Characteristics of included studies
| Study/trial or database | Study population | Insulin exposures | Patients (n) | Study period (mean follow-up (months)) | Potential confounders adjusted for in full adjusted model | Funding source; country |
|---|---|---|---|---|---|---|
| Randomised clinical trials | ||||||
| Raz et al14 (HEART2D) | Patients with T2DM+recent MI | Insulin lispro | 557 | 2002–2005 (32) | Not applicable | Industry; Austria, Czech Republic, Israel, Poland, USA |
| NPH insulin or insulin glargine | 558 | |||||
| UGDP15 | Incident T2DM | Fixed: U-80 Lente Iletin insulin (10, 12, 14 or 16 U/day) | 210 | 1961–1975 (150) | Not applicable | Industry, Government; USA |
| Variable: U-80 Lente Iletin insulin or other insulins, as much as required to maintain ‘normal’ glucose control (minimum 5 U/day) | 204 | |||||
| Cohort studies | ||||||
| Gamble et al16 (Saskatchewan Health) | New users of insulin | Low exposure: <3 rx’s/year | 1443 | 1991–1996 (61) | Age, sex, CDS, DM severity, OAD, CV rx’s, hospitalised 1 year prior to insulin exposure | Government; Canada |
| Moderate exposure: 3<12 rx’s/year (<1 vial/month) | ||||||
| High exposure: ≥12 rx’s/year (<1 vial/month) | ||||||
| Hall et al17 (The Health Information Network) | New users of insulin | Premixed insulin (after 2 or 3 baseline OADs) | 1399 | 2000–2008 (43) | Age, sex, DM duration, OAD, CV rx’s, year, HbA1c, cholesterol, BMI, smoking status, eGFR, history of vascular disease, microalbuminuria | Industry; UK |
| NPH insulin (after 2 or 3 baseline OADs) | 601 | |||||
| Basal insulin (after 2 or 3 baseline OADs) | 1427 | |||||
| Juhaeri et al18 (PharMetrics) | T2DM and new users of insulin | Insulin glargine monotherapy | 11 534 | 2001–2007 (NR) | Age, sex, history of hypertension, history of dislipidaemia, days of supply, duration of diabetes | Industry; USA |
| Insulin glargine+other insulins | 16 540 | |||||
| Other insulin regimen (lispro, aspart, regular, premixed or mixed) | 30 979 | |||||
| Long-acting/intermediate-acting insulin (ultralente, NPH, lente) | 6566 | |||||
| Kress et al19 (IMS Disease Analyzer) | T2DM and new users of insulin glulisine and regular insulin | Insulin glulisine | 952 | 2004–2010 (42) | Age, sex, geography, CCS, co-rx’s, diabetologist, insurance type, OADs, co-rx with insulin, previous rx for regular insulin, microvascular dz, CC, HbA1c | Industry; Germany |
| Regular human insulin | 11 157 | |||||
| Rathmann and Kostev20 (IMS Disease Analyzer) | New users of insulin aspart and regular insulin | Insulin aspart (rapid-acting) | 3154 | 2000–2011 (42) | Age, sex, geography, CCS, co-rx’s, diabetologist, insurance type, CC, co-rx with insulin, previous rx for regular insulin, OADs, microvascular/macrovascular dz, hypoglycaemia | Industry; Germany |
| Regular human insulin (short-acting) | 3154 | |||||
| Rhoads et al21 (IMS Disease Analyzer) | T2DM and new users of insulin glargine and NPH insulin | Insulin glargine | 14 730 | 2001–2005 (24) | Age, year, CCS, co-rx’s, OAD, CC, healthcare resource use, endocrinologist, inpatient vs outpatient insulin initiation, MPR, insurance type, co-pay level, geography, hypoglycaemia, HbA1c | Industry; USA |
| NPH insulin | 5461 | |||||
BMI, body mass index; CC, comorbid conditions; CCS, Charlson comorbidty score; CDS, chronic disease score; CV, cardiovascular; DM, diabetes mellitus; dz, disease; eGFR, estimated glomerular filtration rate; HbA1c, glycated haemoglobin; HEART2D, Hyperglycaemia and Its Effects After Acute Myocardial Infarction on Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus; MI, myocardial infarction; MPR, medication possession ratio; NPH, neutral protamine hagedorn; NR, not reported; OAD, oral antidiabetic drug; rx, prescription record; T2DM, type 2 DM; UGDP, University Group Diabetes Program.