Real-world Efficacy and Safety of Dulaglutide in Korean Patients with Type 2 Diabetes Mellitus: A Retrospective Study in a Tertiary Referral Center

Abstract Background: This study was conducted to evaluate the efficacy and safety of once-weekly dulaglutide therapy as add-on to oral antidiabetic drugs (OADs) and basal insulin in Korean patients with type 2 diabetes mellitus (T2DM) in the real-world clinical practice.Methods: We retrospectively reviewed the medical records of 112 patients who received dulaglutide in a tertiary referral center. The primary efficacy endpoint was a change in glycated hemoglobin (HbA1c) between baseline and 6 months. The secondary endpoints were the percentage of patients achieving HbA1c <7.0% or ≤6.5% and the change of body weight at 6 months. Results: At baseline, the mean HbA1c was 8.7 % (8.8% in the add-on to OAD and 8.5% in the add-on to insulin group). The mean adjusted HbA1c at 6 months decreased by −1.13% in the overall patients (p < 0.001), and by −1.36 and −0.74% in the add-on to OAD and add-on to insulin group, respectively. A significant reduction of −2.9 kg in body weight was observed in the overall patients at 6 months (p < 0.001). Approximately 34.8% and 23.2% of patients achieved HbA1c <7.0% and ≤6.5%, respectively. Higher baseline HbA1c and no previous insulin therapy were associated with good response to dulaglutide on multivariate analysis. In subgroup analysis to evaluate the long-term efficacy of dulaglutide (n=82), the mean adjusted HbA1c decreased by −0.86% from baseline to 12 months (p < 0.001). Mild gastrointestinal issues (23.2%) were the most frequently observed adverse events.Conclusions: Dulaglutide is an effective and durable treatment option as add-on to OAD and basal insulin therapy in Korean patients with T2DM.

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Real-World Efficacy and Safety of Dulaglutide in Korean Patients with Type 2 Diabetes Mellitus: A Retrospective Study in a Tertiary Referral Center

Chonnam Medical Journal ◽

10.4068/cmj.2021.57.3.211 ◽

2021 ◽

Vol 57 (3) ◽

pp. 211

Author(s):

Jee Hee Yoon ◽

A Ram Hong ◽

Wonsuk Choi ◽

Ji Yong Park ◽

Hee Kyung Kim ◽

...

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Retrospective Study ◽

Real World ◽

Efficacy And Safety ◽

Tertiary Referral ◽

Tertiary Referral Center ◽

Referral Center

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Efficacy and Safety of Ertugliflozin in Patients With Type 2 Diabetes Mellitus and Established Cardiovascular Disease Treated With Metformin and Sulfonylurea

Journal of the Endocrine Society ◽

10.1210/jendso/bvab048.676 ◽

2021 ◽

Vol 5 (Supplement_1) ◽

pp. A331-A331

Author(s):

Matthew J Budoff ◽

Timothy M E Davis ◽

Alexandra G Palmer ◽

Robert Frederich ◽

David E Lawrence ◽

...

Keyword(s):

