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Efficacy and safety of adding evogliptin versus sitagliptin for metformin-treated patients with type 2 diabetes: A 24-week randomized, controlled trial with open label extension.

ABSTRACT: AIMS:This trial consisted of a 24-week multicentre, randomized, double-blind, double-dummy, active-controlled study and a 52-week open label extension study to assess the efficacy and safety of evogliptin, a novel dipeptidyl peptidase-4 inhibitor, compared to sitagliptin in patients with type 2 diabetes who have inadequate glycaemic control with metformin alone. METHODS:Adult patients with type 2 diabetes mellitus (N?=?222) with HbA1c 6.5% to 11% who were receiving stable doses of metformin (?1000?mg/d) were randomized 1:1 to add-on evogliptin 5?mg (N?=?112) or sitagliptin 100?mg (N?=?110) once daily for 24?weeks. The primary efficacy analysis consisted of a comparison of the change from baseline HbA1c at week 24. Non-inferiority was concluded if the upper limit of the 2-sided 95% confidence interval for the HbA1c difference between treatments was <0.35%. RESULTS:Mean changes in HbA1c following addition of evogliptin or sitagliptin were -0.59% and -0.65%, respectively. The between-group difference was 0.06% (2-sided 95% confidence interval, -0.10 to 0.22), demonstrating non-inferiority. After the 52-week treatment, evogliptin caused a persistently decreased level of HbA1c (-0.44%?±?0.65%, P ?

SUBMITTER: Hong SM

PROVIDER: S-EPMC5412933 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Efficacy and safety of adding evogliptin versus sitagliptin for metformin-treated patients with type 2 diabetes: A 24-week randomized, controlled trial with open label extension.

Hong Sang-Mo SM Park Cheol-Young CY Hwang Dong-Min DM Han Kyung Ah KA Lee Chang Beom CB Chung Choon Hee CH Yoon Kun-Ho KH Mok Ji-Oh JO Park Kyong Soo KS Park Sung-Woo SW

Diabetes, obesity & metabolism 20170222 5

<h4>Aims</h4>This trial consisted of a 24-week multicentre, randomized, double-blind, double-dummy, active-controlled study and a 52-week open label extension study to assess the efficacy and safety of evogliptin, a novel dipeptidyl peptidase-4 inhibitor, compared to sitagliptin in patients with type 2 diabetes who have inadequate glycaemic control with metformin alone.<h4>Methods</h4>Adult patients with type 2 diabetes mellitus (N = 222) with HbA1c 6.5% to 11% who were receiving stable doses of ...[more]

PMID: 28058750

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Project description:Abstract Objective To assess the safety and efficacy of Tesomet (tesofensine plus metoprolol) in adults with hypothalamic obesity, a rare disease with no approved therapy. Research Design and Methods Twenty-one adults with hypothalamic obesity (16 females, 5 males) were randomized to Tesomet (0.5 mg tesofensine/50 mg metoprolol) (n=14) or placebo (n=8) during a 24-week double-blind period. On completion of the double-blind period, 17 (81%) subjects (11 Tesomet; 6 placebo) entered in to a 24-week open-label extension period and were treated with Tesomet. The primary endpoint was safety while secondary endpoints included measures of body weight, waist circumference, and body composition. Trial NCT03845075. Results The most common adverse events following the 24-week double-blind period and the 24-week open-label extension period were sleep disorder, dizziness, dry mouth, and headache; the majority of these adverse events were mild to moderate in severity. No significant nor clinically meaningful changes in heart rate or blood pressure were observed during the study. On completion of the double-blind period mean change in body weight (kg) was -7.84 for the Tesomet group versus -0.34 kg for the placebo group (P=0. 03). At the end of the open-label extension period mean change in body weight (kg) from baseline was -6.34 for the Tesomet-Tesomet group and -6. 03 for the placebo-Tesomet group. On completion of the double-blind period mean change in waist circumference (cm) was -7. 09 cm for the Tesomet group versus -1.16 for the placebo group (P=NS). At the end of the open-label extension period mean change in waist circumference (cm) from baseline was -5.73 for the Tesomet-Tesomet group and -3. 04 for the placebo-Tesomet group. On completion of the double-blind period mean change in fat mass (kg) was -5.28 for the Tesomet group versus -1.11 for the placebo group (P=NS). At the end of the open-label extension period mean change in fat mass (kg) from baseline was -4.84 for the Tesomet-Tesomet group and -3.85 for the placebo-Tesomet group. On completion of the double-blind period mean change in lean tissue mass (kg) was -2.76 for the Tesomet group versus 0.36 for the placebo group (P<0. 01). At the end of the open-label extension period mean change in lean mass (kg) from baseline was -1.64 for the Tesomet-Tesomet group and -2.22 for the placebo-Tesomet group. Discussion Tesomet was generally well tolerated after 48 weeks treatment and resulted in clinically meaningful improvements in body weight and body composition measures in adults with hypothalamic obesity. In contrast to previous studies of tesofensine monotherapy in general obesity, no significant nor clinically meaningful changes in cardiovascular measures were observed during the study. Conclusion Tesomet is a promising new experimental treatment for hypothalamic obesity. A randomized, placebo controlled, multi-center, dose-finding, Phase 2b study has now been initiated. Presentation: No date and time listed

Project description:OBJECTIVES:The long-term safety, tolerability, and efficacy of paliperidone extended-release (ER) were evaluated in Chinese patients with schizophrenia. METHODS:Patients (aged ?18 years) with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, 4th edition criteria) who had completed run-in (8-week), stabilization (6-week), and double-blind (DB) phases (variable) of a phase-3, placebo-controlled study entered this 24-week, open-label extension (OLE) study. These patients, who had either experienced a relapse or remained relapse-free through DB phase of the study, were treated with flexible-dose paliperidone-ER (3-12 mg/day) during the OLE phase. Major safety evaluations included treatment-emergent adverse events (TEAEs) and extrapyramidal symptoms. Efficacy endpoints included changes in Positive and Negative Syndrome Scale total score, Clinical Global Impression-Severity scale, and Personal and Social Performance scale from OLE baseline to OLE endpoint. RESULTS:Out of 106 patients who entered the OLE phase (placebo: 59, paliperidone-ER: 47), a total of 85 (80%) completed it. Thirty-five (33%) patients experienced at least one TEAE; most common were akathisia, somnolence, nasopharyngitis, and constipation (3.8% each). Serious TEAEs were noted in two patients (completed suicide; schizophrenia worsening). No TEAEs with an onset during the OLE phase led to discontinuation. Extrapyramidal symptoms related-TEAEs were reported in eight (7.5%) patients. Mean (standard deviation) changes in Positive and Negative Syndrome Scale total scores (-10.4 [13.2]), Clinical Global Impression-Severity scores (-0.6 [0.96]) and Personal and Social Performance scores (7.4 [13.2]) from OLE baseline to OLE endpoint showed patients who had been treated with placebo during the DB phase experienced more pronounced improvements. CONCLUSION:In this OLE study, flexibly dosed paliperidone-ER (3-12 mg/day) was tolerable and efficacious in Chinese patients with schizophrenia.

Dataset Information

Efficacy and safety of adding evogliptin versus sitagliptin for metformin-treated patients with type 2 diabetes: A 24-week randomized, controlled trial with open label extension.

Publications

Efficacy and safety of adding evogliptin versus sitagliptin for metformin-treated patients with type 2 diabetes: A 24-week randomized, controlled trial with open label extension.

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