| Trial ID: | L4842 |
| Source ID: | NCT02049814
|
| Associated Drug: |
Metformin
|
| Title: |
Efficacy and Safety of Voglibose Compared With Acarbose in Participants With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02049814/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Metformin|DRUG: Voglibose|DRUG: Acarbose
|
| Outcome Measures: |
Primary: 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., Baseline, Week 12 | Secondary: 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., 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., 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., 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., 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., 1 and 2 hours after meal at Baseline and Week 12|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., 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., 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., 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., 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., Baseline, Weeks 2, 6 and 12
|
| Sponsor/Collaborators: |
Sponsor: Takeda
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
494
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2014-05-09
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| Completion Date: |
2016-06-28
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| Results First Posted: |
2019-02-04
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| Last Update Posted: |
2019-03-13
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| Locations: |
Hefei, Anhui, China|Maanshan, Anhui, China|Beijing, Beijing, China|Guangzhou, Guangdong, China|Shenzhen, Guangdong, China|Taishan, Guangdong, China|Zhuzhou, Hunan, China|Nanjing, Jiangsu, China|Xuzhou, Jiangsu, China|Changchun, Jilin, China|Jilin, Jilin, China|Shenyang, Liaoning, China|Qingdao, Shandong, China|Shanghai, Shanghai, China|Yan An, Shanxi, China|Yanan, Shanxi, China|Tianjin, Tianjin, China|Wenzhou, Zhejiang, China
|
| URL: |
https://clinicaltrials.gov/show/NCT02049814
|
