NCT01303055.
| Methods |
Type of trial: efficacy trial Allocation: randomised Intervention model: parallel assignment Masking: none (open‐label) Primary purpose: treatment |
| Participants |
Condition: T2DM Enrollment: estimated 80 participants Inclusion criteria: T2DM, HbA1c level < 7.9%, no previous oral hypoglycaemic agents or insulin treatments for the past three months Exclusion criteria: 75 g OGTT 30‐minutes insulin secretion > 100 μU/mL, renal failure with serum creatinine level ≧ 1.2, hepatocirrhosis, proliferative diabetic retinopathy or worse, acute infectious disease, treated with steroids, cancer, pregnant, malfunction of the heart (NYHA classification III‐IV), inappropriate participants decided by study physicians |
| Interventions |
Intervention(s): metformin (2250 mg/day) Comparator(s): alogliptin (75 mg/day) |
| Outcomes |
Primary outcome(s): beta cell function evaluated from 75 g OGTT Secondary outcome(s): 1,5‐AG level Other outcome(s): — |
| Study details | Trial identifier: NCT01303055 |
| Publication details |
Language of publication / protocol: English Funding: non‐commercial (university) Publicationstatus: unpublished |
| Stated aim of study | — |
| Notes | Only the protocol is available. Trial authors have been contacted |