A cross-sectional study of the prevalence and clinical management of atherosclerotic cardiovascular diseases in patients with type 2 diabetes across the Middle East and Africa (PACT-MEA): Study design and rationale.

AIM: To investigate the epidemiology and clinical management of patients with type 2 diabetes (T2D) and established atherosclerotic cardiovascular disease (eASCVD) or high/very high ASCVD risk, defined by the 2021 European Society of Cardiology Guidelines, in seven countries in the Middle East and Africa (PACT-MEA; NCT05317845), and to assess physicians' attitudes and the basis for their decision-making in the management of these patients. MATERIALS AND METHODS: PACT-MEA is a cross-sectional, observational study undertaken in Bahrain, Egypt, Jordan, Kuwait, Qatar, South Africa and the United Arab Emirates based on a medical chart review of approximately 3700 patients with T2D in primary and secondary care settings, and a survey of approximately 400 physicians treating patients with T2D. RESULTS: The primary and secondary objectives are to determine the prevalence of eASCVD and high/very high ASCVD risk in patients with T2D. Current treatment with cardioprotective antidiabetic medication, the proportion of patients meeting the treatment criteria for reimbursement in the study countries where there is an applicable reimbursement guideline, and physician-reported factors in clinical decision-making in T2D management, will also be assessed. CONCLUSIONS: This large cross-sectional study will establish the estimated prevalence and management of eASCVD and high/very high ASCVD risk in patients with type 2 diabetes across the Middle East and Africa.

A Jordanian Multidisciplinary Consensus Statement on the Management of Dyslipidemia.

Atherosclerotic cardiovascular disease (ASCVD) is the primary contributor to global mortality rates, which significantly escalates healthcare expenditures. Risk factors for ASCVD (including dyslipidemia) frequently present in clusters rather than separately. Addressing these risk factors is crucial in the early initiation of a comprehensive management plan that involves both lifestyle modifications and pharmacotherapy to reduce the impact of ASCVD. A team of Jordanian professionals from various medical organizations and institutes took the initiative to create a set of guidelines for dyslipidemia screening and therapy. A detailed, comprehensive literature review was undertaken utilizing several databases and keywords. This consensus statement provides recommendations for dyslipidemia management in Jordanians on several issues including cardiovascular risk estimation, screening eligibility, risk categories, treatment goals, lifestyle changes, and statin and non-statin therapies. It is recommended that all Jordanian individuals aged 20 years old or older undergo lipid profile testing. This should be followed by determining the level of cardiovascular risk depending on the presence or absence of ASCVD and cardiovascular risk factors, eligibility for lipid-lowering therapy, and the target low-density cholesterol serum level to be achieved. In conclusion, prioritizing the management of dyslipidemia is of the utmost importance in improving public health and reducing the burden of cardiovascular diseases.

The past decade in type 2 diabetes and future challenges.

There is today an exponential increase in prevalence of type 2 diabetes mellitus (T2DM), especially in young people. This downward shift in age of onset of T2DM has been shown by abundant evidence to be due to an increase in obesity among the young, the latter mainly attributable to unhealthy dietary habits and a sedentary lifestyle. It is therefore obvious that the prevention of diabetes rather its treatment is of is paramount importance. In the past decade, because concerns about the safety of antidiabetic agents took precedence over the issue of efficacy, almost all studies have been diabetes CVOTs and not traditional CVOTs. Until 2015, the evidence showed that antidiabetic agents are effective in terms of reduction of microvascular, as opposed to macrovascular, complications. However, following publication of the results of some new studies, it became clear that the new class of antidiabetic drugs, e.g., SGLT 2 inhibitors and GLP-1 agonists, are also effective in reducing cardiovascular disease (CVD). In the coming decade, numerous health challenges are expected to arise, the most important being the greater expansion of the therapeutic armamentarium for T2DM and the adoption of strategies for prevention of CVDs. In parallel, the new generation of antidiabetic agents will target the recently investigated pathophysiologic disorders of diabetes, while, ideally, treatments should include smart drugs without side effects.

Prevalence of conventional risk factors in Jordanians with coronary heart disease: the Jordan Hyperlipidemia and Related Targets Study (JoHARTS).

