Use of Novel Antidiabetic Agents in Patients with Type 2 Diabetes and COVID-19: A Critical Review

Introduction. In the present meta-analysis, we aimed to determine the effects of adjuvant treatment with Chinese herbal medicine (CHM) on antidiabetic agents having additional benefits in patients with type 2 diabetes. Methods. Randomized controlled trials were identified by searching the Cochrane Library, PUBMED, EMBASE, MEDLINE, the China National Knowledge Internet, Web of Science, Global Health, International Pharmaceutical Abstracts and the China biology medicine, Wanfang, and VIP databases. The intervention group received CHM as add-on treatment to antidiabetic agents therapy, and the control group received placebos in addition to antidiabetic agents or antidiabetic agents alone. We assessed pooled data, including weighted mean differences and 95% confidence intervals (CIs) using a random-effects model. Results. A total of 125 randomized controlled trials were included. 10 articles were included based on literature screening. All trials contrasted Chinese herbal medicines or Chinese herbal medicines + antidiabetic agents with placebo or antidiabetic agents + placebo and included a total of 2004 individuals with T2DM. All selected trials displayed evidence of high methodological quality and possessed a low risk of bias. Meta-analysis of the trials demonstrated that Chinese herbal medicines resulted in a more favorable blood glucose profile in contrast to placebo (P<0.05). The total efficacy rate differed significantly between the two groups (P<0.001). All ten included studies reported the occurrence of tolerable adverse effects. Conclusions. The results showed that in the intervention group, greater reductions were achieved for glucose control and body weight. The combined use of drugs improves the curative effect and has fewer adverse events and has additional benefits in patients with type 2 diabetes. This trial is registered with PROSPERO (CRD42018093867).

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Assessing the health-related quality of life in type 2 diabetes patients treated with insulin and oral antidiabetic agents

Wiener klinische Wochenschrift ◽

10.1007/s00508-019-01573-0 ◽

2019 ◽

Cited By ~ 1

Author(s):

Nawras Al-Taie ◽

Delia Maftei ◽

Alexandra Kautzky-Willer ◽

Michael Krebs ◽

Harald Stingl

Keyword(s):

Quality Of Life ◽

Type 2 Diabetes ◽

Health Related Quality ◽

Oral Antidiabetic Agents ◽

Antidiabetic Agents ◽

Oral Antidiabetic ◽

Related Quality ◽

Health Related

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Impact of FDA-Required Cardiovascular Outcome Trials on Type 2 Diabetes Clinical Study Initiation From 2008 to 2017

Therapeutic Innovation & Regulatory Science ◽

10.1177/2168479019860122 ◽

2019 ◽

pp. 216847901986012 ◽

Cited By ~ 1

Author(s):

Cameron M. Kieffer ◽

Andrew S. Robertson

Keyword(s):

Type 2 Diabetes ◽

Private Sector ◽

Advisory Committee ◽

Committee Meeting ◽

Antidiabetic Agents ◽

Cardiovascular Outcome Trials ◽

Private Sector Investment ◽

Patient Advocates ◽

The 2008 Financial Crisis

Background: Since 2008, the US Food and Drug Administration (FDA) has required that drug manufacturers conduct postmarket cardiovascular outcomes trials (CVOTs) for approved type 2 diabetes mellitus (T2DM) drugs. The utility and impact of these studies in determining atherosclerotic cardiovascular risk was reviewed during an FDA Advisory Committee Meeting held on October 24, 2018. Drug manufacturers and patient advocates at this meeting contended that the FDA-required CVOT studies discouraged private sector investment into developing novel T2DM drugs. Here, we explore these contentions by reviewing private sector investment in T2DM drug development from 2000 through 2008, followed by a deductive analysis of how associated events—including the implementation of the CVOT requirement—may have precipitated any observed changes. Methods: We collected and analyzed industry-sponsored interventional trials for T2DM initiated between January 1, 2000, and December 31, 2017, and compared observed trends with those seen across all trials, specific diseases, and against patent filings of novel antidiabetic agents. Results: The analysis shows a marked decline in initiated T2DM clinical trials from 2008 through 2017. Possible influencing factors, including the 2008 financial crisis and a slow in the discovery of novel antidiabetic agents may have contributed, but could not fully account for this decline in T2DM studies. Conclusions: These observations are consistent with the statements made by industry representatives and patient advocates at the 2018 Advisory Committee meeting. As the FDA reconsiders postmarket requirements for T2DM products, these observations underscore the importance of considering more efficient postmarket study structures to assess cardiovascular safety beyond mandatory CVOTs.

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Efficacy of Various Antidiabetic Agents as Add-On Treatments to Metformin in Type 2 Diabetes Mellitus: Systematic Review and Meta-Analysis

ISRN Endocrinology ◽

10.5402/2012/798146 ◽

2012 ◽

Vol 2012 ◽

pp. 1-11 ◽

Cited By ~ 6

Author(s):

Nalinee Poolsup ◽

Naeti Suksomboon ◽

Wanwaree Setwiwattanakul

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Combination Therapy ◽

Meta Analysis ◽

Mean Difference ◽

Antidiabetic Agents ◽

Fasting Plasma ◽

Dpp Iv

Background and Aim. Diabetes mellitus is a chronic disease that has a great impact on patients and society. Metformin monotherapy is capable of maintaining a target glycemic control only for a short term. The aim of this study was to determine the efficacy of combination therapy of metformin with any antidiabetic agents in type 2 diabetes mellitus (T2DM) patients. Methods. Reports of randomized controlled trials (RCTs) of combination therapy of metformin with various antidiabetic agents in T2DM failing metformin alone were identified. Results. Eight studies were identified in our paper. Thiazolidinediones (TZDs) were as effective as dipeptidyl peptidase IV inhibitors (DPP IV inhs) in reducing HbA1c value (pooled mean difference −0.03%; 95% CI −0.16 to 0.10%). In comparison between TZDs and sulphonylureas (SUs), TZDs reduced fasting plasma insulin (FPI) more effectively than SUs (pool mean difference −5.72 μU/mL; 95% CI −8.21 to −3.22 μU/mL, ), but no significant differences were detected in the effects on HbA1c and fasting plasma glucose (FPG) (pooled mean difference −2.19 mg/dL; 95% CI −11.32 to 6.94 mg/dL, ). Conclusions. Our study showed that TZDs reduced FPG better than did DPP IV inhs and decreased FPI more than did SUs.

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