| Methods |
Type of trial: efficacy trial
Allocation: randomised
Intervention model: parallel assignment
Masking: open‐label
Primary purpose: treatment |
| Participants |
Condition: T2DM
Enrollment: estimated 200 participants
Inclusion criteria: treated only with life style modification (or cessation of previous treatment for more than 1 month), obtained documented agreement, age between 20 to 35 years, HbA1c between 6.5% to 8.0%
Exclusion criteria: T1DM, diabetes by other aetiology, anti‐GAD antibody positive (over 1.5 U/mL), allergy towards sitagliptin or metformin, severe liver dysfunction, severe renal dysfunction, severe heart failure, poor prognosis condition (ex: malignancy), pregnancy or breast‐feeding woman, metabolic emergency (diabetic ketoacidosis, hyperosmolar hyperglycaemic state), insulin user, psychological disorder, hypoglycaemia unawareness, steroid user, other improper patient |
| Interventions |
Intervention(s): metformin (500 ‐ 1500 mg/day)
Comparator(s): sitagliptin (50 ‐ 100 mg/day) |
| Outcomes |
Primary outcome(s): change in C‐peptide response index during 3 years
Secondary outcome(s): duration to monotherapy failure, HbA1c, MAGE obtained from SMBG, new onset or progression of micro, macrovascular complication, HOMA‐β, HOMA‐R, proinsulin/insulin ratio, adverse event and body weight change
Other outcome(s): ‐ |
| Study details |
Trial identifier:JPRN-UMIN000003563 |
| Publication details |
Language of protocol: Japanese / English
Funding: other (non‐profit foundation)
Publication status: unpublished |
| Stated aim of study |
Quote: "To compare the effectiveness of beta cell reservation" |
| Notes |
Only the protocol is available. Marked as a study awaiting classification due to a lack of data to assess inclusion. Trial authors have been contacted. |
