| Methods |
Type of trial: efficacy trial
Allocation: randomised
Intervention model: parallel assignment
Masking: single blinding (participants)
Primary purpose: treatment |
| Participants |
Condition: T2DM
Enrollment: estimated 90 participants
Inclusion criteria: aged 18 to 75 years old, newly diagnosed type 2 diabetes or poor controlled glycaemia with metformin alone or other one kind antidiabetic diabetes drug, HbA1c between 7% ‐ 10%, BMI < 35.
Exclusion criteria: impaired hepatic function with ALT higher than 3 X ULN, impaired renal function with serum creatinine higher than 1.5 mg/dL, myocardial infarction, stroke or TIA within 6 months prior to informed consent, use of insulin, rosiglitazone or pioglitazone, or GLP‐1 analogue within 3 months prior to informed consent. |
| Interventions |
Intervention(s): metformin (1500 mg/day)
Comparator(s): DPP‐IV inhibitor (5 mg/day) |
| Outcomes |
Primary outcome(s): adipocytokines, inflammation markers, vascular endothelial function
Secondary outcome(s): —
Other outcome(s): — |
| Study details |
Trial identifier:ChiCTR-TRC-11001331 |
| Publication details |
Language of protocol: Chinese / English
Funding: non‐commercial (government foundation)
Publication status: unclear if published |
| Stated aim of study |
Quote: "To investigate the effects of DPP‐Ⅳ inhibitor and/or metformin combination on adipokine, inflammation and vascular endothelial function in type 2 diabetes patients " |
| 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. |
