Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bayer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an evaluation of the effect of acarbose to delay worsening of fasting glucose control in early Type 2 diabetes mellitus.
A double blind, randomized, placebo-controlled clinical trial of acarbose in subjects with type 2 diabetes (an FDA-approved indication). Subjects were identified who had diabetes by glucose tolerance test criteria but non-diabetic fasting glucose concentrations. Treatment interventions were assessed for their ability to delay worsening of fasting glucose control.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acarbose | Experimental | acarbose 100 mg once daily |
|
| Placebo | Placebo Comparator | Matched placebo was administered for acarbose 100 mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acarbose | Drug | acarbose 100 mg PO once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression of fasting glucose >140 mg/dL | Fasting plasma glucose was measured quarterly for up to 5 years. Two consecutive measures above 140 mg/dL defined progression. | From date of randomization until the date of first documented progression or censoring, up to 5 years post randomization |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kieren J Mather, MD | Indiana University | Principal Investigator |
| Robert V Considine, PhD | Indiana University | Principal Investigator |
| Marian S Kirkman, MD | Indiana University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Hospital GCRC | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16936159 | Result | Kirkman MS, Shankar RR, Shankar S, Shen C, Brizendine E, Baron A, McGill J. Treating postprandial hyperglycemia does not appear to delay progression of early type 2 diabetes: the Early Diabetes Intervention Program. Diabetes Care. 2006 Sep;29(9):2095-101. doi: 10.2337/dc06-0061. | |
| 27533307 | Derived | Patel YR, Kirkman MS, Considine RV, Hannon TS, Mather KJ. Changes in Weight and Glucose Can Protect Against Progression in Early Diabetes Independent of Improvements in beta-Cell Function. J Clin Endocrinol Metab. 2016 Nov;101(11):4076-4084. doi: 10.1210/jc.2016-2056. Epub 2016 Aug 17. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020909 | Acarbose |
| ID | Term |
|---|---|
| D014312 | Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | acarbose placebo |
|
| 24819707 | Derived | Hannon TS, Kirkman MS, Patel YR, Considine RV, Mather KJ. Profound defects in beta-cell function in screen-detected type 2 diabetes are not improved with glucose-lowering treatment in the Early Diabetes Intervention Program (EDIP). Diabetes Metab Res Rev. 2014 Nov;30(8):767-76. doi: 10.1002/dmrr.2553. |
| D004700 | Endocrine System Diseases |