Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000245-12 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To establish the bioequivalence between Glucobay ODT (Orally Disintegrating Tablet) 100 mg taken without or with water and the Glucobay standard tablet 100 mg taken with water.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT 100 mg; Day 1: oral sucrose load plus Glucobay ODT 100 mg taken without water |
|
| Arm 2 | Experimental | Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT 100 mg; Day 1: oral sucrose load plus Glucobay ODT 100 mg taken with water |
|
| Arm 3 | Active Comparator | Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay standard tablet 100 mg; Day 1: oral sucrose load plus Glucobay standard tablet 100 mg taken with water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acarbose (Glucobay ODT, BAYG5421) | Drug |
| ||
| Acarbose (Glucobay, BAYG5421) |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of postprandial maximum concentration (Cmax) of blood glucose following sucrose load with Glucobay (Day 1) and without Glucobay (Day 0) | within 4 hours after sucrose load | |
| Ratio of postprandial Area under curve from 0 to 4 hours (AUC(0-4)) of blood glucose following sucrose load with Glucobay (Day 1) and without Glucobay (Day 0) | within 4 hours after sucrose load |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in postprandial maximum concentration (Cmax) of blood glucose and serum insulin following sucrose load with acarbose (day 1) and without acarbose (day 0) | within 4 hours after sucrose load | |
| Difference in postprandial area under curve from 0 to 4 hours (AUC(0-4)) of blood glucose and serum insulin following sucrose load with acarbose (day 1) and without acarbose (day 0) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mönchengladbach | North Rhine-Westphalia | 41061 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| within 4 hours after sucrose load |
| Safety parameters | Adverse events (AEs), clinical chemistry, hematology, urinalysis, physical examination, systolic and diastolic blood pressure, pulse rate, electrocardiogram (ECG) | Assessed in pre study treatment, study treatment, and follow-up visits |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020909 | Acarbose |
| ID | Term |
|---|---|
| D014312 | Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided