Yang 2009.
| Methods |
RANDOMISED CONTROLLED CLINICAL TRIAL (RCT): yes, parallel RCT RANDOMISATION RATIO: equal ratio assumed (not stated in manuscript) NON‐INFERIORITY DESIGN: no EQUIVALENCE DESIGN: no ETHICS APPROVAL OBTAINED: yes PATIENT CONSENT OBTAINED: yes BLINDING OF PATIENT (P), EDUCATOR (E), RESEARCHER (R): P = no, E = no, R = no ANALYSIS BY INTENTION TO TREAT: No POWER CALCULATION: no |
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| Participants |
WHO PARTCIPATED: SEX (female% / male%): Insulin group 42% F(5/12), 58% M 7/12, Insulin plus rosiglitazone 50% F (6/12), 50% M (6/12), SU group 43% F (6/14), 57% M (8/14), Rosiglitazone group 33% F(5/15), 66% M (10/15) 10M, 5F. AGE (mean years (SD)): Insulin group 48.5 (14.6), Insulin plus rosiglitazone 48.0 (12.8), SU group 50.0 (14.5), Rosiglitazone group 50.6 (11.8) ETHNIC GROUPS (%): not stated DURATION OF DISEASE (median months (range)): Insulin 1.35 (1.52), Insulin + rosiglitazone 1.5 (1.52), SU group 1.1 (1.31), Rosiglitazone 1.16 (1.46). INCLUSION CRITERIA: (1) No ketosis within the first 6 months after diagnosis (2) disease duration less than 5 years (3) FCP level of 0.2 nmol/L or more (4) diet alone can not achieve glycaemic control. EXCLUSION CRITERIA: impaired liver, kidney or heart function or other severe diseases. DIAGNOSTIC CRITERIA: type 2 diabetes diagnosed as LADA CO‐MORBIDITIES:Not given CO‐MEDICATIONS: Not given NUMBER: Insulin 12, Insulin + rosiglitazone 12, SU 14, Rosiglitazone 15. LOSS TO FOLLOW‐UP: 0% |
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| Interventions |
NUMBER OF STUDY CENTRES:not reported COUNTRY/ LOCATION: China SETTING: out‐patient INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY): Patients with GADA <175 and FCP >0.3 nmol/L were randomised to SU. Patinets with GADA<175 U/ml and FCP <0.3 nmol/L were assigned subcutaneous insulin with rosiglitazone 4 mg/d. CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY): Patients with GADA <175 and FCP>0.3 nmol/L were randomised to rosiglitazone 4 mg/d. Patients with GADA <175 U/ml and FCP <0.3 nmol/L were assigned subcutaneous insulin therapy TREATMENT BEFORE STUDY:None TITRATION PERIOD: None. |
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| Outcomes |
PRIMARY OUTCOME(S) (as stated in the publication):Not stated but objectives states "to clarify whether LADA benefit from rosiglitazone treatment" SECONDARY OUTCOMES (as stated in the publication):Not stated ADDITIONAL OUTCOMES: 1.HbA1c, 2. FBG, 3. Stimulated C‐peptide and changes in C‐peptide |
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| Study details |
DURATION OF INTERVENTION: 36 months DURATION OF FOLLOW‐UP: 36 months RUN‐IN PERIOD: none |
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| Publication details |
LANGUAGE OF PUBLICATION: English COMMERCIAL FUNDING: no NON‐COMMERCIAL FUNDING: yes PUBLICATION STATUS (PEER REVIEW JOURNAL): yes PUBLICATION STATUS (JOURNAL SUPPLEMENT): no PUBLICATION STATUS (ABSTRACT): Full paper |
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| Stated aim for study | Quote "" To clarify whether LADA benefit from rosiglitazone" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Low risk | Unblinded |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | No evidence the analyst was blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No problems identified |
| Selective reporting (reporting bias) | Low risk | No problems identified |
| Other bias | Low risk | No problems identified |