BACKGROUND: The prevalence of the major conventional cardiovascular risk factors - cigarette smoking, diabetes mellitus, hypertension, and dyslipidemia - among coronary heart disease (CHD) patients in the Middle East has not been studied extensively. METHODS AND RESULTS: The Jordan Hyperlipidemia And Related Targets Study (JoHARTS) evaluated the prevalence of the 4 conventional risk factors in 5000 individuals including 1692 (34%) women. CHD was present in 1534 (31%) individuals (1202 men and 332 women). Among CHD patients, at least one risk factor was present in the majority of men (95%) and women (96%). Compared with women who had CHD, men had significantly higher prevalence of smoking (45% vs. 11%, p < 0.0001) and low levels of high-density lipoprotein cholesterol (60% vs. 39%, p < 0.0001), and lower prevalence of diabetes (40% vs. 64%, p < 0.0001), hypertension (38% vs. 63%, p < 0.0001), and hypercholesterolemia (19% vs. 27%, p = 0.003). Diabetes was more prevalent among men and women with CHD than men and women without CHD (40% vs. 18% for men, and 64% vs. 24% for women p < 0.0001). Similarly, smoking was more prevalent in men and women with CHD than those without CHD (45% vs. 32% for men, and 11% vs. 7%, p < 0.0001). Low levels of high-density lipoprotein cholesterol were also more prevalent in men with CHD than those without CHD (60% vs. 51%, p < 0.001) and among women with CHD than those without CHD (39% vs. 24%, p = 0.0001). Prevalence rates of hypertension, hypercholesterolemia, and hypertriglyceridemia were not different among individuals with or without CHD. CONCLUSION: These results further challenge claims that patients with CHD commonly lack conventional risk factors. The great majority (>95%) of CHD patients studied have at least one risk factor. Detection, evaluation and management of these factors are essential steps to control CHD in the region.

Effectiveness and tolerability of second-line treatment with vildagliptin versus other oral drugs for type 2 diabetes in a real-world setting in the Middle East: results from the EDGE study.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a chronic progressive disease that requires treatment intensification with antihyperglycemic agents due to progressive deterioration of ß-cell function. A large observational study of 45,868 patients with T2DM across 27 countries (EDGE) assessed the effectiveness and safety of vildagliptin as add-on to other oral antidiabetic drugs (OADs) versus other comparator OAD combinations. Here, we present results from the Middle East countries (Bahrain, Jordan, Kuwait, Lebanon, Oman, Palestine, and the United Arab Emirates). METHODS: Patients inadequately controlled with OAD monotherapy were eligible after the add-on treatment was chosen by the physician based on clinical judgment and patient need. Patients were assigned to either vildagliptin or comparator OADs (sulfonylureas, thiazolidinediones, glinides, α-glucosidase inhibitors, or metformin, except incretin-based therapies) based on the add-on therapy. The primary endpoint was the proportion of patients achieving a glycated hemoglobin (HbA1c) reduction of >0.3% without peripheral edema, hypoglycemia, discontinuation due to a gastrointestinal event, or weight gain≥5%. One of the secondary endpoints was the proportion of patients achieving HbA1c<7% without hypoglycemia or weight gain. Change in HbA1c from baseline to study endpoint and safety were also assessed. RESULTS: Of the 4,780 patients enrolled in the Middle East, 2,513 received vildagliptin and 2,267 received other OADs. Overall, the mean (±standard deviation) age at baseline was 52.1±10.2 years, mean HbA1c was 8.5%±1.3%, and mean T2DM duration was 4.2±4.0 years. The proportion of patients achieving the primary (76.1% versus 61.6%, P<0.0001) and secondary (54.8% versus 29.9%, P<0.0001) endpoints was higher with vildagliptin than with the comparator OADs. The unadjusted odds ratios for the primary and secondary endpoints were 1.98 (95% confidence interval 1.75-2.25) and 2.8 (95% confidence interval 2.5-3.2), respectively, in favor of vildagliptin. Vildagliptin achieved a numerically greater reduction in HbA1c (1.7%) from baseline versus comparator OADs (1.4%). The overall incidence of adverse events was comparable between studied cohorts. CONCLUSION: In real life, treatment with vildagliptin was associated with a higher proportion of patients with T2DM achieving better glycemic control without tolerability issues in the Middle East.

Achieving low-density lipoprotein cholesterol treatment goals among dyslipidemic individuals in the Levant: the CEntralized Pan-Levant survey on tHE Undertreatment of hypercholeSterolemia (CEPHEUS) study.

