Type 2 Diabetes
Conditions
Keywords
Type 2 diabetes, HbA1c, Long-term study
Brief summary
The purpose of this study is to evaluate the long-term safety and efficacy of KAD-1229 as combination therapy with biguanide or DPP-4 inhibitor in type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy.
Interventions
DRUGKAD-1229
Sponsors
Kissei Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy * Age in the 20 years or over inclusive * HbA1c in the range of ≥ 6.5 to \< 9%
Exclusion criteria
* Type 1 diabetes mellitus * Patients with serious diabetic complications and other serious complications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidences of Adverse Events | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in HbA1c at 52 Weeks | at week 0 and week 52 |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| KAD-1229 / DPP-4 Inhibitors | 67 |
| KAD-1229 / Biguanides | 68 |
| Total | 135 |
Baseline characteristics
| Characteristic | KAD-1229 / DPP-4 Inhibitors | KAD-1229 / Biguanides | Total |
|---|---|---|---|
| Age, Continuous | 60.3 years STANDARD_DEVIATION 10.6 | 56.9 years STANDARD_DEVIATION 11.5 | 58.6 years STANDARD_DEVIATION 11.1 |
| HbA1c | 7.47 % STANDARD_DEVIATION 0.54 | 7.50 % STANDARD_DEVIATION 0.66 | 7.49 % STANDARD_DEVIATION 0.6 |
| Sex: Female, Male Female | 21 Participants | 18 Participants | 39 Participants |
| Sex: Female, Male Male | 46 Participants | 50 Participants | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 34 / 67 | 47 / 69 |
| serious Total, serious adverse events | 1 / 67 | 5 / 69 |
Outcome results
Primary
Incidences of Adverse Events
Time frame: 52 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| KAD-1229 / DPP-4 Inhibitors | Incidences of Adverse Events | 48 Participants |
| KAD-1229 / Biguanides | Incidences of Adverse Events | 57 Participants |
Secondary
Change From Baseline in HbA1c at 52 Weeks
Time frame: at week 0 and week 52
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KAD-1229 / DPP-4 Inhibitors | Change From Baseline in HbA1c at 52 Weeks | -0.45 percentage of HbA1c | Standard Deviation 0.69 |
| KAD-1229 / Biguanides | Change From Baseline in HbA1c at 52 Weeks | -0.28 percentage of HbA1c | Standard Deviation 0.63 |