This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.
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1 abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical study report had been prepared in accordance with best practice and applicable legal and regulatory requirements at the time of study completion. The synopsis may include approved and non approved uses, doses, formulations, treatment regimens and/or age groups; it has not necessarily been submitted to regulatory authorities. A synopsis is not intended to provide a comprehensive analysis of all data currently available regarding a particular drug. More current information regarding a drug is available in the approved labeling information which may vary from country to country.. Additional information on this study and the drug concerned may be provided upon request based on Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis is supplied for informational purposes only in the interests of scientific disclosure. It must not be used for any commercial purposes and must not be distributed, published, modified, reused, posted in any way, or used for any other purpose without the express written permission of Boehringer Ingelheim.
2 BI Trial No.: Post Marketing Surveillance Study Report Page 4 of SYNOPSIS Title Study Period Development Phase Objectives A Post-Marketing Surveillance Study on the Safety, Tolerability, and Efficacy of Linagliptin Among Filipino Patients with Type 2 Diabetes Mellitus 24 weeks Post-Marketing Surveillance (PMS) Primary Objective: To assess the safety and tolerability of Linagliptin in the treatment of Type 2 Diabetes Mellitus among Filipino patients. Secondary Objective: To measure the efficacy of Linagliptin by evaluating the change from baseline to endpoint in the glycosylated hemoglobin (HbA1c) and fasting blood sugar (FBS) of Filipino patients with Type 2 Diabetes Mellitus taking Linagliptin within the study duration of 24 weeks. Methodology This was a prospective, non-interventional, open label, multi-center, postmarketing surveillance study designed to assess the safety, tolerability and efficacy of Linagliptin among Filipino patients, male and female, 18 years old and above, with Type 2 Diabetes Mellitus within the study duration of 24 weeks. Patients had to complete two mandatory visits, baseline (week 0) and last visit (week 24 ± 2 weeks). Number of Patients Planned : 3,750 Actual : 678 Number of Sites The completed Case Report Forms (CRFs) were collected from 93 sites in the Philippines.
3 BI Trial No.: Post Marketing Surveillance Study Report Page 5 of 614 Diagnosis and main criteria for inclusion Patients were eligible to be included in the study if they met ALL of the following criteria: Filipino of Asian race, were patient using Linagliptin within label or locally approved indication, male or female patients 18 years old, body mass index 40 kg/m 2 diagnosed with Type 2 diabetes mellitus uncontrolled Type 2 diabetes mellitus with fasting blood sugar (FBS) of more than 126 mg/dl and/or HbA1c more than 7.0%. Patients were excluded from the study for any of the following reasons: diagnosed with Type 1 diabetes mellitus with acute illness requiring hospitalization in the past one month participated in a different study that includes an investigational drug with known hypersensitivity reaction to Linagliptin or any of its components pregnant and those women who have intentions of getting pregnant within the study duration nursing women with concomitant conditions that contraindicates Linagliptin use as described in its product information Dosage and Administration Linagliptin was administered 5 mg once a day which was within the authorized label. Filipino patients with Type 2 diabetes mellitus received Linagliptin and followedup according to current clinical practice guidelines as determined by the physician responsible throughout the study period. The study did not supply the drug and did not cover expenses for other medications, intervention, procedures or diagnostic test taken by the patient. Duration of Treatment weeks
4 BI Trial No.: Post Marketing Surveillance Study Report Page 6 of 614 Statistical Methods Patients demographic and other baseline characteristics were tabulated in descriptive tables. The analysis of safety endpoints consisted of descriptive statistics. The proportion of patients experiencing adverse events was recorded. The incidence of adverse events was computed. Adverse events were also summarized by severity and relationship to the treatment. Tolerability was analyzed by calculating the percentage of patients who stayed on treatment throughout the duration of the study and was compared to the percentage of patients who withdraw from the study due to adverse events. Efficacy analysis was performed on all patients who completed the study. Descriptive statistics such as mean, standard deviation, median, minimum, and maximum was used to describe continuous data. Frequency and percentage was used to summarize categorical data. No interim analysis was performed. Statistical analysis tables were generated using SAS version Results and Discussion This post marketing surveillance study was conducted in the Philippines from April 15, 2012 to October 2, There were 678 patients enrolled in the study and 97.3% were included in both safety and efficacy analysis population. Twenty patients did not complete the study or dropped out of the study. Majority were female patients (54.5%) with an average age of years old. The mean weight was kg while the mean body mass index was kg/m 2. Seventy eight percent of the patients were previously diagnosed with Type 2 Diabetes Mellitus (T2DM) while 22.1% were newly diagnosed and the most common T2DM complication was neuropathy with 32.7% of the patients. Majority of the patients had hypertension (67.9%) as their pre-existing illness/condition. Majority of the patients had normal physical examination. Among the abnormal findings at baseline, the following systems were commonly reported; eyes (6.5%), skin (6.2%), neurological (4.8%), and general appearance at 4.2%. Linagliptin was administered to the patients at an average (±SD) of (±4.6) weeks. The most common concomitant antihyperglycemic agent was metformin with 50.8% of the patients while telmisartan was the most common nonantihyperglycemic agent with 9.7% of the patients. Safety was the primary objective of this PMS. Only 5 patients (0.8%) experienced an adverse event (AE) and none of these events were deemed related to the study medication and none were serious. AEs recorded were anemia (0.2%), influenzalike illness (0.2%), upper respiratory tract infection (0.2%), urinary tract infection (0.2%), and muscle spasm (0.2%). All AEs were mild in intensity. No hypoglycemic event was reported and no patients dropped out of the study due to adverse events. Glycosylated hemoglobin significantly reduced from mean (±SD) baseline of 9.0% (±1.9) to follow up at 7.2% (±1.4) with a mean (±SD) change of -1.7% (±1.5). Fasting blood sugar was also reduced significantly from an average (±SD)
5 BI Trial No.: Post Marketing Surveillance Study Report Page 7 of 614 baseline of mg/dl (±65.5) to mg/dl(±39.6) at follow-up with a mean change of mg/dl. Treatment duration was not a significant factor in the levels of HbA1c change from baseline to follow up since there was no significant difference in the mean HbA1c and FBS change between patients who were followed up less than 22 weeks, weeks and more than 26 weeks with a p-value of for HbA1c and for FBS. Conclusion Linagliptin, an oral DPP-4 inhibitor administered among Filipino patients in the naturalistic setting for at least 24 weeks is safe and well tolerated. Linagliptin is effective in decreasing Glycosylated Hemoglobin and Fasting Blood Sugar from baseline to follow-up after 24 weeks of treatment.
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