BACKGROUND: Several studies that evaluated achieving lipid goals have demonstrated an undertreatment of dyslipidemia. We evaluated the use and efficacy of lipid-lowering agents (LLAs) in reducing low-density lipoprotein cholesterol (LDL-C) to recommended levels in the Levant region. DESIGN AND METHODS: A multi-center, cross-sectional survey enrolled 1002 dyslipidemic patients (August 2010 - January 2011) on LLAs for ≥3 months. Collection of data and blood samples was done over one visit. Physicians and patients filled out questionnaires pertaining to dyslipidemia diagnosis and treatment. LDL-C target levels were defined according to international guidelines. RESULTS: The full analysis set included 992 patients. Mean age was 58.0 ± 11.6 years (41% women, 65.7% diabetics and 51.5% had history of coronary heart disease). LLAs were prescribed for primary prevention or secondary prevention or familial hypercholesterolemia in 45.8% and 52.8% and 1.4% of patients; respectively. Overall, 64.0% and 56.8% of the patients attained their LDL-C goal recommended by the NCEP ATP III and TJETF guidelines, respectively. According to the 2004 NCEP ATP III updated guidelines, about 24.8% of the very high risk group attained their LDL goal of ≤70 mg/dL. Smoking, diabetes, metabolic syndrome, history of cardiovascular disease, increased waist circumference, and elevated pre-treatment LDL-C level were all associated with not reaching LDL-C goals. CONCLUSIONS: Although the study cohort was a relatively high risk group and might not be representative of the general population, we found that about 60% of enrolled individuals achieved the LDL-C treatment goals and 24.8% of the very high risk group achieved the recommended LDL-C targets of ≤70 mg/dl; national strategies and aggressive awareness campaigns to effectively control lipid levels to recommended target levels, especially in the high risk groups, are urgently needed.

Insulin detemir in the management of type 2 diabetes in non-Western countries: safety and effectiveness data from the A1chieve observational study.

AIMS: This subgroup analysis of the A1chieve study examined data from 15,545 people who started treatment with insulin detemir ± oral glucose-lowering drugs in routine clinical care. METHODS: A1chieve was a 24-week, international, prospective, non-interventional study of people with type 2 diabetes from non-Western nations starting treatment with basal insulin detemir, bolus insulin aspart or biphasic insulin aspart 30, alone or in combination, to evaluate their safety and effectiveness in routine clinical practice. RESULTS: HbA1c for the global cohort improved after 24 weeks from 9.5 ± 1.6% by -2.0 ± 1.6% [80 ± 17 by -22 ± 17 mmol/mol] (-2.1 ± 1.6% [-23 ± 17 mmol/mol] for insulin-naïve participants; -1.6 ± 1.7% [-17 ± 19 mmol/mol] for prior insulin users). Fasting plasma glucose and postprandial plasma glucose were also significantly reduced (p<0.001), irrespective of prior therapy or geographical region. The incidence of major hypoglycaemia decreased significantly over 24 weeks in both the insulin-naïve and insulin-experienced groups (p<0.0001). Mean body weight decreased overall by -0.4 ± 4.0 kg and blood pressure, lipid profiles, and self-reported quality of life improved over 24 weeks for all people starting treatment with insulin detemir. CONCLUSION: People with type 2 diabetes in poor glycaemic control starting treatment with insulin detemir reported significant improvements in glycaemic control with improved treatment tolerability, irrespective of prior treatment and geographical region, after 24 weeks.

Safety and effectiveness of bolus insulin aspart in people with type 2 diabetes: a1chieve sub-analysis.

