Basal Insulin as Add-On Therapy to Oral Glucose-Lowering Drugs in Insulin Naive Patients with Type 2 Diabetes Mellitus in Primary Public Health Center (original) (raw)
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Diabetes Research and Clinical Practice, 2013
To determine the safety and effectiveness of insulin detemir (IDet) in type 2 diabetes patients from the ASEAN cohort of the A1chieve study. Patients from Indonesia, Malaysia, Philippines and Singapore prescribed IDet at the discretion of their physicians were included. The primary outcome was the incidence of serious adverse drug reactions including major hypoglycaemia over 24 weeks. Secondary endpoints included changes in the frequency of hypoglycaemia, serious adverse events and effectiveness assessments. This sub-analysis included 1540 patients (insulin-naive, 1239; insulin-experienced, 301) with mean age ± SD 56.4 ± 10.9 years, BMI 25.4 ± 4.6 kg/m(2) and diabetes duration 6.9 ± 5.3 years. Insulin-naive patients received a baseline IDet dose of 0.24 ± 0.11 U/kg titrated up to 0.37 ± 0.21 U/kg by Week 24. The pre-study insulin dose in insulin-experienced patients was 0.41 ± 0.25 U/kg and baseline IDet dose was 0.31 ± 0.24 U/kg titrated up to 0.40 ± 0.20 U/kg by Week 24. Overall hypoglycaemia decreased from 1.73 to 0.46 events/patient-year from baseline to Week 24 (change in proportion of patients affected, p < 0.0001). At Week 24, 1 major hypoglycaemic event was reported in 1 insulin-experienced patient. IDet significantly improved glucose control (p < 0.001) at Week 24. The lipid profile and systolic blood pressure improved (p < 0.001) and body weight did not change significantly. Quality of life was positively impacted (p < 0.001). IDet was well-tolerated and improved glycaemic control without increasing the risk of hypoglycaemia or weight gain.
Diabetes Research and Clinical Practice, 2013
Aim: To determine the safety and efficacy of insulin detemir in Indonesian patients with type 2 diabetes (T2D) as a sub-analysis of the 24-week, prospective, multinational, non-interventional A 1 chieve study. Methods: This study included 477 Indonesian T2D patients starting insulin detemir at the discretion of their physicians. Safety and efficacy was measured in routine clinical practice at baseline, interim (around 12 weeks from baseline) and final (around 24 weeks from baseline) visit. Results: At baseline the mean age, duration of diabetes and mean BMI were 55.3±8.5 years, 5.9±4.0 years and 24±3.6 kg/m 2 , respectively. Of these patients, 78% were insulin-naive and 22% were prior insulin users. Glycaemic control was poor at baseline. After 24 weeks, significant reductions were observed in mean HbA 1c (2.2%, p < 0.001), fasting plasma glucose (90.0 mg/dL, p < 0.001) and postprandial plasma glucose (115.4 mg/dL, p < 0.001) levels, in the entire cohort. Similar significant reductions were also seen in insulin-naive patients and prior insulin users. In the entire cohort, 32.5% patients achieved HbA 1c levels <7.0% while 32.0% insulin-naive patients and 33.9% prior insulin users achieved this target after 24 weeks. No hypoglycaemic events were reported in the entire cohort. Modest increase in body weight was noted in the insulinnaive group, while mean body weight decreased in prior insulin users after 24 weeks of insulin detemir therapy. Conclusion: This sub-analysis suggests that insulin detemir can be a safe and effective option for initiating insulin therapy in people with T2D in Indonesia.
