Athena Philis-Tsimikas

Insulin Degludec Versus Insulin Glargine in Insulin-Naive Patients With Type 2 Diabetes A 1-year, randomized, treat-to-target trial (BEGIN Once Long)

OBJECTIVE To compare ultra-long-acting insulin degludec with glargine for efficacy and safety in insulin-naive patients with type 2 diabetes inadequately controlled with oral antidiabetic drugs (OADs). RESEARCH DESIGN AND METHODS In this 1-year, parallel-group, randomized, open-label, treat-to-target trial, adults with type 2 diabetes with A1C of 7−10% taking OADs were randomized 3:1 to receive once daily degludec or glargine, both with metformin. Insulin was titrated to achieve prebreakfast plasma glucose (PG) of 3.9−4.9 mmol/L. The primary end point was confirmation of noninferiority of degludec to glargine in A1C reduction after 52 weeks in an intent-to-treat analysis. RESULTS In all, 1,030 participants (mean age 59 years; baseline A1C 8.2%) were randomized (degludec 773, glargine 257). Reduction in A1C with degludec was similar (noninferior) to that with glargine (1.06 vs. 1.19%), with an estimated treatment difference of degludec to glargine of 0.09% (95% CI −0.04 to 0.22). Overall rates of confirmed hypoglycemia (PG <3.1 mmol/L or severe episodes requiring assistance) were similar, with degludec and glargine at 1.52 versus 1.85 episodes/patient-year of exposure (PYE). There were few episodes of nocturnal confirmed hypoglycemia in the overall population, and these occurred at a lower rate with degludec versus glargine (0.25 vs. 0.39 episodes/PYE; P = 0.038). Similar percentages of patients in both groups achieved A1C levels <7% without hypoglycemia. End-of-trial mean daily insulin doses were 0.59 and 0.60 units/kg for degludec and glargine, respectively. Adverse event rates were similar. CONCLUSIONS Insulins degludec and glargine administered once daily in combination with OADs provided similar long-term glycemic control in insulin-naive patients with type 2 diabetes, with lower rates of nocturnal hypoglycemia with degludec.

Predictors of glycemic control among patients with Type 2 diabetes: A longitudinal study

BackgroundDiabetes is the sixth leading cause of death and results in significant morbidity. The purpose of this study is to determine what demographic, health status, treatment, access/quality of care, and behavioral factors are associated with poor glycemic control in a Type 2 diabetic, low-income, minority, San Diego population.MethodsLongitudinal observational data was collected on patients with Type 2 diabetes from Project Dulce, a program in San Diego County designed to care for an underserved diabetic population. The study sample included 573 patients with a racial/ethnic mix of 53% Hispanic, 7% black, 18% Asian, 20% white, and 2% other. We utilized mixed effects models to determine the factors associated with poor glycemic control using hemoglobin A1C (A1C) as the outcome of interest. A multi-step model building process was used resulting in a final parsimonious model with main effects and interaction terms.ResultsPatients had a mean age of 55 years, 69% were female, the mean duration of diabetes was 7.1 years, 31% were treated with insulin, and 57% were obese. American Diabetes Association (ADA) recommendations for blood pressure and total cholesterol were met by 71% and 68%, respectively. Results of the mixed effects model showed that patients who were uninsured, had diabetes for a longer period of time, used insulin or multiple oral agents, or had high cholesterol had higher A1C values over time indicating poorer glycemic control. The younger subjects also had poorer control.ConclusionThis study provides factors that predict glycemic control in a specific low-income, multiethnic, Type 2 diabetic population. With this information, subgroups with high risk of disease morbidity were identified. Barriers that prevent these patients from meeting their goals must be explored to improve health outcomes.

A comparison of adding liraglutide versus a single daily dose of insulin aspart to insulin degludec in subjects with type 2 diabetes (BEGIN: VICTOZA ADD-ON).

Two treatment strategies were compared in patients with type 2 diabetes (T2DM) on basal insulin requiring intensification: addition of once‐daily (OD) liraglutide (Lira) or OD insulin aspart (IAsp) with largest meal.

