Kobayashi 1996.
| Methods |
RANDOMISED CONTROLLED CLINICAL TRIAL (RCT): yes, parallel RCT RANDOMISATION RATIO: equal ratio NON‐INFERIORITY DESIGN: no EQUIVALENCE DESIGN: no ETHICS APPROVAL OBTAINED: unclear PATIENT CONSENT OBTAINED: yes BLINDING OF PATIENT (P), EDUCATOR (E), RESEARCHER (R): P = no, E = no, R = unclear ANALYSIS BY INTENTION TO TREAT: no (not stated in manuscript) POWER CALCULATION: no |
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| Participants |
WHO PARTCIPATED: SEX (female% / male%): Insulin 30%F (2/5): 60% M (3/5), SU 30% F (2/5) : 60% M(3/5) AGE (mean years (SD)): Insulin: 51 years (8), SU 48 yrs (11) ETHNIC GROUPS (%): not stated DURATION OF DISEASE (mean years (SD)): insulin 0.7 yrs (1.1), SU 1.5 yrs (2.1) INCLUSION CRITERIA: (1) disease diagnosed according to the National Diabetes Data Group (2) ICA positive (3) patients were not related to each other EXCLUSION CRITERIA: (1) history of ketonuria, diabetic ketoacidosis or marked hypoglycaemia initially requiring insulin DIAGNOSTIC CRITERIA: Type 2 diabetes newly diagnosed by general practitioner and fasting plasma glucose higher than 6.0 mmol/L on two subsequent occasions. CO‐MORBIDITIES:Not given CO‐MEDICATIONS: Not given NUMBER: Insulin 5, SU 5. LOSS TO FOLLOW‐UP: 0% |
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| Interventions |
NUMBER OF STUDY CENTRES:not given COUNTRY/ LOCATION: Japan SETTING: out‐patient INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY): small doses of sub‐cutaneous insulin CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY): sulphonylurea (glibenclamide) TREATMENT BEFORE STUDY:Diet therapy before study entry. Consume a diet containing 30 kcal per kg ideal body weight per day with 55%‐60% carbohydrate. TITRATION PERIOD:None |
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| Outcomes |
PRIMARY OUTCOME(S) (as stated in the publication): Not stated but objectives states "effects of small doses of insulin in patients with NIDDM who were ICA positive" SECONDARY OUTCOMES (as stated in the publication):Not stated ADDITIONAL OUTCOMES: Collected at baseline and 30 months. 1. HbA1c (%), 2. Fasting blood glucose (mmol/L) 3. Change in serum C‐peptide to OGTT 4.. 2‐hr blood glucose (mmol/L), 5. BMI (kg/m2), 5. Insulin dose (U/day), 6. ICA titre. |
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| Study details |
DURATION OF INTERVENTION: 30 months DURATION OF FOLLOW‐UP: 30 months RUN‐IN PERIOD: Not given |
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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 " conduct a prospective pilot study on the effects of small doses of insulin in patients with presumed NIDDM who were ICA and thus at high risk for progression to insulin dependence" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not given in manuscript |
| 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 |
| Selective reporting (reporting bias) | Low risk | No problems identified |
| Other bias | Low risk | No problems identified |