Diabetes Mellitus, Non-Insulin-Dependent
Conditions
Keywords
Type 2 DM
Brief summary
The efficacy and safety study of saxagliptin 5mg, once daily for 24 weeks in patients with type 2 diabetes mellitus.
Detailed description
A multicenter, single arm, cohort study to evaluate the Efficacy and Safety of saxagliptin 5mg, once daily for 24 weeks, in patients with type 2 diabetes mellitus who are treatment naive or who have inadequate glycaemic control on metformin alone
Interventions
DRUGSaxagliptin
oral, 5 mg once a day (Q.D.)
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Provision of informed consent prior to any study specific procedures Diagnosed with type 2 diabetes * Men or women who are \>18 years of age at time of consenting upon Visit 1 * HbA1c \>7.5% and ≤11.0% Patients should be drug naive or treated with metformin alone on stable doses of for at least continues 8 weeks prior to Visit 1 * Drug naive patients are defined as patients who have not received medical treatment for diabetes (insulin and/or oral hypo)
Exclusion criteria
* Pregnant or breastfeeding patients * Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes) * Previous treatment with any DPP-IV inhibitors or GLP-1 analogue * History of administration of any antihyperglycemic therapy (other than metformin) during the 8 weeks prior to Visit 1(12 weeks for previous TZD) * Treatment with systemic glucocorticoids other than replacement therapy * Inhaled, local injected and topical use of glucocorticoids is allowed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline in Haemoglobin A1c (HbA1c) | Weeks 6, 12, and 24 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Proportion (%) of Patients Achieving HbA1c <7% | Weeks 6, 12, and 24 |
| Change From Baseline in Fasting Plasma Glucose (FPG) | Weeks 6, 12, 18, and 24 |
| Change From Baseline in 2-hour Postprandial Plasma Glucose (2h-PPG) | Week 24 |
Countries
China
Participant flow
Recruitment details
This study was conducted at 92 study centers in China. First subject enrolled: 28 Nov 2012; Last subject last visit: 16 May 2014.
Pre-assignment details
A total of 2165 patients were screened and 741 patients were excluded due to violation of any inclusion and exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Saxagliptin Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks | 1,210 |
| Total | 1,210 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 29 |
| Overall Study | bood sugar too high, etc. | 3 |
| Overall Study | Lost to Follow-up | 41 |
| Overall Study | Protocol Violation | 6 |
| Overall Study | Safety reasons | 1 |
| Overall Study | Study-specific discontinuation criteria | 32 |
| Overall Study | Withdrawal by Subject | 131 |
Baseline characteristics
| Characteristic | Saxagliptin |
|---|---|
| Age, Continuous | 52.3 years STANDARD_DEVIATION 10.99 |
| Age, Customized <65 years | 1063 Participants |
| Age, Customized >=65 years | 147 Participants |
| Baseline fasting plasma glucose (FPG) | 9.08 mmol/L STANDARD_DEVIATION 2.244 |
| Baseline haemoglobin A1c (HbA1c) | 8.85 % STANDARD_DEVIATION 0.929 |
| Race/Ethnicity, Customized Asian | 1210 Participants |
| Race/Ethnicity, Customized Chinese | 1210 Participants |
| Sex: Female, Male Female | 461 Participants |
| Sex: Female, Male Male | 749 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 69 / 1,361 |
| serious Total, serious adverse events | 24 / 1,361 |
Outcome results
Primary
Absolute Change From Baseline in Haemoglobin A1c (HbA1c)
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.
Time frame: Weeks 6, 12, and 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saxagliptin | Absolute Change From Baseline in Haemoglobin A1c (HbA1c) | Week 6 | -1.19 (%) | Standard Error 0.033 |
| Saxagliptin | Absolute Change From Baseline in Haemoglobin A1c (HbA1c) | Week 12 | -1.59 (%) | Standard Error 0.039 |
| Saxagliptin | Absolute Change From Baseline in Haemoglobin A1c (HbA1c) | Week 24 | -1.61 (%) | Standard Error 0.04 |
Secondary
Change From Baseline in 2-hour Postprandial Plasma Glucose (2h-PPG)
Time frame: Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin | Change From Baseline in 2-hour Postprandial Plasma Glucose (2h-PPG) | -2.83 mmol/L | Standard Error 0.274 |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame: Weeks 6, 12, 18, and 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saxagliptin | Change From Baseline in Fasting Plasma Glucose (FPG) | Week 6 | -0.77 mmol/L | Standard Error 0.063 |
| Saxagliptin | Change From Baseline in Fasting Plasma Glucose (FPG) | Week 12 | -0.89 mmol/L | Standard Error 0.065 |
| Saxagliptin | Change From Baseline in Fasting Plasma Glucose (FPG) | Week 18 | -0.74 mmol/L | Standard Error 0.071 |
| Saxagliptin | Change From Baseline in Fasting Plasma Glucose (FPG) | Week 24 | -0.55 mmol/L | Standard Error 0.07 |
Secondary
Proportion (%) of Patients Achieving HbA1c <7%
Time frame: Weeks 6, 12, and 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Saxagliptin | Proportion (%) of Patients Achieving HbA1c <7% | Week 6 | 25.4 Percentage |
| Saxagliptin | Proportion (%) of Patients Achieving HbA1c <7% | Week 12 | 45.6 Percentage |
| Saxagliptin | Proportion (%) of Patients Achieving HbA1c <7% | Week 24 | 44.1 Percentage |