12 Normal
|
39 Participants
|
50 Participants
|
|
Participant Electrocardiogram (ECG) Status at Baseline and Week 12
Week 12 Abnormal
|
32 Participants
|
28 Participants
|
|
Participant Electrocardiogram (ECG) Status at Baseline and Week 12
Baseline Abnormal
|
35 Participants
|
36 Participants
|
|
Participant Electrocardiogram (ECG) Status at Baseline and Week 12
Baseline Normal
|
36 Participants
|
42 Participants
|
|
Participant Electrocardiogram (ECG) Status at Baseline and Week 12
Shifted Normal to Abnormal
|
5 Participants
|
4 Participants
|
|
Participant Electrocardiogram (ECG) Status at Baseline and Week 12
Shifted Abnormal to Normal
|
8 Participants
|
12 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4, Week 8, Week 12Population: All treated participants. n= number of participants with measurement at time point.
Baseline values reference the measurement for the cohort of participants evaluated at the given time point.
Outcome measures
| Measure |
Saxagliptin 2.5 mg + Metformin Immediate Release (IR)
n=74 Participants
Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
|
Placebo + Metformin IR
n=86 Participants
2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
|
|---|---|---|
|
Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP Change From Baseline at Week 4 (n=74, 84)
|
-0.47 mm Hg
Standard Error 1.43
|
0.17 mm Hg
Standard Error 1.16
|
|
Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP Change From Baseline at Week 4 (n=74, 84)
|
-0.81 mm Hg
Standard Error 0.84
|
0.95 mm Hg
Standard Error 0.86
|
|
Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP Change From Baseline at Week 12 (n=66, 77)
|
1.59 mm Hg
Standard Error 1.51
|
0.83 mm Hg
Standard Error 1.26
|
|
Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP Change From Baseline at Week 12 (n=66, 77)
|
1.03 mm Hg
Standard Error 0.75
|
1.29 mm Hg
Standard Error 0.85
|
|
Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline SBP for Week 4 cohort (n=74, 84)
|
128.89 mm Hg
Standard Error 1.67
|
127.57 mm Hg
Standard Error 1.53
|
|
Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline DBP for Week 4 cohort (n=74, 84)
|
78.99 mm Hg
Standard Error 1.07
|
77.07 mm Hg
Standard Error 1.05
|
|
Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline SBP for Week 8 cohort (n=70, 81)
|
128.33 mm Hg
Standard Error 1.67
|
127.60 mm Hg
Standard Error 1.57
|
|
Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline DBP for Week 8 cohort (n=70, 81)
|
78.87 mm Hg
Standard Error 1.08
|
77.32 mm Hg
Standard Error 1.03
|
|
Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP Change From Baseline at Week 8 (n=70, 81)
|
0.60 mm Hg
Standard Error 1.66
|
-0.43 mm Hg
Standard Error 1.48
|
|
Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP Change From Baseline at Week 8 (n=70, 81)
|
0.37 mm Hg
Standard Error 0.94
|
0.86 mm Hg
Standard Error 0.93
|
|
Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline SBP for Week 12 cohort (n=66, 77)
|
128.18 mm Hg
Standard Error 1.76
|
127.38 mm Hg
Standard Error 1.56
|
|
Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline DBP for Week 12 cohort (n=66, 77)
|
78.85 mm Hg
Standard Error 1.13
|
77.23 mm Hg
Standard Error 1.06
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4, Week 8, Week 12Population: All treated participants. n= number of participants with measurement at time point.
Baseline values reference the measurement for the cohort of participants evaluated at the given time point.
Outcome measures
| Measure |
Saxagliptin 2.5 mg + Metformin Immediate Release (IR)
n=74 Participants
Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
|
Placebo + Metformin IR
n=86 Participants
2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
|
|---|---|---|
|
Baseline and Mean Change From Baseline in Participant Heart Rate (HR)
Baseline HR for Week 4 cohort (n=74, 84)
|
73.45 mm Hg
Standard Error 1.072
|
73.77 mm Hg
Standard Error 0.968
|
|
Baseline and Mean Change From Baseline in Participant Heart Rate (HR)
HR Change From Baseline at Week 4 (n=74, 84)
|
0.97 mm Hg
Standard Error 0.881
|
1.18 mm Hg
Standard Error 0.778
|
|
Baseline and Mean Change From Baseline in Participant Heart Rate (HR)
Baseline HR for Week 8 cohort (n=70, 81)
|
73.51 mm Hg
Standard Error 1.091
|
73.56 mm Hg
Standard Error 0.990
|
|
Baseline and Mean Change From Baseline in Participant Heart Rate (HR)
HR Change From Baseline at Week 8 (n=70, 81)
|
2.70 mm Hg
Standard Error 0.914
|
0.28 mm Hg
Standard Error 0.727
|
|
Baseline and Mean Change From Baseline in Participant Heart Rate (HR)
Baseline HR for Week 12 cohort (n=66, 77)
|
73.71 mm Hg
Standard Error 1.142
|
73.55 mm Hg
Standard Error 1.035
|
|
Baseline and Mean Change From Baseline in Participant Heart Rate (HR)
HR Change From Baseline at Week 12 (n=66, 77)
|
0.61 mm Hg
Standard Error 1.061
|
0.60 mm Hg
Standard Error 0.866
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12Population: All treated participants.