Journal of Diabetes, 2011
Background: The First Basal Insulin Evaluation (FINE) Asia study is a multinational, prospective, observational study of insulin-naı¨ve Type 2 diabetes mellitus (T2DM) patients in Asia, uncontrolled (A1c ‡ 8%) on oral hypoglycemic agents, designed to evaluate the impact of basal insulin initiation. Methods: Basal insulin was initiated with or without concomitant oral therapy and doses were adjusted individually. All treatment choices, including the decision to initiate insulin, were at the physician's discretion to reflect real-life practice. Results: Patients (n ¼ 2679) from 11 Asian countries were enrolled (mean [±SD] duration of diabetes 9.3 ± 6.5 years; weight 68.1 ± 12.7 kg; A1c 9.8 ± 1.6%). After 6 months of basal insulin (NPH insulin, insulin glargine, or insulin detemir), A1c decreased to 7.7 ± 1.4%; 33.7% patients reached A1c <7%. Fasting blood glucose (FBG) decreased from 11.7 ± 3.6 to 7.2 ± 2.5 mmol ⁄ L and 36.8% of patients reached FBG <6.1 mmol ⁄ L. The mean daily insulin dose prescribed increased marginally from 0.18 to 0.23 U ⁄ kg per day at baseline to 0.22-0.24 U ⁄ kg per day at Month 6. Mean changes in body weight and reported rates of hypoglycemia were low over the duration of the study. Conclusions: Initiation of insulin therapy is still being delayed by approximately 9 years, resulting in many Asian patients developing severe hyperglycemia. Initiating insulin treatment with basal insulin was effective and safe in Asian T2DM patients in a real-world setting, but insulin needs may differ from those in Western countries.
Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy
Indonesia is struggling with a rapidly growing burden of diabetes due to rapid socioeconomic transition. People with type 2 diabetes mellitus (T2DM) need appropriate treatment strategies to maintain glycemic control. New modalities with simplicity, such as fixed-ratio combination of basal insulin and glucagon-like peptide-1 receptor agonist (GLP-1 RA), further referred to as FRC, have proven to be an effective and practical therapeutic approach that may address this issue. In January 2021, a scientific expert meeting was held with the participation of endocrinologists from Indonesia to provide expert opinions regarding the optimal practical use of the FRC basal insulin/GLP1-RA. Topics discussed in the meeting included the challenges in diabetes management, clinical inertia with insulin therapy, local and international guideline positioning, initiation, titration, and switching of basal insulin and GLP-1 RA, including FRC, and the management of T2DM.
Diabetes, Obesity and Metabolism, 2012
Aims: Evaluate the safety and efficacy of once-daily insulin detemir initiated in routine clinical practice in patients with type 2 diabetes mellitus inadequately controlled with oral hypoglycaemic agents (OHAs). Methods: This large observational study was conducted in 10 countries. Adverse event data (including hypoglycaemia) and glycaemic control were recorded before and 24 weeks following insulin initiation while patients continued routine clinical management. Results: In this study, 17 374 patients (53% male) were included. Mean pre-insulin values (±s.d.) were: age 62 ± 12 years; body mass index (BMI) 29.3 ± 5.4 kg/m 2 ; diabetes duration 10 ± 7 years; haemoglobin A1c (HbA1c) 8.9 ± 1.6%. During the study, 27 patients experienced serious adverse drug reaction, severe hypoglycaemic events or both; and there were 31 episodes of severe hypoglycaemia in 21 patients. After 24 weeks, HbA1c was 7.5 ± 1.2% (change of −1.3%; p < 0.001) and mean weight change was −0.6 kg (confidence interval −0.7, −0.5 kg, p < 0.001). Daily insulin dose increased from 13 ± 6 U (0.16 ± 0.09 U/kg) to 22 ± 16 U (0.27 ± 0.17U/kg) by 24 weeks. Multivariate regression analysis identified several independent demographic and treatment predictors of end of study HbA1c. Conclusions: Addition of once-daily insulin detemir to patients with type 2 diabetes mellitus on OHA therapy resulted in few adverse events, significant improvements in glycaemic control, small reductions in weight and low rates of hypoglycaemia. On the basis of this study, concerns about hypoglycaemia or weight gain should not preclude initiation of basal insulin analogues in patients with poor glycaemic control on OHAs.