Peer-Led Diabetes Education Programs in High-Risk Mexican Americans Improve Glycemic Control Compared With Standard Approaches: A Project Dulce promotora randomized trial

OBJECTIVE To evaluate the effect of a culturally sensitive diabetes self-management education program that uses a low-cost, peer-educator format (Project Dulce) on glucose control and metabolic parameters in low-income Mexican Americans with type 2 diabetes. RESEARCH DESIGN AND METHODS A total of 207 Mexican-American patients recruited from federally funded community health centers in San Diego County with HbA1c >8% were randomly assigned to the Project Dulce peer intervention or continuation of standard diabetes care. The primary outcome of interest was HbA1c. RESULTS The majority of subjects were born in Mexico, were female, were middle-aged, had less than an eighth-grade education, and had high baseline HbA1c levels. Significant time-by-group interaction effects for HbA1c (P = 0.02) and diastolic blood pressure (P = 0.04) indicated that the Project Dulce group exhibited greater improvement (i.e., decreases) across time. Within-group analyses showed that the intervention group exhibited significant improvements from baseline to month 4 in absolute levels of HbA1c (−1.7%, P = 0.001) and HDL cholesterol (+1.4 mg/dL, P = 0.01) and from baseline to month 10 in absolute levels of HbA1c (−1.5%, P = 0.01), total cholesterol (−7.2 mg/dL, P = 0.04), HDL cholesterol (+1.6 mg/dL, P = 0.01), and LDL cholesterol (−8.1 mg/dL, P = 0.02). No significant changes were noted in the control group. CONCLUSIONS This randomized trial, using the Project Dulce model of culturally sensitive, peer-led education, demonstrates improvement in glucose and metabolic control and suggests that this low-cost approach to self-management education for high-risk diabetic populations is effective.

Outcomes of Project Dulce: A Culturally Specific Diabetes Management Program

BACKGROUND: Diabetes mellitus is a common and costly chronic disease that increasingly affects minority populations; however, there is little evidence regarding the clinical effectiveness and costs of culturally appropriate disease management programs. OBJECTIVE: To determine the clinical outcomes and costs of Project Dulce, a combined stepped-care diabetes nurse case management program and culturally oriented peer-led self-empowerment training program. METHODS: Pre—post clinical outcome and cost analysis of Project Dulce participants were compared with a cohort of historical controls over a one-year period. Subjects included 348 persons with diabetes with coverage under County Medical Services who were receiving services in community health centers in San Diego, CA. Generalized regression models were used to estimate changes in clinical outcomes (hemoglobin [Hb] A1c, blood pressure, cholesterol level) and costs associated with participation in Project Dulce. RESULTS: Project Dulce participants had significant reductions in HbA1c (0.8%; p < 0.001), systolic (5.4 mm Hg; p = 0.001) and diastolic (8.0 mm Hg; p < 0.001) blood pressure, total cholesterol (28.1 mg/dL; p < 0.001), and low-density-lipoprotein cholesterol (15.6 mg/dL; p < 0.001). Expenditures for pharmacy (

Improved care for diabetes in underserved populations.

3157 Dulce vs

Comparison of insulin degludec with insulin glargine in insulin-naive subjects with Type 2 diabetes: a 2-year randomized, treat-to-target trial.

1618 control) and disease management (

Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 1 Diabetes: The SWITCH 1 Randomized Clinical Trial.

507 Dulce) increased. Total costs were higher during the first year of disease management (

Improving Treatment of Depression Among Latinos With Diabetes Using Project Dulce and IMPACT

5711 Dulce vs

Type 2 diabetes care and insulin intensification: is a more multidisciplinary approach needed? Results from the MODIFY survey.

4365 control; p < 0.001). CONCLUSIONS: Project Dulce was effective in improving clinical outcomes for control of diabetes and related conditions in a medically indigent, culturally diverse population. Our finding of reduced hospital expenditures, although statistically insignificant, is clinically and economically important and suggests that intervention might provide an immediate benefit to a high-risk population.