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. ULN=upper limit of normal; LLN=lower limit of normal.
Outcome measures
| Measure |
Saxagliptin 2.5 mg + Metformin Immediate Release (IR)
n=74 Participants
Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
|
Placebo + Metformin IR
n=86 Participants
2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
|
|---|---|---|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Leukocytes < 2 x 10^3 c/uL
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Neutrophils < 1 x 10^3 c/uL
|
1 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Lymphocytes <= 0.75 x 10^3 c/uL
|
1 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Alkaline Phosphatase >3x prior to dosing and > ULN
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Alanine Aminotransferase > 5x ULN
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Total Bilirubin > 2 mg/dL
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Creatinine > 2.5 mg/dL
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Serum Sodium >1.1x pre-Rx and >= 150 mEq/L
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Serum Potassium <=0.8x pre-Rx and <= 3.2 mEq/L
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Serum Potassium >=1.2x pre-Rx and >= 6.0 mEq/L
|
1 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Serum Chloride <90 mEq/L
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Serum Chloride > 120 mEq/L
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Fasting Plasma Glucose > 500 mg/dL
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Plasma Glucose Unspecified < 50 mg/dL
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Plasma Glucose Unspecified > 500 mg/dL
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Hemoglobin < 8 g/dL
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Hematocrit < 0.75 prior to dosing
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Platelets < 50 x 10^9 c/L
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Platelets > 1.5 x ULN
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Eosinophils > 0.9 x 10^3 c/uL
|
0 Participants
|
2 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Aspartate Aminotransferase > 3x ULN
|
1 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Aspartate Aminotransferase > 5x ULN
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Alanine Aminotransferase > 3x ULN
|
1 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Total Bilirubin > 1.5x ULN
|
0 Participants
|
1 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Blood Urea Nitrogen > 2x prior to dosing and > ULN
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Serum Sodium <0.9x pre-Rx and <= 130 mEq/
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Albumin <0.9x LLN, or if pre-Rx<LLN use <0.75x
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Creatinine Kinase > 5x ULN
|
0 Participants
|
1 Participants
|
|
Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria
Fasting Plasma Glucose < 50 mg/dL
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12Population: All treated participants. N = number of participants analyzed and n = the number of participants with values available for each specific measurement.
Marked abnormality criteria were urine protein: if pre-Rx=o use \>=2, if pre-Rx =0.5 or 1 use \>=3, if pre-Rx =2, use \>=4; urine blood: if pre-Rx=0, use \>=2, if pre-Rx=0.5 or 1, use \>=3, if pre-Rx=2, use \>=4; Urine red blood cell count (RBC): if pre-Rx=o use \>=2, if pre-Rx =0.5 or 1 use \>=3, if pre-Rx =2, use \>=4; urine white blood cell count (WBC): if pre-Rx=o use \>=2, if pre-Rx =0.5 or 1 use \>=3, if pre-Rx =2, use \>=4.
Outcome measures
| Measure |
Saxagliptin 2.5 mg + Metformin Immediate Release (IR)
n=74 Participants
Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
|
Placebo + Metformin IR
n=86 Participants
2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
|
|---|---|---|
|
Participants Experiencing Changes From Baseline in Urinalysis Parameters That Met the Marked Abnormality Criteria
Urine Protein (n=74, 84)
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Urinalysis Parameters That Met the Marked Abnormality Criteria
Urine Red Blood Cells (n=7, 10)
|
0 Participants
|
0 Participants
|
|
Participants Experiencing Changes From Baseline in Urinalysis Parameters That Met the Marked Abnormality Criteria
Urine White Blood Cells (n=16, 18)
|
2 Participants
|
2 Participants
|
|
Participants Experiencing Changes From Baseline in Urinalysis Parameters That Met the Marked Abnormality Criteria
Urine Blood (n=74, 84)
|
1 Participants
|
1 Participants
|
Adverse Events
Placebo + Metformin IR
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Saxagliptin 2.5 mg + Metformin Immediate Release (IR)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + Metformin IR
n=86 participants at risk
2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
|
Saxagliptin 2.5 mg + Metformin Immediate Release (IR)
n=74 participants at risk
Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
|
|---|---|---|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/86
|
1.4%
1/74
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
1.2%
1/86
|
0.00%
0/74
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.00%
0/86
|
1.4%
1/74
|
Other adverse events
Adverse event data not reported
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