Trial Outcomes & Findings for The Efficacy and Safety Study in Patients With Type 2 Diabetes Mellitus (NCT NCT01608724)
NCT ID: NCT01608724
Last Updated: 2016-02-02
Results Overview
Evaluation after 24 weeks oral administration of saxagliptin treatment in patients with type 2 diabetes inadequately controlled with diet and exercise or with metformin in addition to diet and exercise.
COMPLETED
PHASE4
2165 participants
Weeks 6, 12, and 24
2016-02-02
Participant Flow
This study was conducted at 92 study centers in China. First subject enrolled: 28 Nov 2012; Last subject last visit: 16 May 2014.
A total of 2165 patients were screened and 741 patients were excluded due to violation of any inclusion and exclusion criteria.
Participant milestones
| Measure |
Saxagliptin
Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
|
|---|---|
|
Overall Study
STARTED
|
1423
|
|
Overall Study
Treated
|
1361
|
|
Overall Study
COMPLETED
|
1180
|
|
Overall Study
NOT COMPLETED
|
243
|
Reasons for withdrawal
| Measure |
Saxagliptin
Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
131
|
|
Overall Study
Lost to Follow-up
|
41
|
|
Overall Study
Study-specific discontinuation criteria
|
32
|
|
Overall Study
Adverse Event
|
29
|
|
Overall Study
Protocol Violation
|
6
|
|
Overall Study
bood sugar too high, etc.
|
3
|
|
Overall Study
Safety reasons
|
1
|
Baseline Characteristics
The Efficacy and Safety Study in Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Saxagliptin
n=1210 Participants
Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
|
|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 10.99 • n=5 Participants
|
|
Age, Customized
<65 years
|
1063 Participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
147 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
461 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
749 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1210 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
1210 Participants
n=5 Participants
|
|
Baseline haemoglobin A1c (HbA1c)
|
8.85 %
STANDARD_DEVIATION 0.929 • n=5 Participants
|
|
Baseline fasting plasma glucose (FPG)
|
9.08 mmol/L
STANDARD_DEVIATION 2.244 • n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 6, 12, and 24Population: Per-protocoal analysis set (PPS), including patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations.
Evaluation after 24 weeks oral administration of saxagliptin treatment in patients with type 2 diabetes inadequately controlled with diet and exercise or with metformin in addition to diet and exercise.
Outcome measures
| Measure |
Saxagliptin
n=1210 Participants
Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
|
|---|---|
|
Absolute Change From Baseline in Haemoglobin A1c (HbA1c)
Week 6
|
-1.19 (%)
Standard Error 0.033
|
|
Absolute Change From Baseline in Haemoglobin A1c (HbA1c)
Week 12
|
-1.59 (%)
Standard Error 0.039
|
|
Absolute Change From Baseline in Haemoglobin A1c (HbA1c)
Week 24
|
-1.61 (%)
Standard Error 0.040
|
SECONDARY outcome
Timeframe: Weeks 6, 12, and 24Population: Per-protocoal analysis set (PPS), including patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations.
Outcome measures
| Measure |
Saxagliptin
n=1210 Participants
Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
|
|---|---|
|
Proportion (%) of Patients Achieving HbA1c <7%
Week 6
|
25.4 Percentage
|
|
Proportion (%) of Patients Achieving HbA1c <7%
Week 12
|
45.6 Percentage
|
|
Proportion (%) of Patients Achieving HbA1c <7%
Week 24
|
44.1 Percentage
|
SECONDARY outcome
Timeframe: Weeks 6, 12, 18, and 24Population: Per-protocoal analysis set (PPS), including patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations.
Outcome measures
| Measure |
Saxagliptin
n=1210 Participants
Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
|
|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Week 6
|
-0.77 mmol/L
Standard Error 0.063
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Week 12
|
-0.89 mmol/L
Standard Error 0.065
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Week 18
|
-0.74 mmol/L
Standard Error 0.071
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Week 24
|
-0.55 mmol/L
Standard Error 0.070
|
SECONDARY outcome
Timeframe: Week 24Population: Patients who participated in standard noodle test in the per-protocoal analysis set (PPS), which included patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations.
Outcome measures
| Measure |
Saxagliptin
n=202 Participants
Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
|
|---|---|
|
Change From Baseline in 2-hour Postprandial Plasma Glucose (2h-PPG)
|
-2.83 mmol/L
Standard Error 0.274
|
Adverse Events
Saxagliptin
Serious adverse events
| Measure |
Saxagliptin
n=1361 participants at risk
Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
|
|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.15%
2/1361 • 24 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.07%
1/1361 • 24 weeks
|
|
Cardiac disorders
Angina unstable
|
0.07%
1/1361 • 24 weeks
|
|
Cardiac disorders
Arrhythmia
|
0.07%
1/1361 • 24 weeks
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.07%
1/1361 • 24 weeks
|
|
Cardiac disorders
Atrial flutter
|
0.07%
1/1361 • 24 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.07%
1/1361 • 24 weeks
|
|
Infections and infestations
Diabetic foot infection
|
0.07%
1/1361 • 24 weeks
|
|
Infections and infestations
Hepatitis B
|
0.07%
1/1361 • 24 weeks
|
|
Infections and infestations
Herpes zoster
|
0.07%
1/1361 • 24 weeks
|
|
Infections and infestations
Tuberculosis
|
0.07%
1/1361 • 24 weeks
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.07%
1/1361 • 24 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.07%
1/1361 • 24 weeks
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.07%
1/1361 • 24 weeks
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.15%
2/1361 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.15%
2/1361 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.07%
1/1361 • 24 weeks
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.07%
1/1361 • 24 weeks
|
|
Nervous system disorders
Cerebral infarction
|
0.07%
1/1361 • 24 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.15%
2/1361 • 24 weeks
|
|
Endocrine disorders
Hyperthyroidism
|
0.07%
1/1361 • 24 weeks
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.07%
1/1361 • 24 weeks
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.07%
1/1361 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.07%
1/1361 • 24 weeks
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.07%
1/1361 • 24 weeks
|
|
Surgical and medical procedures
Abortion induced
|
0.07%
1/1361 • 24 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.07%
1/1361 • 24 weeks
|
Other adverse events
| Measure |
Saxagliptin
n=1361 participants at risk
Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
|
|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
2.7%
37/1361 • 24 weeks
|
|
Nervous system disorders
Dizziness
|
2.6%
36/1361 • 24 weeks
|
Additional Information
Anya Huang, Brand Physician
Astrazeneca Investment (China) Co., Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60