Kitabchi 1987.
| Methods |
Cross‐over randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
|
| Participants |
Inclusion criteria: obese (130%‐200% IBW) women with type 2 diabetes mellitus on prior insulin therapy who were poorly controlled but without severe diabetic complications. Exclusion criteria: history of diabetic ketoacidosis Diagnostic criteria: not stated |
|
| Interventions |
Number of study centres: 1 Treatment before study: insulin 0.89 ± 0.07 U/kg/BW Titration period: none |
|
| Outcomes | Primary outcome(s) (as stated in the publication): glycaemic control (HbA1c, FBG, 2‐hour post prandial glucose), bodyweight, insulin requirement, total cholesterol, triglyceride, C‐peptide | |
| Study details |
Total study duration: 6 months Run‐in period: no Study terminated early (for benefit/because of adverse events): no |
|
| Publication details |
Language of publication: English Funding source: NIH, Abe Goodman Fund for Diabetes Research, Eli Lilly, Upjohn Company Publication status: peer‐reviewed journal |
|
| Stated aim of study | Quote from publication: "To assess the efficacy of combined NPH and tolazamide in enhancing insulin secretion and tissue sensitivity in obese patients with type 2 diabetes mellitus who were maintained at the same weight and glycaemic index during both phases of the study." | |
| Notes | Several young participants with long‐term insulin use and without severe obesity | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: not possible to judge whether the sequence generation was adequate |
| Allocation concealment (selection bias) | Unclear risk | Comment: not possible to judge whether the allocation to the intervention and control group was concealed |
| Blinding of participants and personnel (performance bias) Adverse events | Unclear risk |
Quote from publication: "In a randomised cross‐over trial, ..." Comment: unclear if it was a blinded trial |
| Blinding of participants and personnel (performance bias) HbA1c, FPG, lipids | Unclear risk |
Quote from publication: "In a randomised cross‐over trial, ..." Comment: unclear if it was a blinded trial |
| Blinding of participants and personnel (performance bias) Insulin dose | Unclear risk |
Quote from publication: "In a randomised cross‐over trial, ..." Comment:unclear if it was a blinded trial |
| Blinding of outcome assessment (detection bias) Adverse events | Unclear risk |
Quote from publication: "In a randomised cross‐over trial, ..." Comment: unclear if it was a blinded trial |
| Blinding of outcome assessment (detection bias) HbA1c, FPG, lipids | Unclear risk |
Quote from publication: "In a randomised cross‐over trial, ..." Comment: unclear if it was a blinded trial |
| Blinding of outcome assessment (detection bias) Insulin dose | Unclear risk |
Quote from publication: "In a randomised cross‐over trial, ..." Comment: unclear if it was a blinded trial |
| Incomplete outcome data (attrition bias) Adverse events | Low risk | Comment: data on weight gain were reported |
| Incomplete outcome data (attrition bias) HbA1c, FPG, lipids | Low risk | Comment: outcome data were collected and reported |
| Incomplete outcome data (attrition bias) Insulin dose | Low risk | Comment: data on insulin dose were reported |
| Selective reporting (reporting bias) | Low risk | Comment: outcomes of interest were reported |
| Other bias | Unclear risk | Comment: funded by a pharmaceutical company |