Posted by Diabetes South Texas Staff
Clinical Trial News
Monday, May 5th, 2014
Diabetes Care: April 10, 2014
OBJECTIVE To assess the long-term effects of dietary interventions on glycemic control, need for diabetes medications, and remission of type 2 diabetes.
RESEARCH DESIGN AND METHODS Originally, in a two-arm trial design, overweight, middle-aged men and women with newly diagnosed type 2 diabetes were randomized to a low-carbohydrate Mediterranean diet (LCMD; n = 108) or a low-fat diet (n = 107). After 4 years, participants who were still free of diabetes medications were further followed up until the primary end point (need of a diabetic drug); remission of diabetes (partial or complete); and changes in weight, glycemic control, and cardiovascular risk factors were also evaluated. Read More
Posted by Diabetes South Texas Staff
Clinical Trial News
Monday, May 5th, 2014
Diabetes Care: April 10, 2014
OBJECTIVE To investigate the efficacy and tolerability of empagliflozin as an add-on to metformin therapy in patients with type 2 diabetes.
RESEARCH DESIGN AND METHODS Patients with HbA1c levels of ≥7% to ≤ 10% (≥53 to ≤86 mmol/mol) while receiving metformin (≥1,500 mg/day) were randomized and treated with once-daily treatment with empagliflozin 10 mg (n = 217), empagliflozin 25 mg (n = 213), or placebo (n = 207) for 24 weeks. The primary end point was the change in HbA1c level from baseline at week 24. Key secondary end points were changes from baseline in weight and mean daily glucose (MDG) at week 24. Read More
Posted by Diabetes South Texas Staff
Clinical Trial News
Monday, May 5th, 2014
Diabetes Care: April 10, 2014
OBJECTIVE This 12-week study assessed the efficacy and tolerability of imeglimin as add-on therapy to the dipeptidyl peptidase-4 inhibitor sitagliptin in patients with type 2 diabetes that was inadequately controlled with sitagliptin monotherapy.
RESEARCH DESIGN AND METHODS In a multicenter, randomized, double-blind, placebo-controlled, parallel-group study, imeglimin (1,500 mg b.i.d.) or placebo was added to sitagliptin (100 mg q.d.) over 12 weeks in 170 patients with type 2 diabetes (mean age 56.8 years; BMI 32.2 kg/m2) that was inadequately controlled with sitagliptin alone (A1C ≥7.5%) during a 12-week run-in period. The primary efficacy end point was the change in A1C from baseline versus placebo; secondary end points included corresponding changes in fasting plasma glucose (FPG) levels, stratification by baseline A1C, and percentage of A1C responders. Read more
Posted by Diabetes South Texas Staff
Clinical Trial News
Monday, May 5th, 2014
Diabetes: April 10, 2014
Clinical responder studies should contribute to the translation of effective treatments and interventions to the clinic. Since ultimately this translation will involve regulatory approval, we recommend that clinical trials pre-specify a responder definition that can be assessed against the requirements and suggestions of regulatory agencies. In this paper we propose a clinical responder definition to specifically assist researchers and regulatory agencies interpret the clinical importance of statistically significant findings for studies of interventions intended to preserve β-cell function in newly diagnosed Type 1 diabetes. We focus on studies of six-month β-cell preservation in type I diabetes as measured by 2-hour stimulated C-peptide. We introduce criteria (bias, reliability and external validity) for the assessment of responder definitions to ensure they meet FDA and European Medicines Agency guidelines. Read More
Posted by Diabetes South Texas Staff
News
Monday, May 5th, 2014
N Engl J Med: April 17, 2014
BACKGROUND
Preventive care for adults with diabetes has improved substantially in recent decades. We examined trends in the incidence of diabetes-related complications in the United States from 1990 through 2010.
METHODS
We used data from the National Health Interview Survey, the National Hospital Discharge Survey, the U.S. Renal Data System, and the U.S. National Vital Statistics System to compare the incidences of lower-extremity amputation, end-stage renal disease, acute myocardial infarction, stroke, and death from hyperglycemic crisis between 1990 and 2010, with age standardized to the U.S. population in the year 2000. Read More
Posted by Diabetes South Texas Staff
News
Monday, May 5th, 2014
Am J Clin Nutr: June 2014
Background: Plasma phospholipid concentrations of trans-palmitoleic acid (trans-16:1n−7), a biomarker of dairy fat intake, are inversely associated with incident type 2 diabetes in 2 US cohorts.
Objective: The objective was to investigate whether the intake of trans-16:1n−7 in particular, or dairy fat in general, is associated with glucose tolerance and key factors determining glucose tolerance. Read More
Posted by Diabetes South Texas Staff
News
Monday, May 5th, 2014
Ann Intern Med.: April 15, 2014
Background: Trends in the prevalence and control of diabetes defined by hemoglobin A1c (HbA1c) levels are important for health care policy and planning.
Objective: To update trends in the prevalence of diabetes, prediabetes, and glycemic control.
Design: Cross-sectional.
Setting: NHANES (National Health and Nutrition Examination Survey) in 1988–1994 and 1999–2010.
Participants: Adults aged 20 years or older.
Measurements: We used calibrated HbA1c levels to define undiagnosed diabetes (≥6.5%); prediabetes (5.7% to 6.4%); and, among persons with diagnosed diabetes, glycemic control (<7.0% or <8.0%). Trends in HbA1c categories were compared with fasting glucose levels (≥7.0 mmol/L [≥126 mg/dL] and 5.6 to 6.9 mmol/L [100 to 125 mg/dL]). Read More