INTRODUCTION: This sub-analysis evaluated clinical safety and effectiveness of bolus insulin aspart [with/without oral glucose-lowering drugs (OGLDs)] as the only insulin therapy. METHODS: A1chieve was an international, multicenter, prospective, open-label, non-interventional, observational, 24-week study in people with type 2 diabetes mellitus starting/switching to biphasic insulin aspart 30, insulin detemir or insulin aspart treatment (alone/in combination) in routine clinical practice. This sub-analysis evaluated clinical safety and effectiveness of bolus insulin aspart (±OGLDs) as the only insulin therapy. Data were analyzed for all patients, insulin-experienced and insulin-naive sub-groups, and sub-groups defined by the number of OGLDs prescribed at baseline (no OGLDs, one OGLD or ≥two OGLDs). Safety and effectiveness endpoints were assessed at baseline and following 24 weeks' therapy. RESULTS: In total, 2,026 patients were included (insulin-experienced, n = 561; insulin-naive, n = 1,465) in this sub-analysis. Significant improvements from baseline after 24 weeks' treatment with insulin aspart ± OGLDs were observed across all sub-groups for: glycated hemoglobin (range of means across sub-groups -1.6 to -2.4%; p < 0.001 for all comparisons), fasting plasma glucose (-2.5 to -3.8 mmol/l; p < 0.001 for all comparisons), post-breakfast post-prandial glucose (-3.4 to -5.8 mmol/l; p < 0.001 for all comparisons), and health-related quality of life (HRQoL; p < 0.001 for all comparisons). The proportion of patients reporting hypoglycemia events was significantly reduced from baseline after 24 weeks (insulin-naive cohort: 7.9-2.8%; p < 0.001; insulin-experienced cohort: 23.2-7.8%; p < 0.001). There were no reports of major hypoglycemia events at 24 weeks; risk of nocturnal hypoglycemia was <0.6 events/person-year. No serious adverse drug reactions were reported. CONCLUSION: Insulin aspart ± OGLDs is associated with significant improvements in glycemic control and HRQoL, without increased risk of hypoglycemia, in people with type 2 diabetes and sub-optimal glucose control.

Safety and effectiveness of biphasic insulin aspart 30 in different age-groups: a1chieve sub-analysis.

INTRODUCTION: Effective management of type 2 diabetes requires sustained glycemic control over many years, which can be particularly challenging for elderly people. This sub-analysis of the A1chieve study evaluated the clinical safety and effectiveness of biphasic insulin aspart 30 in 3 age-groups (≤40, >40-65, and >65 years) of previously insulin-experienced and insulin-naïve people with type 2 diabetes. METHODS: A1chieve was an international, multicenter, prospective, open-label, non-interventional, 24-week study in people with type 2 diabetes who had been receiving anti-diabetes medication before starting, or switching to, therapy with biphasic insulin aspart 30, insulin detemir or insulin aspart (alone or in combination) in routine clinical practice. This sub-analysis evaluated clinical safety and effectiveness of biphasic insulin aspart 30 (±oral glucose-lowering drugs) in different age-groups. RESULTS: Data on 40,122 participants were included. In all age-groups, the proportion of participants experiencing any hypoglycemia, major hypoglycemia or nocturnal hypoglycemia was significantly reduced from baseline, except for the following in insulin-naïve patients: a significant increase in any hypoglycemia in patients aged >65 years; no change in any hypoglycemia, major hypoglycemia, and nocturnal hypoglycemia in patients aged >40-65, ≤40, and >65 years, respectively. Significant improvements at 24 weeks vs. baseline were observed in insulin-experienced and insulin-naïve participants for: glycated hemoglobin (change from baseline ranged from -1.8% to -2.4%); fasting plasma glucose (from -3.0 to -4.3 mmol/l); post-breakfast post-prandial plasma glucose (from -4.1 to -6.5 mmol/l); and health-related quality of life (HRQoL). Sixteen serious adverse drug reactions were reported. CONCLUSION: After 24-week treatment with biphasic insulin aspart 30, all age-groups of insulin-experienced and insulin-naïve patients experienced significantly improved glycemic control and HRQoL; incidence of hypoglycemia was generally reduced. The tolerability and effectiveness of biphasic insulin aspart 30 may benefit all age-groups.

Safety and Effectiveness of Switching from a Basal-only to Biphasic Insulin Aspart 30 Insulin Regimen.

