Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes, anion-exchange resin
Brief summary
The objective of this study is to evaluate the efficacy of MCI-196 in patients with Type 2 Diabetes based on the changes in blood glucose-related parameters and safety after 12 weeks administration in double-blind, placebo-controlled manner. And in addition, the changes in lipid-related parameters are examined.
Interventions
DRUGMCI-196
Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
DRUGPlacebo of MCI-196 Tablet
Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients whose fasting blood glucose levels during the observation period are between 130mg/dL and 200mg/dL. * Patients whose HbA1c is 7.0% or above during the observation period.
Exclusion criteria
* Patients with serious cardiac, hepatic or renal complications. * Patients with serious diabetic complications. * Patients with complete biliary obstruction or ileus. * Pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting Plasma Glucose at Baseline | 0 weeks |
| Change From Baseline in Blood Glucose at Week 12 | 12 weeks (baseline to week 12) |
| Hemoglobin A1c (HbA1c) at Baseline | 0 weeks |
| Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12 | 12 weeks (baseline to week 12) |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12 | 12 weeks (baseline to week 12) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MCI-196 Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) | 92 |
| Placebo Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration | 91 |
| Total | 183 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 2 |
| Overall Study | Physician Decision | 1 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | MCI-196 | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 32 Participants | 36 Participants | 68 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants | 55 Participants | 115 Participants |
| Sex: Female, Male Female | 33 Participants | 34 Participants | 67 Participants |
| Sex: Female, Male Male | 59 Participants | 57 Participants | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 53 / 92 | 46 / 91 |
| serious Total, serious adverse events | 1 / 92 | 5 / 91 |
Outcome results
Primary
Change From Baseline in Blood Glucose at Week 12
Time frame: 12 weeks (baseline to week 12)
Population: Per protocol set; Last observation carried forward
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCI-196 | Change From Baseline in Blood Glucose at Week 12 | -21.3 mg/dL | Standard Error 2.2 |
| Placebo | Change From Baseline in Blood Glucose at Week 12 | 0.8 mg/dL | Standard Error 2.2 |
Primary
Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12
Time frame: 12 weeks (baseline to week 12)
Population: Per protocol set; Last observation carried forward
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCI-196 | Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12 | -0.70 percentage | Standard Error 0.06 |
| Placebo | Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12 | 0.18 percentage | Standard Error 0.06 |
Primary
Fasting Plasma Glucose at Baseline
Time frame: 0 weeks
Population: Per protocol set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCI-196 | Fasting Plasma Glucose at Baseline | 170.2 mg/dL | Standard Deviation 21.1 |
| Placebo | Fasting Plasma Glucose at Baseline | 168.2 mg/dL | Standard Deviation 20.5 |
Primary
Hemoglobin A1c (HbA1c) at Baseline
Time frame: 0 weeks
Population: Per protocol set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCI-196 | Hemoglobin A1c (HbA1c) at Baseline | 7.97 percentage | Standard Deviation 0.72 |
| Placebo | Hemoglobin A1c (HbA1c) at Baseline | 7.94 percentage | Standard Deviation 0.77 |
Secondary
Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12
Time frame: 12 weeks (baseline to week 12)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCI-196 | Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12 | -28.9 mg/dL | Standard Error 2 |
| Placebo | Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12 | -0.2 mg/dL | Standard Error 2 |