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Predictors and Consequences of Severe Hypoglycemia in Adults with Diabetes – Systematic Review of the Evidence Evidence-Based Synthesis Program APPENDIX E

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Predictors and Consequences of Severe Hypoglycemia in Adults with Diabetes – Systematic Review of the Evidence Evidence-Based Synthesis Program APPENDIX E Predictors and Consequences of Severe Hypoglycemia in Adults with Diabetes – Systematic Review of the Evidence Evidence-based Synthesis Program APPENDIX E. EVIDENCE TABLES Table 1. Characteristics of Included Studies Author Study Design Intervention/ Date Data Sources Control Definition of Severe Inclusion/Exclusion Criteria Patient Characteristics Study Quality Country Length of Hypoglycemia Funding Source Follow-up Target HbA1c Abraira 199530 RCT Inclusion criteria: N=153 Intensive group: Impaired consciousness Allocation Men ages 40-69, with non-insulin Age: 60.2 years stepped regimen of requiring the help Concealment: Yes United States 27 months dependent diabetes who were being % male: 100 insulin goal of HbA1c of another person, (VA Cooperative treated with insulin or judged clinically to Race/ethnicity: =5.1+/-1% or coma, or seizure; Blinding: Yes Study) require insulin because of failure of other White=49.5 confirmed low blood therapy Black=24 Standard group: one or glucose concentration Intention-to-Treat Government Exclusion criteria: Other=3 two injections of insulin/ or rapid response to Analysis (ITT): No Serious illness or predicted poor BMI: 31.0 day treatments expected to compliance, diagnosed >15 years prior Duration of diabetes: 7.8 years Goal was to avoid raise the level of blood Withdrawals/dropouts History of MI: 13.7% diabetic symptoms, glucose also required adequately described: History of CHF: 2.0% excessive glycosuria, or Yes History of CVA: 6.5% overt hypoglycemia Current smoker: 15% ACCORD 2008;3 RCT Inclusion criteria: N=10,251 Intensive group: Requiring medical Allocation Miller 2010;89 type 2 diabetes and HbA1c ≥7.5%; either Age: 62.2 years Targeted an HbA1c assistance Concealment: Yes ACCORD 20117; Mean: 40-79 years old with CV disease or 55-79 % male: 61.5 below 6.0% Bonds 200961 42 months years old with significant atherosclerosis, Race/Ethnicity (%): Requiring any Blinding: Outcomes albuminuria, LVH, or at least 2 additional White=64.5 Standard group: assistance assessment (endpoints) 2 countries, risk factors for CV disease Black=19.0 Targeted an HbA1c from 77 centers Exclusion criteria: Hispanic=7.2 7.0% to 7.9% Intention-to-Treat Frequent or recent serious hypoglycemic BMI: 32.2 Analysis (ITT): Yes Government/ events, unwillingness to do home glucose Duration of Diabetes: 10 years industry monitoring or inject insulin, BMI > 45, Cr HbA1c: 8.3% (median) Withdrawals/dropouts > 1.5 mg/dL or other serious illness adequately described: Yes ADVANCE RCT Inclusion criteria: N=11,140 Intensive glucose Blood glucose < 2.8 Allocation 20084ADVANCE Diagnosis of type 2 diabetes at 30 years Age: 66 years control:defined as mmol/L or the presence Concealment: Yes 2009 deGalan Median: 60 or older, an age of at least 55 years at % male: 57.5 the use of gliclazide of typical symptoms and ADVANCE 201090 months the time of study entry, and a history of Weight (lbs): 171.6 (modified release) signs of hypoglycemia Blinding: Outcomes 20 Countries; major macrovascular or microvascular BMI: 28 plus other drugs as without other apparent assessment disease or at least one other risk factor Type 2 (%): 100 required to achieve a cause. (endpoints) 215 centers for vascular disease Duration of diabetes: 8.0 years glycosylated Hgb value Exclusion criteria: HbA1c: 7.5% of 6.5% or less. Severe: transient Intention to Treat Government/ Definite indication for, or contraindication Aspirin: 44% dysfunction of the Analysis (ITT): Yes Industry to, any of the study treatments or a Standard glucose CNS unable to treat definite indication for long-term insulin control:(with target themselves (i.e. Withdrawals/dropouts therapy at the time of study entry glycosylated Hgb level requiring assistance adequately described: defined on the basis of from another person) Yes local guidelines 69 Predictors and Consequences of Severe Hypoglycemia in Adults with Diabetes – Systematic Review of the Evidence Evidence-based Synthesis Program Author Study Design Intervention/ Date Data Sources Control Definition of Severe Inclusion/Exclusion Criteria Patient Characteristics Study Quality Country Length of Hypoglycemia Funding Source Follow-up Target HbA1c Akram 200684 Cross-sectional Inclusion criteria: N=401 N/A Need for 3rd party Population: No survey Type 2 diabetes treated for at least one Age: 66 years assistance Denmark (response rate: year with diet or oral glucose-lowering % male: 58 Outcomes: Yes 62%) agents before commencement of insulin BMI: 29 Government therapy. Duration of diabetes: 15 years Measurement: No Questionnaire Exclusion criteria: