The Effect of Adherence to Oral Semaglutide on Glycaemic Control in People With Type 2 Diabetes Treated With Metformin (DIACRON) - An Open-label Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Time-in-Range (TIR)
研究概览
简要总结
The objective of the trial is to investigate the effect of adherence to oral semaglutide dosing instructions on glycaemic control in people with type 2 diabetes, which are dysregulated on metformin and naïve to second line antidiabetic treatment.
详细描述
The trial is a prospective non-interventional clinical trial with a duration of 12 weeks and will be conducted at Steno Diabetes Center North Denmark (SDCN)/the Endocrinology Outpatient Clinic, Aalborg University Hospital.
The participants of this non-interventional clinical trial are people with T2D, which are dysregulated on metformin and naïve to second line antidiabetic treatment. As these patients do not have glycaemic control despite treat-ment with metformin and lifestyle interventions, the next recommended step in the treatment, according to current guidelines, is to add a second line antidiabetic to the treatment. As the treatment, according to guidelines, should be individualised, only patients which would start treatment with oral semaglutide independently of this trial are eligible for trial inclusion.
The trial period starts with the first visit to the trial site and ends 12 weeks later with the second visit to the trial site. A CGM baseline of each participant is collected prior to oral semaglutide initiation, corresponding to the two first weeks of the trial period. After oral semaglutide initiation, CGM data, physical activity, time of dosing, and water volume intake at dosing time are collected throughout the remaining trial period. The participants are asked to report occurrences of nausea and vomiting including time, duration, and severity (using a scale from 0-10, as previously described). In addition, the participants are asked to register time of breakfast at 3 time periods of the clinical trial.
The patient-reported adherence and satisfaction of the diabetes treatment is assessed using the TRIM-D, which is a questionnaire consisting of 28 questions, divided into five subcategories: treatment burden, daily life, diabetes management, compliance, and psychological health. The participants are asked to electronically answer the TRIM-D questionnaire at the start and end of the trial. The TRIM-D questionnaire is used in the validated Danish version. Data on health belief is obtained by asking the participants to answer the questionnaire developed by Given, et al. and adapted by Becker and Janz. The participants will furthermore be asked to answer a questionnaire on social support, developed by Sarason, et al. The questionnaires on health belief and social support are translated to Danish.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes for at least 1 year.
- •HbA1c of 53-75 mmol/mol at ???.
- •Treated with metformin for at least 1 year.
- •Can understand and read Danish.
- •Can use a smartphone, as well as the devices used in the clinical trial.
- •Signed informed consent.
排除标准
- •HbA1c value recorded less than 3 months prior to inclusion in trial.
- •Current or prior treatment with other glucose-lowering medications than metformin.
- •Cardiovascular disease or kidney disease which would indicate use of other second line treatments such as SGLT2 inhibitors or s.c. GLP1 receptor agonists (see also current guidelines https://endocrinology.dk/nbv/diabetes-melitus/behandling-og-kontrol-af-type-2-diabetes/).
- •Other types of diabetes than type 2 diabetes.
- •Participation in other trials.
- •Pregnancy or breastfeeding.
- •Known retinopathy.
- •Known allergy to semaglutide.
- •Major surgery planned during the trial period.
- •Cancer diagnosis within five years prior to inclusion.
- •Personal or family history of medullary thyroid carcinoma.
- •Multiple endocrine neoplasia syndrome type
- •Conditions, which the investigators deem to render the participant unfit for inclusion in the trial, including a physical or cognitive inability to participate in the trial.
研究组 & 干预措施
Study Cohort
People with dysregulated type 2 diabetes on metformin treatment, which are naïve to second line antidiabetic treatment. These participants will be started on oral semaglutide, as a second line antidiabetic treatment, in addition to their treatment with metformin. The participants will be started on 3mg and the dose increased according to the label. The oral semaglutide will be administered once daily.
结局指标
主要结局
Time-in-Range (TIR)
时间窗: Change from baseline to three-month assessment
Change from baseline to end-of-study in time-in-range (TIR) derived from CGM calculated in accordance with the International Consensus on Use of Continuous Glucose Monitoring.
次要结局
- Pre-dose Fasting(Time (minutes) elapsed from last registered food intake to registered medication intake.)
- Water Intake at Dosing Time(Collected during the entire trial duration, three months.)
- Treatment-Related Impact Measure for Diabetes (TRIM-D)(Change from baseline to end of trial (three-month assessment).)
- Post-dose Fasting(Time (minutes) elapsed from registered medication intake to registered time of breakfast (start).)
- Occurrence of nausea or vomiting(Reported during the entire trial duration, three months.)
研究者
Peter Vestergaard
Professor and Endocrinologist
Aalborg University Hospital