| Methods |
Type of trial: efficacy trial
Allocation: randomised
Intervention model: parallel assignment
Masking: open‐label
Primary purpose: treatment |
| Participants |
Condition: T2DM
Enrollment: estimated 40 participants
Inclusion criteria: T2DM, HbA1c between 6.5% to 9.0%
Exclusion criteria: treated with insulin, renal dysfunction, history of heart failure and cerebrovascular disease, liver dysfunction, pulmonary dysfunction, pregnancy or lactation, history of side effects by thiazolidinediones or biguanides, judged inappropriate for this study by the physicians |
| Interventions |
Intervention(s): metformin
Comparator(s): pioglitazone |
| Outcomes |
Primary outcome(s): Insulin secretion and sensitivity, surrogate markers of atherosclerosis, adipocytokines, and appetite‐regulating hormones
Secondary outcome(s): —
Other outcome(s): — |
| Study details |
Trial identifier:JPRN-UMIN000000771 |
| Publication details |
Language of protocol: Japanese / English
Funding: non‐commercial (university)
Publication status: unpublished |
| Stated aim of study |
Quote: "To study multifactorial effects of pioglitazone and metformin on insulin secretion and sensitivity, surrogate markers of atherosclerosis, adipocytokines, and appetite‐regulating hormones in Type 2 diabetic 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. |