PURPOSE: This sub-analysis of the A1chieve study evaluated the safety and effectiveness of changing from a basal-only insulin regimen to biphasic insulin aspart 30. METHODS: A1chieve was an international, multicenter, prospective, open-label, non-interventional, 24-week study in people with type 2 diabetes mellitus starting/switching to therapy with biphasic insulin aspart 30, insulin detemir, or insulin aspart (alone/in combination) in routine clinical practice. This sub-analysis evaluated the safety and effectiveness of switching from basal insulin with either insulin glargine (GLA group) or insulin neutral protamine Hagedorn (NEU group) to biphasic insulin aspart 30. RESULTS: A total of 2,818 participants received biphasic insulin aspart 30 (1,395 in the GLA group and 1,423 in the NEU group). After 24 weeks of treatment, there were significant reductions in the proportion of patients with at least one hypoglycemia event: total [baseline vs. 24 weeks: 15.5% vs. 9.7% (p < 0.001) and 12.3% vs. 9.9% (p < 0.05), in NEU and GLA groups, respectively], major [2.5% vs. 0.08% (p < 0.001) and 1.2% vs. 0.08% (p < 0.001), in NEU and GLA groups, respectively] and nocturnal hypoglycemia [7.2% vs. 3.5% (p < 0.001) and 5.4% vs. 3.9% (p < 0.05), in NEU and GLA groups, respectively]. After 24 weeks of biphasic insulin aspart 30 there were statistically significant improvements from baseline in glycated hemoglobin, fasting plasma glucose, and post-prandial plasma glucose levels (p < 0.001) and in health-related quality of life (p < 0.001) in both groups. CONCLUSIONS: Biphasic insulin aspart 30 may benefit patients with poor glycemic control on basal insulin regimens who are seeking to change treatment.

Comparison of National/Regional Diabetes Guidelines for the Management of Blood Glucose Control in non-Western Countries.

INTRODUCTION: Development of higher standards for diabetes care is a core element of coping with the global diabetes epidemic. Diabetes guidelines are part of the approach to raising standards. The epidemic is greatest in countries with recent rises in income from a low base. The objective of the current study was to investigate the availability and nature of locally produced diabetes guidelines in such countries. METHODS: Searches were conducted using Medline, Google, and health ministry and diabetes association websites. RESULTS: Guidelines were identified in 33 of 75 countries outside North America, western Europe, and Australasia. In 25 of these 33 countries, management strategies for type 1 diabetes were included. National guidelines relied heavily on pre-existing national and international guidelines, with reference to American Diabetes Association standards of medical care and/or other consensus statements by 55%, International Diabetes Federation by 36%, European Association for the Study of Diabetes by 12%, and American Association of Clinical Endocrinologists by 9%. The identified guidelines were generally evidence-based, though there was some use of secondary evidence reviews, including other guidelines, rather than original literature reviews and evidence synthesis. In type 1 diabetes guidelines, the option of different insulin regimens (mostly meal-time + basal or premix regimens) was recommended depending on patient need. Type 2 diabetes guidelines either recommended a glycosylated hemoglobin target of <7.0% (<53 mmol/mol) (70% of guidelines) or <6.5% (<47 mmol/mol) (30% of guidelines) as the ideal glycemic target. Most guidelines recommended a target fasting plasma glucose that fell within the range of 3.8-7.2 mmol/L. Most guidelines also set a 2-h post-prandial glucose target value within the range of 4.0-8.3 mmol/L. CONCLUSION: While only a first step in achieving a high quality of disease management, national guidelines of quality and with fair consistency of recommendations are becoming prevalent globally. A further challenge is implementation of guidelines, by integration into local care processes.

Clinical experience with insulin detemir in patients with type 2 diabetes from the near East countries.

INTRODUCTION: This study aimed at determining the clinical safety and efficacy of insulin detemir (IDet) in combination with oral anti-diabetic drugs (OADs) in type 2 diabetes (T2D) patients from four Near East Countries (Israel, Jordan, Pakistan and Lebanon). METHODS: This prospective observational study included T2D patients previously on OADs and newly diagnosed patients initiating IDet with or without OADs, at the discretion of physicians. Safety objectives included evaluation of hypoglycemia and adverse drug reactions (ADRs) from baseline to Week 24. Efficacy outcomes included baseline to Week 24 changes in glucose control parameters (glycated hemoglobin [HbA1c], fasting plasma glucose [FPG] and post-breakfast post-prandial plasma glucose [PPPG]). Change in body weight during this period was also assessed. RESULTS: A total of 2,155 patients (mean ± SD: age 57.1 ± 11.0 years, BMI 29.4 ± 5.1 kg/m(2), average diabetes duration 9.2 ± 5.4 years) were included. IDet dose at baseline was 0.20 ± 0.09 U/kg titrated up to 0.34 ± 0.14 U/kg by Week 24. From baseline to Week 24, the total number of hypoglycemic episodes increased from 1.30 to 1.37 events/patient-year, while major hypoglycemic episodes decreased from 0.15 to 0.02 events/patient-year. A total of 9 ADRs were reported, of which one event was a serious ADR. Statistically significant improvements in glucose control were reported from baseline to Week 24 (HbA1c: 9.6 ± 1.6% vs. 7.6 ± 1.1%; FPG: 201.5 ± 59.5 mg/dL vs. 124.9 ± 31.6 mg/dL; PPPG: 264.2 ± 65.7 mg/dL vs. 167.2 ± 36.8 mg/dL; all p < 0.0001). Body weight did not change significantly after 24 weeks of IDet therapy. CONCLUSION: IDet therapy in combination with OADs improved glycemic control without increasing the risk of hypoglycemia or weight gain.