Diabetes Mellitus ◽

Blood Pressure ◽

Type 2 Diabetes ◽

Cardiovascular Disease ◽

Type 2 Diabetes Mellitus ◽

Body Weight ◽

Glycemic Control ◽

Sglt2 Inhibitor ◽

Efficacy And Safety

Abstract Introduction: Ertugliflozin (ERTU), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, is approved as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus (T2DM). Aim: As a pre-specified sub-study of the Phase 3 VERTIS CV trial (NCT01986881), the efficacy and safety of ERTU were assessed in patients with T2DM and established atherosclerotic cardiovascular disease (ASCVD) inadequately controlled with metformin and sulfonylurea (SU). Methods: Patients with T2DM, established ASCVD, and HbA1c 7.0–10.5% on stable metformin (≥1500 mg/day) and SU doses as defined per protocol were randomized to once-daily ERTU (5 mg or 15 mg) or placebo. The primary sub-study objectives were to assess the effect of ERTU on HbA1c compared with placebo and to evaluate safety and tolerability during 18-week follow-up. Key secondary endpoints included proportion of patients achieving HbA1c <7%, fasting plasma glucose (FPG), body weight, and systolic blood pressure. Changes from baseline at Week 18 for continuous efficacy endpoints were assessed using a constrained longitudinal data analysis model. Results: Of the 8246 patients enrolled in the VERTIS CV trial, 330 patients were eligible for this sub-study (ERTU 5 mg, n=100; ERTU 15 mg, n=113; placebo, n=117). Patients had a mean (SD) age of 63.2 (8.4) years, T2DM duration 11.4 (7.4) years, estimated glomerular filtration rate 83.5 (17.8) mL/min/1.73 m2, and HbA1c 8.3% (1.0) (67.4 [10.6] mmol/mol). At Week 18, ERTU 5 mg and 15 mg were each associated with a significantly greater least squares mean (95% CI) HbA1c reduction from baseline versus placebo; the placebo-adjusted differences for ERTU 5 mg and 15 mg were –0.7% (–0.9, –0.4) and –0.8% (–1.0, –0.5), respectively (P<0.001). A higher proportion of patients in each ERTU group achieved HbA1c <7% relative to placebo (P<0.001). ERTU significantly reduced FPG and body weight (P<0.001, for each dose versus placebo), but not systolic blood pressure. Adverse events were reported in 48.0%, 54.9%, and 47.0% of patients in the ERTU 5 mg, 15 mg, and placebo groups, respectively. Genital mycotic infections were experienced by significantly higher proportions of male patients who received ERTU 5 mg and 15 mg (4.2% and 4.8%, respectively) versus placebo (0.0%; P≤0.05) and by a numerically, but not significantly, higher proportion of female patients who received ERTU 15 mg (10.3%) compared with placebo (3.8%) (P=0.36). The incidences of symptomatic hypoglycemia were 11.0% (5 mg), 12.4% (15 mg), and 7.7% (placebo), and of severe hypoglycemia 2.0% (5 mg), 1.8% (15 mg), and 0.9% (placebo). Conclusion: Among patients with T2DM and ASCVD, ERTU (5 mg and 15 mg) added to metformin and SU for 18 weeks improved glycemic control (HbA1c and FPG) and reduced body weight, and was generally well tolerated with a safety profile consistent with the SGLT2 inhibitor class.

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Liraglutide: A Once-Daily Incretin Mimetic for the Treatment of Type 2 Diabetes Mellitus

Annals of Pharmacotherapy ◽

10.1345/aph.1m134 ◽

2009 ◽

Vol 43 (9) ◽

pp. 1433-1444 ◽

Cited By ~ 42

Author(s):

Joshua J Neumiller ◽

R Keith Campbell

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Body Weight ◽

Efficacy And Safety ◽

Β Cell ◽

Once Daily ◽

Glucagon Like Peptide ◽

Glucagon Like Peptide 1

Objective: To review the pharmacology, pharmacokinetics, efficacy, and safety of liraglutide, a glucagon-like peptide 1 (GLP-1) analog for the treatment of type 2 diabetes mellitus. Data Sources: A MEDLINE search (1966–May 2009) was conducted for English-language articles using the terms glucagon-like peptide 1, incretin mimetic, NN2211, and liraglutide. Abstracts presented at the American Diabetes Association and European Association for the Study of Diabetes annual meetings in 2006, 2007, and 2008 were also searched for relevant data. Study Selection and Data Extraction: Articles pertinent to the pharmacology, pharmacokinetics, efficacy, and safety of liraglutide were reviewed. Data Synthesis: Liraglutide is a GLP-1 analog with pharmacokinetic properties suitable for once-daily administration. Clinical trial data from large, controlled studies demonstrate the effectiveness of liraglutide in terms of hemoglobin A1c (A1C) reduction, reductions in body weight, and the drug's low risk for hypoglycemic events when used as monotherapy. Data also support benefits of liraglutide therapy on β-cell responsiveness to glucose, with animal and in vitro data indicating potential benefits in β-cell mass and neogenesis with liraglutide treatment. Liraglutide has been studied as monotherapy and in combination with metformin, glimepiride, and rosiglitazone for the treatment of type 2 diabetes. Additionally, comparative data with insulin glargine and exenatide therapy are available from Phase 3 trials providing practitioners valuable clinical data on which to base clinical decision making. Overall, liraglutide is well tolerated with dose-dependent nausea, vomiting, and diarrhea being the most commonly reported adverse events in clinical trials. Conclusions: Once-daily administration may provide a therapeutic advantage for liraglutide over twice-daily exenatide, with similar improvements in A1C and body weight observed when liraglutide was compared with exenatide. The glucose-dependent mechanism of insulin release with GLP-1 agonist therapy holds potential clinical significance in the management of postprandial hyperglycemic excursions, with minimal risk of hypoglycemia.