Acta medica Indonesiana, 2018
BACKGROUND hypoglycemia is a major adverse event of insulin therapy for diabetes mellitus patients. The study was conducted to evaluate the incidence of hypoglycemia among insulin treated patients with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) in the Indonesian cohort. METHODS this Indonesian cohort study consisted of retrospective and prospective evaluation of hypoglycemic episodes, using International Operations Hypoglycemia Assessment Tool (IO HAT) in 374 patients with diabetes (T1DM; n=17 or T2DM; n=357). The patients of ≥18 years of age and treated with insulin for >12 months were selected for this study (ClinicalTrials.gov number: NCT02306681). RESULTS a total of 374 patients were enrolled in this study and completed SAQ1. All patients with T1DM (17 [100%]), and 347 (97.2%) patients with T2DM completed SAQ2. Almost all the patients in the 4-week prospective period reported at least one hypoglycemic event (T1DM 100%, T2DM 99.4%) and the incidence rat...
Review of Insulin Therapy In Type 2 Diabetes Mellitus Ambulatory Patients
INDONESIAN JOURNAL OF PHARMACY
The purposes of this study were to review utilization of insulin therapy in type 2 diabetes mellitus out patients and identify its Drug Related Problems (DRP). The data were collected crosssectionally with purposive sampling method in the period March 2016 until May 2016 in Outpatient Clinic of Teaching Hospital Universitas Airlangga Surabaya. The results of 240 patients showed that insulin was used as monotherapy (insulin) in 2.9% patients; combination 1 insulin & 1-4 OAD in 31.3%; basal bolus therapy 27.9%; combination basal-bolus therapy & 1-3 OAD 43.9%. Based on blood glucose target achievement, only 20.8% of patients achieve the target, 75.1% failed to achieve the target and 4.1% suffered from hypoglycemia. DRP identified adverse drug reaction of antidiabetic therapy such as hypoglycemia (6.7%), nausea (3.8%), bloating (1.3%), increase of flatulency (2.9%) and inappropriate combination (0.4%) were observed. In conclusion insulin therapy was complicated and individually, most of the patients still did not achieve the target and there was potential DRP in this patients group. Therefore caring from solid inter-professional health collaboration is needed.
Diabetes Research and Clinical Practice, 2013
Type 2 diabetes Aims: This subgroup analysis of the A 1 chieve study examined data from 15,545 people who started treatment with insulin detemir ± oral glucose-lowering drugs in routine clinical care. Methods: A 1 chieve was a 24-week, international, prospective, non-interventional study of people with type 2 diabetes from non-Western nations starting treatment with basal insulin detemir, bolus insulin aspart or biphasic insulin aspart 30, alone or in combination, to evaluate their safety and effectiveness in routine clinical practice. Results: HbA 1c for the global cohort improved after 24 weeks from 9.5 ± 1.6% by −2.0 ± 1.6% [80 ± 17 by −22 ± 17 mmol/mol] (−2.1 ± 1.6% [−23 ± 17 mmol/mol] for insulin-naïve participants; −1.6 ± 1.7% [−17 ± 19 mmol/mol] for prior insulin users). Fasting plasma glucose and postprandial plasma glucose were also significantly reduced (p < 0.001), irrespective of prior therapy or geographical region. The incidence of major hypoglycaemia decreased significantly over 24 weeks in both the insulin-naïve and insulin-experienced groups (p < 0.0001). Mean body weight decreased overall by −0.4 ± 4.0 kg and blood pressure, lipid profiles, and self-reported quality of life improved over 24 weeks for all people starting treatment with insulin detemir. Conclusion: People with type 2 diabetes in poor glycaemic control starting treatment with insulin detemir reported significant improvements in glycaemic control with improved treatment tolerability, irrespective of prior treatment and geographical region, after 24 weeks.