Posted by Staff
Clinical Trial News, Clinical Trials
Monday, May 5th, 2014
The Lancet Diabetes & Endocrinology: April 4, 2014
Background
When patients with type 2 diabetes start their first injectable therapy, clinicians can choose between glucagon-like peptide-1 (GLP-1) receptor agonists and basal insulins. In DURATION-3, exenatide once weekly was compared with insulin glargine (henceforth, glargine) as first injectable therapy. Here, we report the results of the final 3-year follow-up.
Methods
DURATION-3 was an open-label randomised trial done between May 13, 2008, and Jan 30, 2012. Patients with type 2 diabetes aged 18 years or older were enrolled at 72 sites worldwide. They were eligible when they had suboptimum glycaemic control (HbA1c 7·1—11·0% [54—97 mmol/mol]) despite maximum tolerated doses of metformin alone or with a sulfonylurea for at least 3 months, a stable bodyweight for at least 3 months, and a BMI of 25—45 kg/m2 (23—45 kg/m2in South Korea and Taiwan). Patients were randomly assigned (1:1) by computer-generated random sequence with an interactive voice-response system (block size four, stratified by country and concomitant therapy) to once-weekly exenatide (2 mg subcutaneous injection) or once-daily glargine (titrated to target) to be given in addition to their existing oral glucose-lowering regimens.
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Posted by Staff
Clinical Trials
Monday, May 5th, 2014
Diabetes Care: April 4, 2014
OBJECTIVE Plasma adiponectin levels are reduced in type 2 diabetes mellitus (T2DM) and other insulin-resistant states. We examined whether plasma adiponectin levels at baseline and after pioglitazone treatment in impaired glucose tolerance (IGT) subjects were associated with improved insulin sensitivity (SI) and glucose tolerance status.
RESEARCH DESIGN AND METHODS A total of 602 high-risk IGT subjects in ACT NOW were randomized to receive pioglitazone or placebo with a median follow-up of 2.4 years.
RESULTS Pioglitazone reduced IGT conversion to diabetes by 72% in association with improved β-cell function by 64% (insulin secretion/insulin resistance index) and increased tissue sensitivity by 88% (Matsuda index).Read More
Posted by Staff
Clinical Trials
Monday, May 5th, 2014
Am J Clin Nutr: June 2014
Background: The results of human clinical trials investigating the effects of resveratrol on glucose control and insulin sensitivity are inconsistent.
Objective: We aimed to quantitatively evaluate the effects of resveratrol on glucose control and insulin sensitivity.
Design: We performed a strategic literature search of PubMed, Embase, MEDLINE, and the Cochrane Library (updated to March 2014) for randomized controlled trials that estimated the effects of resveratrol on glucose control and insulin sensitivity. Study quality was assessed by using the Jadad scale. Weighted mean differences were calculated for net changes in glycemic measures by using fixed-effects or random-effects models. We performed prespecified subgroup and sensitivity analyses to evaluate potential heterogeneity. Meta-regression analyses were conducted to investigate dose effects of resveratrol on fasting glucose and insulin concentrations in nondiabetic subjects. Read more
Posted by Staff
Clinical Trials
Monday, May 5th, 2014
Diabetes: April 2, 2014
The potential influence of gastric emptying on the ‘incretin effect’, mediated by glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1), is unknown. The objectives of this study were to determine the effects of intraduodenal glucose infusions at 2 (ID2) and 4 (ID4) kcal/min (equating to two rates of gastric emptying within the physiological range) on the size of the incretin effect, gastrointestinal glucose disposal and plasma GIP, GLP-1 and glucagon, in health and type 2 diabetes. We studied 10 male BMI-matched controls and 11 male type 2 patients, managed by diet or metformin only. In both groups, GIP, GLP-1 and the magnitude of incretin effect were greater with ID4 than ID2, as was gastrointestinal glucose disposal; plasma glucagon was suppressed by ID2, but not ID4. Read More
Posted by Staff
Clinical Trials
Monday, May 5th, 2014
The Lancet Diabetes & Endocrinology: March 5, 2014
Background
Reduction of dietary sodium intake or diuretic treatment increases renin-angiotensin-aldosterone system (RAAS) blockade efficacy in non-diabetic nephropathy. We aimed to investigate the effect of sodium restriction and the diuretic hydrochlorothiazide, separately and in combination, added to RAAS blockade on residual albuminuria in patients with type 2 diabetic nephropathy.
Methods
In this multicentre, double-blind, placebo-controlled, crossover randomised trial, we included patients with type 2 diabetic nephropathy. Main entry criteria were microalbuminaria or macroalbuminuria, and creatinine clearance of 30 mL/min or higher with less than 6 mL/min decline in the previous year.
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Posted by Diabetes South Texas Staff
Minority Diabetes Reports
Monday, May 5th, 2014
Diabetes Care: April 10, 2014
OBJECTIVE To compare a peer leader (PL) versus a community health worker (CHW) telephone outreach intervention in sustaining improvements in HbA1cover 12 months after a 6-month diabetes self-management education (DSME) program.
RESEARCH DESIGN AND METHODS One hundred and sixteen Latino adults with type 2 diabetes were recruited from a federally qualified health center and randomized to 1) a 6-month DSME program followed by 12 months of weekly group sessions delivered by PLs with telephone outreach to those unable to attend or 2) a 6-month DSME program followed by 12 months of monthly telephone outreach delivered by CHWs. The primary outcome was HbA1c. Secondary outcomes were cardiovascular disease risk factors, diabetes distress, and diabetes social support. Assessments were conducted at baseline, 6, 12, and 18 months. Read More
Posted by Diabetes South Texas Staff
Clinical Trial News
Monday, May 5th, 2014
Diabetologia/Springer Link: May 2014
Aims/hypothesis
The cholesterol absorption inhibitor ezetimibe has been shown to ameliorate non-alcoholic fatty liver disease (NAFLD) pathology in a single-armed clinical study and in experimental animal models. In this study, we investigated the efficacy of ezetimibe on NAFLD pathology in an open-label randomised controlled clinical trial.
Methods
We had planned to enrol 80 patients in the trial, as we had estimated that, with this sample size, the study would have 90% power. The study intervention and enrolment were discontinued because of the higher proportion of adverse events (significant elevation in HbA1c) in the ezetimibe group than in the control group. Thirty-two patients with NAFLD were enrolled and randomised (allocation by computer program). Ezetimibe (10 mg/day) was given to 17 patients with NAFLD for 6 months. The primary endpoint was change in serum aminotransferase level. Read More
