Type 2 Diabetes Mellitus
Conditions
Keywords
insulin resistance
Brief summary
This extension study was designed to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes Mellitus. The extension study was an extension to double-blind study of 16 weeks (TA-7284-11)
Detailed description
This is an open-label extension study to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with insulin in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will enroll from the double-blind study of 16 weeks and receive TA-7284 100mg orally for 36 weeks.
Interventions
The patients will receive Canagliflozin orally for 36 weeks
DRUGInsulin
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients should complete the week 16 assessments in the double-blind study (TA-7284-11)
Exclusion criteria
* Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria * Patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy) * Patients with serious renal or hepatic disease * Patients who are the excessive alcohol addicts * Patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events) | Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percentage Change in Body Weight | Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks |
| Change in Percentage of HbA1c | Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks |
| Change in Fasting Plasma Glucose | Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks |
Countries
Japan
Participant flow
Pre-assignment details
The number of patients continued treatment in this study after TA-7284-11 study was 139. Four patients in the CANA/CANA group who did not continued this study were included in the analysis set. Analysis of this study was conducted 143 patients.
Participants by arm
| Arm | Count |
|---|---|
| Placebo/CANA + Insulin Canagliflozin(CANA) 100mg once daily for 36 weeks, followed placebo for 16 weeks in TA-7284-11 study | 67 |
| CANA/CANA + Insulin Canagliflozin(CANA) 100mg once daily for 36 weeks, followed Canagliflozin(CANA) for 16 weeks in TA-7284-11 study | 76 |
| Total | 143 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 4 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Stopping Criteria | 1 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Placebo/CANA + Insulin | CANA/CANA + Insulin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 21 Participants | 29 Participants | 50 Participants |
| Age, Categorical Between 18 and 65 years | 46 Participants | 47 Participants | 93 Participants |
| Sex: Female, Male Female | 21 Participants | 32 Participants | 53 Participants |
| Sex: Female, Male Male | 46 Participants | 44 Participants | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 49 / 67 | 56 / 75 |
| serious Total, serious adverse events | 7 / 67 | 7 / 75 |
Outcome results
Primary
Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)
Time frame: Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
Population: One patient of CANA/CANA group who mistakenly received placebo during TA-7284-11 study, did not continued this study. This patient was included in the full analysis set and was not included in the safety analysis set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo/CANA + Insulin | Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events) | Serious Adverse Event | 7 Participants |
| Placebo/CANA + Insulin | Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events) | Adverse Event | 57 Participants |
| CANA/CANA + Insulin | Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events) | Serious Adverse Event | 7 Participants |
| CANA/CANA + Insulin | Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events) | Adverse Event | 69 Participants |
Secondary
Change in Fasting Plasma Glucose
Time frame: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
Population: Full analysis set, last observation carried forward. Outcome measure for two patients of Placebo/CANA group and one patient of CANA/CANA group was not assessed at a certain timepoint due to dropout.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/CANA + Insulin | Change in Fasting Plasma Glucose | -33.1 mg/dL | Standard Deviation 44.1 |
| CANA/CANA + Insulin | Change in Fasting Plasma Glucose | -32.8 mg/dL | Standard Deviation 45.7 |
Secondary
Change in Percentage of HbA1c
Time frame: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
Population: Full analysis set, last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/CANA + Insulin | Change in Percentage of HbA1c | -1.09 percentage of HbA1c | Standard Deviation 0.85 |
| CANA/CANA + Insulin | Change in Percentage of HbA1c | -0.88 percentage of HbA1c | Standard Deviation 0.86 |
Secondary
Percentage Change in Body Weight
Time frame: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
Population: Full analysis set, last observation carried forward. Outcome measure for two patients of Placebo/CANA group and one patient of CANA/CANA group was not assessed at a certain timepoint due to dropout.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/CANA + Insulin | Percentage Change in Body Weight | -1.40 percent change | Standard Deviation 2.54 |
| CANA/CANA + Insulin | Percentage Change in Body Weight | -2.14 percent change | Standard Deviation 2.75 |