Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes Mellitus, HbA1c
Brief summary
The purpose of this study is to evaluate the safety and efficacy of KAD-1229 as combination therapy with insulin for 16 weeks and up to 52 weeks administration in patients with type 2 Diabetes Mellitus who show inadequate glycemic control with diet, and insulin monotherapy, or insulin and oral hypoglycemic agent.
Interventions
Sponsors
Kissei Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Inclusion criteria
* Patients who has been receiving dietary therapy and a stable dose and regimen of insulin over 8 weeks before at the time of an observation term start * Patients whose HbA1c at the time of an observation term start is 7.5% or more and less than 10.0%
Exclusion criteria
* Type 1 Diabetes Mellitus * Patients with serious diabetic complications and other serious complications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in HbA1c | 16 weeks |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo/KAD-1229 Patients are administered Placebo for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with Insulin throughout the study.
KAD-1229
Placebo
Insulin | 60 |
| KAD-1229/KAD-1229 Patients are administered KAD-1229 for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with insulin throughout the study.
KAD-1229
Insulin | 118 |
| Total | 178 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double-blind Period | Adverse Event | 1 | 2 |
| Double-blind Period | Lack of Efficacy | 1 | 0 |
| Double-blind Period | Physician Decision | 0 | 1 |
| Double-blind Period | Withdrawal by Subject | 1 | 1 |
| Open-label Period | Adverse Event | 3 | 4 |
| Open-label Period | Lack of Efficacy | 4 | 19 |
| Open-label Period | Protocol Violation | 0 | 1 |
| Open-label Period | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | KAD-1229/KAD-1229 | Placebo/KAD-1229 |
|---|---|---|---|
| Age, Continuous | 58.6 years STANDARD_DEVIATION 10.9 | 59.7 years STANDARD_DEVIATION 10.3 | 56.5 years STANDARD_DEVIATION 11.7 |
| HbA1c | 8.50 % STANDARD_DEVIATION 0.75 | 8.48 % STANDARD_DEVIATION 0.7 | 8.54 % STANDARD_DEVIATION 0.85 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 178 Participants | 118 Participants | 60 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 48 Participants | 39 Participants | 9 Participants |
| Sex: Female, Male Male | 130 Participants | 79 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 118 | 0 / 175 |
| other Total, other adverse events | 19 / 60 | 28 / 118 | 98 / 175 |
| serious Total, serious adverse events | 2 / 60 | 4 / 118 | 18 / 175 |
Outcome results
Primary
Change From Baseline in HbA1c
Time frame: 16 weeks
Population: full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/KAD-1229 | Change From Baseline in HbA1c | 0.05 % (value of HbA1c) | Standard Deviation 1.04 |
| KAD-1229/KAD-1229 | Change From Baseline in HbA1c | -0.61 % (value of HbA1c) | Standard Deviation 0.87 |
p-value: <0.00195% CI: [-0.95, -0.37]t-test, 2 sided