The primary purpose of this study is to evaluate the efficacy of voglibose versus acarbose combined with metformin in participants with type 2 diabetes mellitus (T2DM) by evaluating levels of glycosylated hemoglobin.
The drug being tested in this study is called voglibose. Voglibose is being tested to treat type 2 diabetes in people who have diabetes that is inadequately controlled on metformin alone. This study will look at glycemic control in people who take voglibose. The study will enroll 494 patients. All participants will be enrolled in a 2-week screening phase and a metformin run-in phase. Eligible participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups: * Metformin and Voglibose 0.2 mg * Metformin and Acarbose 50 mg All participants will be asked to take their current dose of metformin tablets and either voglibose or acarbose tablets three times a day throughout the study. This multi-center trial will be conducted in China. The overall time to participate in this study is up to 20 weeks and participants will make 8 visits to the clinic.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
494
Unnamed facility
Hefei, Anhui, China
Unnamed facility
Maanshan, Anhui, China
Unnamed facility
Beijing, Beijing Municipality, China
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit relative to baseline.
Time frame: Baseline, Week 12
Change From Baseline in HbA1c at Week 6
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 6 relative to baseline.
Time frame: Baseline and Week 6
Change From Baseline in Fasting Blood Glucose Over Time
The change between the fasting blood glucose value collected at weeks 6 and 12 or final visit relative to baseline.
Time frame: Baseline, Weeks 6 and 12
Change From Baseline in Postprandial Plasma Glucose (PPG) Over Time
The change between the value of glucose after 1 and 2 hours of meal, measured by the meal tolerance test collected at Weeks 6 and 12 or relative to baseline.
Time frame: 1 and 2 hours after meal at Baseline, Weeks 6 and 12
Change From Baseline in Fasting Insulin at Week 12
The change between the fasting insulin value collected at week 12 or final visit relative to baseline.
Time frame: Baseline, Week 12
Change From Baseline in Postprandial Serum Insulin at Week 12
The change from Baseline in postprandial serum insulin, after 1 and 2 hours of meal collected at Week 12 relative to baseline.
Time frame: 1 and 2 hours after meal at Baseline and Week 12
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Unnamed facility
Guangzhou, Guangdong, China
Unnamed facility
Shenzhen, Guangdong, China
Unnamed facility
Taishan, Guangdong, China
Unnamed facility
Zhuzhou, Hunan, China
Unnamed facility
Nanjing, Jiangsu, China
Unnamed facility
Xuzhou, Jiangsu, China
Unnamed facility
Changchun, Jilin, China
...and 8 more locations
Change From Baseline in Fasting Glucagon at Week 12
The change between the fasting glucagon value collected at week 12 or final visit relative to baseline.
Time frame: Baseline, Week 12
Change From Baseline in Postprandial Serum Glucagon at Week 12
The change from Baseline in postprandial serum glucagon, after 1 and 2 hours of meal collected at Week 12 relative to baseline.
Time frame: 1 and 2 hours after meal at Baseline and Week 12
Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance (HOMA IR) at Week 12
The change between the value of HOMA-IR collected at Week 12 and HOMA-IR collected at Baseline. HOMA IR measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR = fasting plasma insulin (µIU/mL) \* fasting plasma glucose (mmol/L) / 22.5. A higher number indicates a greater insulin resistance.
Time frame: Baseline, Week 12
Change From Baseline in Insulin Homeostatic Model Assessment Beta Cell Function (HOMA β) at Week 12
The change between the value of HOMA-beta cell function collected at Week 12 and HOMA-beta cell function collected at Baseline. The homeostatic model assessment estimates steady state beta cell function as a percentage of a normal reference population (%B). HOMA %B = 20 \* insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5.
Time frame: Baseline, Week 12
Change From Baseline in Body Weight Over Time
The change between body weight at weeks 2, 6 and 12 or relative to baseline.
Time frame: Baseline, Weeks 2, 6 and 12