Maruyama 2003.
| Methods |
RANDOMISED CONTROLLED CLINICAL TRIAL (RCT): yes, parallel RANDOMISATION RATIO: equal ratio assumed (not stated in manuscript) NON‐INFERIORITY DESIGN: no EQUIVALENCE DESIGN: no ETHICS APPROVAL OBTAINED: unclear PATIENT CONSENT OBTAINED: unclear BLINDING OF PATIENT (P), EDUCATOR (E), RESEARCHER (R): P = no, E = no, R = unclear ANALYSIS BY INTENTION TO TREAT: No, not stated in the manuscript POWER CALCULATION: no |
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| Participants |
WHO PARTCIPATED: SEX (female% / male%): Insulin 37.5%F (9/24): 62.5% M (15/24), SU 53% F (16/30) : 47% M(14/30) AGE (mean years (SD)): Insulin: 56.6 years (13.4), SU 50.4 yrs (14.1) ETHNIC GROUPS (%): not stated DURATION OF DISEASE (mean years (SD)): insulin 2.7 yrs (3.8), SU 2.4 yrs (2.9) INCLUSION CRITERIA: (1) diagnosis of diabetes according to ADA criteria (2) not treated with insulin at least 6 months after diagnosis of diabetes (3) positive GADA in 2 samples taken within 2 months (4) disease duration < 10 years (5) patients were unrelated EXCLUSION CRITERIA: (1) history of ketonuria, diabetic ketoacidosis, marked hyperglycaemia requiring insulin, (2) renal or hepatic dysfunction affecting C‐peptide clearance and glucose tolerance, DIAGNOSTIC CRITERIA: Diabetes diagnosed according to American Diabetes Association (ADA) standards CO‐MORBIDITIES:Not given CO‐MEDICATIONS: Not given NUMBER: Insulin 24, SU 30 LOSS TO FOLLOW‐UP: unclear 54 reported at baseline but 56 reported at 48 months. Assumed typo and 54 participants with no loss of follow‐up. |
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| Interventions |
NUMBER OF STUDY CENTRES:7 COUNTRY/ LOCATION: Japan SETTING: out‐patient INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY): subcutaneous insulin therapy CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY): sulphonylurea (glibenclamide) 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 the frequency of GADA positive patients with non insulin requiring diabetes" SECONDARY OUTCOMES (as stated in the publication):Not stated but objectives states "to clarify the natural course of these GADA positive patients and to know the preventive effect of insulin on progressive beta cell failure" ADDITIONAL OUTCOMES: Collected at baseline and 4 years. 1. Stimulated C‐peptide and change in C‐peptide response (ng/ml), 2. Blood glucose, 3. HbA1c (%), 4. GADA (U/ml) |
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| Study details |
DURATION OF INTERVENTION: 4 years DURATION OF FOLLOW‐UP: 4 years (with 3‐monthly assessments) RUN‐IN PERIOD: None |
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| Publication details |
LANGUAGE OF PUBLICATION: English COMMERCIAL FUNDING: not reported NON‐COMMERCIAL FUNDING: not reported 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 the efficacy of small dose of insulin for progressive beta cell failure " | |
| 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 | Unblinded but there was no evidence that the analyst was blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No problems identified (typo suspected on number of patients completing trial) |
| Selective reporting (reporting bias) | Low risk | No problems identified |
| Other bias | Unclear risk | Sponsorship not reported |