Cabrera‐Rode 2002.
| 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: unclear (not stated) PATIENT CONSENT OBTAINED: yes BLINDING OF PATIENT (P), EDUCATOR (E), RESEARCHER (R): P = no, E = no, R = no ANALYSIS BY INTENTION TO TREAT: not stated. No loss to follow‐up POWER CALCULATION: no |
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| Participants |
WHO PARTCIPATED: SEX (female% / male%): Insulin+SU: 66%F(4/6): .33% M (2/6). Insulin: 38%F (3/8): 62%M (5/8) AGE (mean years (SD)): Insulin+SU: 53.5 (16.9), Insulin: 53.0 (6.4) ETHNIC GROUPS (%): not specified DURATION OF DISEASE (mean years (SD)):Insulin + SU: 1.5 yrs (1.8), Insulin: 2.0 yrs (2.6) INCLUSION CRITERIA: Type 2 diabetic patients with ICA (>20 JDF U) and GADA65A (on at least two consecutive tests) previously treated with glibenclamide and insulin (for at least 1 month) without history of ketonuria and diabetic ketoacidosis. EXCLUSION CRITERIA: not specified DIAGNOSTIC CRITERIA: Diagnosed with type 2 diabetes with ICA and GADA CO‐MORBIDITIES:Not given CO‐MEDICATIONS: Not given NUMBER: Insulin + SU: 6, Insulin: 8 LOSS TO FOLLOW‐UP: 0% |
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| Interventions |
NUMBER OF STUDY CENTRES: not given COUNTRY/ LOCATION: Cuba SETTING: out patient INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY): insulin therapy CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY): insulin therapy plus sulphonylurea (glibenclamide) TREATMENT BEFORE STUDY: Previously treated with glibenclamide and insulin (for at least 1 month) TITRATION PERIOD: Not given |
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| Outcomes |
PRIMARY OUTCOME(S) (as stated in the publication): Not stated but objectives states "evaluate if exclusion of glibenclamide may diminish levels of ICA and anti GADA65 antibodies" SECONDARY OUTCOMES (as stated in the publication):Not stated but objectives states "evaluate if exclusion of glibenclamide may improve fasting glucose and insulin secretion". ADDITIONAL OUTCOMES: Collected at baseline and 12 months : 1. Fasting blood glucose (mmol/L), 2. Fasting C‐peptide (pmol/L), 3. BMI (kg/m2), 4. Insulin dose (U/day), 5. SU (glibenclamide, mg/day) |
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| Study details |
DURATION OF INTERVENTION: 12 months DURATION OF FOLLOW‐UP: 12 months RUN‐IN PERIOD: Treatment with glibenclamide and insulin for at least 1 month |
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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 evaluate whether the exclusion of glibenclamide in the treatment of ICA positive type 2 diabetic patients may diminish the levels of ICA and anti‐GAD65 autoantibodies as well as improve fasting glucose and insulin secretion " | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No description given |
| Allocation concealment (selection bias) | Low risk | Unblinded |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Unblinded trial but there was no evidence that the analyst was blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No participants lost to follow‐up |
| Selective reporting (reporting bias) | Low risk | HbA1c was not reported however FBG was reported |
| Other bias | Low risk | No problem identified |