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. 2020 Jun 5;2020(6):CD012906. doi: 10.1002/14651858.CD012906.pub2

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Publicationstatus: unpublished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