A Prospective Study of Azilsartan Medoxomil in the Treatment of Patients with Essential Hypertension and Type 2 Diabetes in Asia

This phase 4 study evaluated the efficacy and safety of azilsartan medoxomil (AZL-M) in patients with essential hypertension and type 2 diabetes mellitus (T2DM) in Hong Kong, Taiwan, and Thailand. This was a prospective, multicenter, single-arm, open-label study with patients aged 18–75 years with T2DM and essential hypertension and on stable treatment for T2DM. Patients with uncontrolled hypertension were treated with AZL-M 40 mg daily, with the option to uptitrate to 80 mg at 6 weeks. In all, 380 of the 478 patients screened in Hong Kong, Taiwan, and Thailand were enrolled. At week 6, 97 patients (25.5%) were titrated up to AZL-M 80 mg based on BP readings. At 12 weeks, 54.8% of patients reached the blood pressure (BP) goal of <140/85 mm Hg by trough sitting clinic BP (primary endpoint), and 62.8% and 27.0% achieved a BP of <140/90 mm Hg and <130/80 mm Hg, respectively. The efficacy of AZL-M over 12 weeks was also seen in different age and body mass index groups. The incidence of treatment emergent adverse events (TEAEs) was 12.9% before 6 weeks and 16.1% after 6 weeks, and they were mostly mild in severity. The most frequent TEAE was dizziness (4.7%). The incidence of TEAEs leading to study drug discontinuation (4.5%) and drug-related TEAEs (5.0% before 6 weeks; 3.9% after 6 weeks) was low. In patients with essential hypertension and T2DM in Asia, treatment with AZL-M indicated a favorable efficacy and safety profile in achieving target BP.

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Efficacy and Safety of Luseogliflozin in Patients with Type 2 Diabetes Complicated by Hepatic Dysfunction: A Single-Site, Single-Arm, Open-Label, Exploratory Trial

Diabetes Therapy ◽

10.1007/s13300-021-01014-0 ◽

2021 ◽

Vol 12 (3) ◽

pp. 863-877

Author(s):

Hiroaki Seino

Keyword(s):

Type 2 Diabetes ◽

Hepatic Dysfunction ◽

Single Site ◽

Efficacy And Safety ◽

Open Label ◽

Exploratory Trial

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Efficacy and safety of liraglutide versus sitagliptin, both in combination with metformin, in Chinese patients with type 2 diabetes: a 26‐week, open‐label, randomized, active comparator clinical trial

Diabetes Obesity and Metabolism ◽

10.1111/dom.12674 ◽

2016 ◽

Vol 18 (8) ◽

pp. 803-811 ◽

Cited By ~ 14

Author(s):

L. Zang ◽

Y. Liu ◽

J. Geng ◽

Y. Luo ◽

F. Bian ◽

...

Keyword(s):

Type 2 Diabetes ◽

Clinical Trial ◽

Chinese Patients ◽

Efficacy And Safety ◽

Open Label ◽

Active Comparator

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Durable Effects of iGlarLixi Up to 52 Weeks in Type 2 Diabetes: The LixiLan-G Extension Study

10.2337/figshare.13369553 ◽

2021 ◽

Author(s):

Lawrence Blonde ◽

Julio Rosenstock ◽

Juan Frias ◽

Andreas L. Birkenfeld ◽

Elisabeth Niemoeller ◽

...

Keyword(s):

Type 2 Diabetes ◽

Fixed Ratio ◽

Efficacy And Safety ◽

Open Label ◽

Once Daily ◽

Glucagon Like Peptide ◽

Glucagon Like Peptide 1 ◽

Design And Methods ◽

Extension Period

Objective <a>In the LixiLan-G trial, switching to iGlarLixi, a once-daily titratable fixed-ratio combination of insulin glargine </a>100 units/mL and the glucagon-like peptide-1 receptor agonist (GLP-1 RA) lixisenatide, improved glucose control in type 2 diabetes (T2D) uncontrolled with GLP-1 RAs over 26 weeks versus continuing prior GLP-1 RA. A prespecified, 26-week, single-arm extension of LixiLan-G aimed to determine the durability of iGlarLixi efficacy and safety over 52 weeks. Research Design and Methods Participants with T2D uncontrolled by GLP-1 RAs (HbA1c 7–9 % [53–75 mmol/mol]) were initially randomized to switch to iGlarLixi or continue prior GLP-1 RA. Those randomized to iGlarLixi who completed the 26-week primary endpoint period could continue iGlarLixi open-label treatment over a 26-week extension to assess durability of efficacy and safety. Results Glycemic control achieved with iGlarLixi at week 26 (mean HbA1c 6.7 % [50 mmol/mol]) was maintained at week 52 (mean HbA1c 6.7 % [50 mmol/mol]; mean ± standard deviation change from baseline at week 52: −1.0 ± 0.9 % [11 ± 10 mmol/mol]). Proportions of participants reaching HbA1c <7 % (53 mmol/mol) with iGlarLixi were similar at week 26 (62%) and 52 (64%), as were those reaching this target without documented symptomatic (<3.0 mmol/L) hypoglycemia (57% and 58%). Safety of iGlarLixi was similar at weeks 26 and 52, with low rates of documented symptomatic hypoglycemia and gastrointestinal events. Conclusions The efficacy and safety of iGlarLixi at the end of the 26-week randomized treatment period was maintained over the 26-week extension period in the LixiLan-G trial.

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