Insulin duration: 7 years administered Patients treated with sulfonylureas, HbA1c: 8.3% Confounding: Yes at the Steno ESRD, malignant disease, pregnancy, Impaired hypoglycemic Diabetes inability to complete questionnaire awareness: 46% Intervention: N/A Center between February and May 2003 Alvarez- Cross-sectional Inclusion criteria: N=1709 N/A Needing the assistance Population: No Guisasola 200885 Type 2 diabetes, age > 30 whose Age: 62.9 years of others to manage Patient medical physicians added a SU or a TZD to % male: 54.9 Target HbA1c ≤ 6.5% symptoms or needing Outcomes: No Europe records and metformin monotherapy between Jan BMI: 31.7 medical attention Multicenter The Treatment 2001 and Jan 2006 and who had at least Duration of diabetes: 7.8 years Measurement: Yes Satisfaction one HbA1c measure in the 12-month HbA1c: 7.1% Industry Questionnaire period before the visit date Microvascular complications: Confounding: No for Medication Exclusion criteria: 2.2 Type 1 diabetes; pregnant women, Macrovascular complications: Intervention: N/A June 2006 to including those with gestational diabetes; 26.4 February 2007 patients with diabetes secondary to other factors and patients who could not complete the questionnaire or were participating in another clinical study Alvarez- Cross-sectional Inclusion criteria: N=1709 N/A Needing the assistance Population: No Guisasola 2010119 Type 2 diabetes, age > 30; physician Age: 63 years of others to manage Patient medical added a SU or a TZD to metformin % male: 55 Target HbA1c ≤ 6.5% symptoms or needing Outcomes: No Seven European records and monotherapy Jan 2001 to Jan 2006 and BMI: 31.7 medical attention Countries The Treatment who had at least one HbA1c measure in Duration of diabetes: 7.84 Measurement: Yes Satisfaction the 12-month period before the visit date Microvascular events: 2.2% Industry Questionnaire Exclusion criteria: Cardiovascular events: 26.4% Confounding: No for Medication Type 1 diabetes; pregnant women, HbA1c: 7.1% including those with gestational diabetes; Intervention: N/A 5 years patients with diabetes secondary to other factors and patients who could not complete the questionnaire or were participating in another clinical study 70 Predictors and Consequences of Severe Hypoglycemia in Adults with Diabetes – Systematic Review of the Evidence Evidence-based Synthesis Program Author Study Design Intervention/ Date Data Sources Control Definition of Severe Inclusion/Exclusion Criteria Patient Characteristics Study Quality Country Length of Hypoglycemia Funding Source Follow-up Target HbA1c Anderson 199747 RCT - Inclusion criteria: N=722 Intervention: Insulin Episode requiring Allocation crossover Type 2 diabetes, ages 35-85, on insulin Age: 59 years lispro glucagon or IV glucose Concealment: Unclear 16 countries for at least 2 months % male: 54 26 weeks Exclusion criteria: BMI: 28 Control: Blinding: No Industry Other severe disease, use of beta Duration of Diabetes: 12.4 regular insulin blockers or glucocorticoids, use of insulin years Intention-to-Treat infusion device, severe hypoglycemia Duration of insulin: 6.0 years Analysis (ITT): Yes unawareness, insulin dose > 2.0U/kg or HbA1c: 8.9% BMI > 35 Withdrawals/dropouts adequately described: No Arechavaleta RCT Inclusion criteria: N=1035 Sitagliptin + metformin Requiring non-medical Allocation concealment: 201152 Patients ≥18 years of age, with type 2 Age: 54.9 years (n=516) assistance of others, Unclear 30 weeks diabetes and with inadequate glycemic % male: 54.4 and those requiring Multinational control (defined as HbA1c ≥ 6.5% and Race/Ethnicity (%): Glimepiride + metformin medical intervention Blinding: Yes ≤9.0%) while on metformin as well as White=57.5 (n=519) or exhibiting markedly Industry diet and exercise for at least 12 weeks Asian=21.3 depressed level of Intention to treat prior to the screening visit Multiracial=14.9 consciousness or analysis (ITT): Yes Exclusion criteria: Other=5.2 seizure History of type 1 diabetes, used any Black or AA=1.2 Withdrawals/dropouts OHA besides metformin within 12 Weight (lbs): 178.9 adequately described: weeks of the screening visit, had renal BMI: 30 Yes function impairment prohibiting the use Duration of diabetes: 6.8 of metformin or had a fasting finger HbA1c: 7.5% stick glucose of <6.1 or >13.3 mmol/l at randomization Asche 200823 Retrospective Inclusion criteria: N=5438 SU: 58/2223 (2.6%) Drug-related AE defined Population: Yes cohort Patients with type 2 diabetes age >65 as being coded in United States treated with metformin, SUs or TZDs SU without insulin: the database (i.e., a Outcomes: Yes 30 weeks (never having been on any of these 55/2117 (2.6%) visit to a provider) for Industry meds before) hypoglycemia in people Measurement: Yes SU with insulin: 3/106 who had NOT had a (2.8%) similar drug-related AE Confounding: Yes metformin: 0 PRIOR to the initiation of the metformin, SU Intervention: N/A TZD: 20/889 (2.2%): or TZD TZD w/o insulin:
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