An interventional study of Education in Diabetes Mellitus, Type 2, Education and Drug-Related Side Effects and Adverse Reactions, sponsored by University Hospital Dubrava. Completed at 1 site in Croatia. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-11-09.
Sponsored by University Hospital Dubrava · Not applicable, Interventional, and Supportive care
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Among 82 studies in Diabetes Mellitus, Type 2 with a site in Croatia — 6 open to participants now, 8 under way, 5 of them phase 3. Diabetes Mellitus, Type 2 · Croatia.
Among the 82 studies in Diabetes Mellitus, Type 2 with a site in Croatia, this one is the 65th largest by enrollment of the 77 interventional ones that give a count, is one of 4 that started in 2018, is one of 5 with no phase, and was the 60th registered.
10,382 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,411 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →6 of the 82 studies in Diabetes Mellitus, Type 2 with a site in Croatia are open now. Recruiting first, the newest first:
Novo Nordisk A/S · Sites in Croatia, United States, Hungary and 7 more countries
Ages 18–75
Boehringer Ingelheim · Sites in Croatia, United States, Argentina and 48 more countries
Ages 18+
University of Split, School of Medicine · Sites in Croatia
Ages 20–69
Novo Nordisk A/S · Sites in Croatia, United States, Argentina and 19 more countries
Ages 18+
Novo Nordisk A/S · Sites in Croatia, United States, Argentina and 13 more countries
Ages 18+
A study can be open while its sites in Croatia have not opened yet or have stopped. Only those recruiting at a site in Croatia →
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 205 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
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82 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 11 · Phase 3 52 · Phase 4 9
First in 2001; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 130 is above the median of 80 across 8,359 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 660 across the 77 interventional studies, 100 across the 5 observational. Of the 72 that completed or were terminated, 49 (68%) have results posted.
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70 of 82 have an industry lead sponsor. The 10 most frequent:
University Hospital Dubrava is the lead sponsor of 43 studies on the registry; 12 are open to participants now.
University Hospital Dubrava has 2 studies filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
3 of the studies in Diabetes Mellitus, Type 2 with a site in Croatia that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07220759Phase 3Novo Nordisk A/SWeight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide | 2027-05-12 |
| NCT07017127University of Split, School of MedicineRemission of Type 2 Diabetes With Lifestyle Intervention | 2027-06-01 |
| NCT07415954Novo Nordisk A/SA Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 Diabetes | 2027-09-03 |
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Among the 82 studies in Diabetes Mellitus, Type 2 with a site in Croatia, from their registry updates:
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Type 2 diabetes mellitus (T2DM) is a chronic progressive disease that affects more than 400 million people worldwide. There are a few studies evaluating ADRs in diabetics. Many patients experience ADRs soon after hospital discharge which can be attributed to the changes in the pharmacotherapy during hospitalization. Education and counseling of diabetic patients has been shown to improve medication adherence and clinical outcomes. Studies that included medical patients revealed that education can significantly reduce risk of ADRs after hospital discharge. Pharmacotherapeutic education is a part of comprehensive education of diabetics that is focused on a proper use of medications, prevention and early detection of ADRs.
Type 2 diabetes mellitus (T2DM) is a chronic progressive disease that affects more than 400 million people worldwide. Besides adapting their lifestyle, a large majority of diabetic patients needs pharmacotherapy to achieve adequate glycaemic control. Additional pharmacotherapy is usually needed for the treatment of concomitant diseases and risk factors. This can result in polytherapy which puts patients et risk of adverse drug reactions (ADRs). There are a few studies evaluating ADRs in diabetics. A prospective observation study reported ADRs in 11.8% of diabetic patients in tertiary care hospital. Many patients experience ADRs soon after hospital discharge which can be attributed to the changes in the pharmacotherapy during hospitalization. These ADRs can result in early readmission and emergency department (ED) visits. In an Italian study, ADRs were reported in 73.8% of patients taking oral antidiabetics drugs within one month of study enrollment. It is estimated that between 11-38% of ambulatory ADRs are preventable. Medication adherence plays an important role in the treatment of T2DM because it clearly improves glycaemic control and clinical outcomes and lowers medical costs. Adherence rates to DM medications vary from 31% to 87% in retrospective studies and 53% to 98% in prospective studies. It is affected by many factors such as age, race, health beliefs, medication cost, co-pays, etc. Adherence is lower in the case of ADRs, when medications are taken more than twice daily, with concomitant depression and skepticism about the importance of medication. In recent years, 30-day readmission rate has been emphasised as a measure of healthcare quality. Diabetic patients have higher readmission rate compared to patients without DM. In the study by Ostling and al., 30-day readmission rate for patients with DM was 26%. Many readmissions are drug-related and can be caused by ADRs and non-adherence. These readmissions are potentially preventable. It is estimated that between 40%-57.1% of readmissions caused by ADRs and all readmissions caused by non-adherence are preventable. Education and counseling of diabetic patients has been shown to improve medication adherence and clinical outcomes. Studies that included medical patients revealed that education can significantly reduce risk of ADRs after hospital discharge. Pharmacotherapeutic education is a part of comprehensive education of diabetics that is focused on a proper use of medications, prevention and early detection of ADRs. The aim of this study was to evaluate the impact of pharmacotherapeutic education on 30-day post discharge medication adherence and adverse outcomes (ADRs, readmissions, ED visits and death) in diabetic patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in both groups received diabetes education during the hospital stay. Standardized diabetes education includes education regarding the disease, diet, physical activity, alcohol intake, smoking, education regarding diabetes medication, self monitoring of glucose, and education regarding acute and chronic complications.
Patients in both groups received diabetes education during the hospital stay. Standardized diabetes education includes education regarding the disease, diet, physical activity, alcohol intake, smoking, education regarding diabetes medication, self monitoring of glucose, and education regarding acute and chronic complications. Patients randomized in the intervention group received pre-discharge pharmacotherapeutic education. The education was conducted by a qualified physician.
Behavioral: Education
Patients randomized in the intervention group received pre-discharge pharmacotherapeutic education. The education was conducted by a qualified physician.
Medication adherence assessment method
The medication adherence of the two diabetic patients groups (intervention group and group without intervention) 30 days after the recruitment in the study was assessed by the pill count method. Where adherence was in the range from 80% to 100% the patients were categorized as adherent, and where adherence was less than 80% or more than 100% the patients were categorized as non-adherent.
Time frame: one month
Adverse events questionnaire
The number of participants with treatment-related adverse events in the two diabetic patients groups (intervention group and group without intervention) 30 days after the recruitment in the study was compared using the questionnaire method which was conducted by the physician. The physician noted cause of the adverse event and marked its probability using the Naranjo adverse drug reaction probability scale. The Naranjo adverse drug reaction probability scale consists of 10 questions that are answered as either "Yes", "No", or "Do not know". Different point values (-1, 0, +1 or +2) are assigned to each answer. The adverse drug reaction is considered "definite" if the score is 9 or higher, "probable" if 5 to 8, "possible" if 1 to 4, and "doubtful" if 0 or less.
Time frame: one month
Plan to share: No
Ran from Apr 2018 to primary completion in Jul 2018, 3 months.
Of 2,068 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 3 months is below that.
Counting every sponsor, half of 2,245 studies reached it within 21 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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University Hospital Dubrava