Hong 2012.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
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| Participants |
Inclusion criteria: type 2 diabetes mellitus; age 30–70 years; HbA1c 7.5%–11.0%; fasting plasma glucose (FPG) < 15 mmol/L (270 mg/dL) and body mass index (BMI) 18–35 kg/m2. Female participants had to be non‐fertile or of childbearing potential using a medically approved birth control method. Exclusion criteria: type 1 diabetes, gestational diabetes or diabetes with identifiable secondary causes, significant renal impairment (estimated creatinine clearance < 50 ml/min) or elevated (> 100) alanine or aspartate aminotransferase (ALT or AST). Participants who were taking medications, aside from antidiabetic medications, known to affect glycaemic control, such as glucocorticoids were also excluded. Diagnostic criteria: not stated |
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| Interventions |
Number of study centres: 2 Treatment before study: insulin injections for at least 3 months; at a dose of at least 10 U/day and for a minimum of 4 weeks prior to enrolment. Titration period: none |
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| Outcomes |
Primary outcome(s) (as stated in the publication): change in HbA1c (from baseline to 24 weeks) Secondary outcomes (as stated in the publication): proportion of participants achieving HbA1c < 7%, body weight, waist circumference, change in insulin dose, change in C‐peptide, safety (AE, SAE, hypoglycaemia, liver/renal function) |
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| Study details |
Total study duration: 24 weeks Study terminated early (for benefit/because of adverse events): no |
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| Publication details |
Language of publication: English Funding source: non commercial; National Research Foundation Publication status: peer‐reviewed journal |
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| Stated aim of study | Quote from publication: "This study compared the efficacy and tolerability of adding sitagliptin, an oral dipeptidyl peptidase‐4 inhibitor, and an up to 20% increase in insulin dose in patients with uncontrolled type 2 diabetes on insulin therapy." | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: not mentioned in the publication |
| Allocation concealment (selection bias) | Unclear risk | Comment: not mentioned in the publication |
| Blinding of participants and personnel (performance bias) Adverse events | High risk | Comment: participants and personnel were not blinded |
| Blinding of participants and personnel (performance bias) HbA1c, FPG, lipids | High risk | Comment: participants and personnel were not blinded |
| Blinding of participants and personnel (performance bias) Insulin dose | High risk | Comment: participants and personnel were not blinded |
| Blinding of outcome assessment (detection bias) Adverse events | High risk | Comment: the outcome assessor was not blinded |
| Blinding of outcome assessment (detection bias) HbA1c, FPG, lipids | High risk | Comment: the outcome assessor was not blinded |
| Blinding of outcome assessment (detection bias) Insulin dose | High risk | Comment: the outcome assessor was not blinded |
| Incomplete outcome data (attrition bias) Adverse events | Low risk | Comment: all end points shown |
| Incomplete outcome data (attrition bias) HbA1c, FPG, lipids | Low risk | Comment: all end points shown |
| Incomplete outcome data (attrition bias) Insulin dose | Low risk | Comment: all end points shown |
| Selective reporting (reporting bias) | Low risk | Comment: none |
| Other bias | Low risk | Comment: none |