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Efficacy and Safety of Sodium-Glucose Cotransporter-2 Inhibitors in Korean Patients with Type 2 Diabetes Mellitus in Real-World Clinical Practice

Diabetes & Metabolism Journal ◽

10.4093/dmj.2018.0134 ◽

2019 ◽

Vol 43 (5) ◽

pp. 590 ◽

Cited By ~ 6

Author(s):

A Ram Hong ◽

Bo Kyung Koo ◽

Sang Wan Kim ◽

Ka Hee Yi ◽

Min Kyong Moon

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Clinical Practice ◽

Real World ◽

Efficacy And Safety ◽

Korean Patients ◽

Sodium Glucose Cotransporter

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Somatotype Characteristics of Female Patients with Type 2 Diabetes Mellitus / Характеристика Соматотипа Жен Щин, Больных Сахарным Диабетом Типа 2

Folia Medica ◽

10.2478/folmed-2013-0007 ◽

2013 ◽

Vol 55 (1) ◽

pp. 64-69 ◽

Cited By ~ 3

Author(s):

Atanas G. Baltadjiev

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Body Weight ◽

Diabetic Patients ◽

Old Patients ◽

Female Patients ◽

Arm Circumference ◽

The Mean

Abstract The AIM of the present study was to determine the somatotype of females patients with type 2 diabetes mellitus. MATERIAL AND METHODS: Two-hundreds and twelve female patients with type 2 diabetes mellitus were measured. The patients were of Bulgarian ethnicity and were divided into two age groups: Group 1: 40-60 years of age and Group 2: 61-80 years of age. The control group comprised healthy females of Bulgarian ethnicity without any metabolic, neoplastic, or other disease divided into age matched groups. Measurements obtained directly were height, body weight, biepicondylar width of humerus, biepicondylar width of femur, arm circumference in relaxed state, arm circumference in contracted state, and calf circumference. Skin folds: subscapular, suprailiac, over triceps and calf. Parameters calculated: the components of the Heath-Carter anthrpometric somatotype. RESULTS: The mean somatotype of 40-60-year-old female diabetics was mesomorph endomorph, (meso 6.09; endo 6.59; ecto 1.57). The mean somatotype of 40-60-year-old female controls was mesomorphic endomorph (meso 5.65; endo 6.82; ecto 2.75). The mean somatotype of 61-80-year-old diabetic females was endomorphic mesomorph (endo-mesomorph), (meso 9.41; endo 5.39; ecto 1.55). The mean somatotype of 61-80-year-old female controls was mesomorph-endomorph (meso 6.70; endo 6.66; ecto 2.95). Between-age comparison of female diabetics: the endomorph component dominated in the group of 40-60-year-old patients, and the mesomorph component dominated in the group of 61-80-year-old patients. In both groups ectomorphy markedly lagged behind. CONCLUSION: The mean somatotype of diabetic females aged 40-60 years is mesomoph-endomorph; it differs from the mesomorphic mesomorph somatotype of the control subjects. Endomorphy and mesomorphy dominate clearly, and ectomorphy significantly lags behind. This was the reason we get a distorted somatoplot with a sharp shift to endomorphy and mesomorhpy. The mean somatotype of diabetic women aged 60-80 years was endomorphic mesomorphy with the mesomorphy component leading. It differed from the somatotype of the controls, where mesomorphy and endomorphy scored equally (mesomorph-endomorph). The somatotype of female diabetics suggests that they have a relatively massive skeleton with well-developed muscles and greater body weight relative to height. Unlike the results of studies in other countries presenting with markedly dominating endomorphy, in our study the Bulgarian diabetic females presented with dominating mesomorphy. This can be regarded as a peculiarity of the Bulgarian diabetic patients. The somatotype of the Bulgarian diabetic females is more favorable on the risk, course and prognosis of the disease.

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