Switching from biphasic human insulin 30 to biphasic insulin aspart 30 in type 2 diabetes is associated with improved glycaemic control and a positive safety profile: results from the A1chieve study.

AIMS: This A1chieve® study subgroup analysis examined clinical safety and effectiveness of biphasic insulin aspart 30 (BIAsp30) ±OGLDs in 6323 individuals with T2D, switching from biphasic human insulin 30 (BHI30) ±OGLDs. METHODS: A1chieve was a 24-week, international, prospective, observational, multi-centre, open-label study in individuals with T2D starting treatment with BIAsp30, insulin detemir or insulin aspart as part of routine clinical care. RESULTS: Mean baseline (SD) dose BHI was 0.56 (0.25) IU/kg. BIAsp30 was initiated at 0.57 (0.25) U/kg; the daily dose was 0.62 (0.28)U/kg by Week 24. Switching from BHI30 to BIAsp30 was associated with significant mean reduction in HbA1c of 1.7% [-18 mmol/mol] (1.6) from a baseline of 9.1% [76 mmol/mol] (p<0.001); FPG and PPG were also significantly reduced (p<0.001). Major hypoglycaemic episodes decreased from 0.69 events/patient/year at baseline to 0.03 events/patient/year at Week 24. Minor hypoglycaemia decreased from 5.31 to 2.04 events/patient/year from baseline to study-end. Five serious adverse drug reactions (hypoglycaemia) were reported by five individuals (0.1%). Mean bodyweight increased by 0.1 (3.3)kg from baseline to 24 weeks. Improved self-reported quality of life was observed. CONCLUSION: Switching from BHI30 to BIAsp30 in individuals with T2D is associated with improvement in glycaemic control and reduced rates of hypoglycaemia, without tolerability or safety issues.

The A1chieve study: a 60 000-person, global, prospective, observational study of basal, meal-time, and biphasic insulin analogs in daily clinical practice.

While evidenced-based guidelines promote glycated hemoglobin (HbA(1c)) targets <7.0% in order to reduce the long-term risk of diabetic complications, many individuals with type 2 diabetes do not achieve these targets. Fear of hypoglycemia provides a major barrier to improving blood glucose control as a result of delayed insulin initiation and failure to appropriately titrate insulin following initiation. Modern insulin analogs were designed to achieve improved blood glucose control with similar hypoglycemic risk compared with non-analog insulins (or similar blood glucose control with reduced hypoglycemic risk). While this has been demonstrated in randomized controlled trials, there is a need to confirm these findings in an everyday clinical setting. The A(1)chieve study will evaluate adverse events and effectiveness of premix (biphasic insulin aspart 30 [NovoMix 30]), basal (insulin detemir [Levemir]), and meal-time (insulin aspart [NovoRapid]) insulin analogs in people with type 2 diabetes in near-routine clinical practice. A(1)chieve is an international, prospective, multi-center, open-label, non-interventional, 24-week study of people with type 2 diabetes using an insulin analog. The study will recruit 60 000 people from 30 countries across four continents (Asia, Africa, South America, and Europe). The primary aim of the study is to assess the adverse event profile of the study insulins in routine clinical practice, including rates of hypoglycemia. In addition, effectiveness (HbA(1c), fasting plasma glucose, and postprandial plasma glucose) and patient quality of life outcomes will be measured. Comprehensive epidemiological data will be collected at baseline, including recent plasma glucose results and hypoglycemic episodes, prevalence of diabetes-related complications, and measures of current standards of care. Thus, A(1)chieve should provide important information about how insulin analogs perform in daily clinical practice.