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American Diabetes Journals 10/28/2019 11:21
OBJECTIVE. The purpose of this study was to determine if the International Hypoglycemia Study Group (IHSG) level 2 low glucose definition could identify clinically relevant hypoglycemia in clinical trials and offer value as an end point for future trials. RESEARCH DESIGN AND METHODS. A post hoc analysis of the SWITCH (SWITCH 1: n = 501, type 1 diabetes; SWITCH 2: n = 721, type 2 diabetes) and the Trial Comparing Cardiovascular Safety of Insulin Degludec versus Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE; n = 7,637, type 2 diabetes) using the IHSG low glucose definitions.
American Diabetes Journals 10/21/2019 15:00
The SEARCH for Diabetes in Youth (SEARCH) study found cardiac autonomic dysfunction in 17% of their cohort of young adults with youth-onset T2D (compared with a lean control group), a higher prevalence than that seen in young adults with type 1 diabetes (17% vs. 12%) (17 ...
American Diabetes Journals 10/21/2019 15:00
OBJECTIVE. Fixed-ratio combinations of basal insulin plus glucagon-like peptide 1 receptor agonist (GLP-1 RA) allow concomitant administration of two proven complementary injectable therapies for type 2 diabetes. This study investigated switching to a titratable fixed-ratio combination of insulin glargine plus lixisenatide (iGlarLixi) in patients with type 2 diabetes receiving daily or weekly GLP-1 RA therapy. RESEARCH DESIGN AND METHODS. LixiLan-G, a randomized, open-label, 26-week trial, compared switching to iGlarLixi versus continuing prior GLP-1 RA in patients with type 2 diabetes and HbA 1c 7–9% (53–75 mmol/mol) taking maximum tolerated doses of a GLP-1 RA daily (60% on liraglutide once daily or exenatide twice daily) or weekly (40% on
American Diabetes Journals 09/20/2019 15:00
The parallelism between the rise in leukocyte and retinal superoxide in diabetic mice and the fall in leukocyte and retinal superoxide levels in montelukast-treated diabetic mice poses the potential use of leukocyte superoxide generation as a biomarker, and perhaps surrogate outcome, for monitoring diabetic retinopathy in clinical trials and, ultimately, in clinical practice ...
American Diabetes Journals 09/20/2019 15:00
In previous trials involving participants with type 2 diabetes, hematocrit increased by 3–7% relative to baseline values and remained elevated over the course of long-term clinical trials (38,39), likely due to hemoconcentration (13) or, alternatively, secondary to increased erythropoietin production (40 ...
American Diabetes Journals 09/20/2019 15:00
Similar findings from the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) clinical trial showed rapid development of albuminuria, hypertension, hyperlipidemia (12), and arterial stiffness (13) among youth with T2D enrolled at a mean age of 20.8 years and a mean diabetes duration of only 7.6 years, similar ...
American Diabetes Journals 08/20/2019 15:00
OBJECTIVE. This trial compared the efficacy and safety of the first oral glucagon-like peptide 1 (GLP-1) receptor agonist, oral semaglutide, as monotherapy with placebo in patients with type 2 diabetes managed by diet and exercise alone. Two estimands addressed two efficacy-related questions: a treatment policy estimand (regardless of trial product discontinuation or rescue medication use) and a trial product estimand (on trial product without rescue medication use) in all randomized patients. RESEARCH DESIGN AND METHODS. This was a 26-week, phase 3a, randomized, double-blind, placebo-controlled, parallel-group trial conducted in 93 sites in nine countries. Adults with type 2 diabetes insufficiently controlled with diet and exercise were rand.
American Diabetes Journals 08/20/2019 15:00
OBJECTIVE. The Follow-Up Study of patients previously enrolled in Exubera controlled clinical trials (FUSE) was designed to evaluate whether patients previously treated with Exubera (EXU; insulin human [rDNA origin], inhaled powder) in controlled clinical trials died because of incident primary lung cancer at a substantially higher rate than patients treated with a comparator. RESEARCH DESIGN AND METHODS. FUSE is a hybrid, randomized, controlled trial/cohort study including participants of 17 prior EXU clinical trials.

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