Semaglutide as an Adjunct to Dieting in the Treatment of Type 2 Diabetes - Effects on Glucose Metabolism, Prevention of Weight Regain and Peripheral Tissue Metabolic Activation
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
The pharmacological approaches in the treatment of type 2 diabetes (T2DM) have advanced radically during the last decades. However, focus on long-term management of body weight, which is an essential part of treatment success, is often lacking. Excluding surgery, there are only a few effective treatment methods for obesity. Management of obesity is also greatly challenged by weight regain, which is common after a successful lifestyle intervention. Weight regain typically results in the deterioration of glucose homeostasis in T2DM. However, understanding the pathomechanisms of weight regain and subsequent worsening of glucose homeostasis is still insufficient. Therefore, T2DM treatment programs that target long-term weight management have been scarce. This study aims to fill the gaps in the current knowledge by advancing the development of treatment programs for T2DM that simultaneously head for improved glucose metabolism and improved long-term body weight control.
详细描述
In this randomized, double-blind, parallel, placebo-controlled trial we compare the effects of semaglutide 1.34 mg/ml vs. normal dieting by randomizing the patients with both T2DM and overweight/obesity (BMI ≥27) (n=50, aged ≥18 to < 65 years) to two groups: both groups participate in a similar lifestyle treatment to induce weight loss, but one group gets an add-on of semaglutide 1.34mg/ml while the other is treated with placebo. Additionally, a reference group of healthy normal weight non-diabetic individuals (BMI ≤ 25 kg/m2, n=25, aged ≥18 to < 65 years) are included as controls at the initiation of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and <65 years
- •BMI: ≥27 kg/m2
- •T2DM (HbA1c ≥ 6.0% if on anti-diabetic medication or HbA1c≥6.5% if non- medicated)
- •Participant is willing and able to give informed consent for participation in the study
排除标准
- •Contraindication to trial drugs
- •Use of insulin or GLP-1RAs (during the past 3 months)
- •Use of anti-obesity drugs (during the past 3 months)
- •Weight change of >5% during the past 3 months
- •Bariatric surgery or planned bariatric surgery during the trial
- •History of pancreatitis
- •Impaired renal function (GFR<30 ml/min/1.73m2)
- •Impaired hepatic function (ALAT>2 x upper limit normal)
- •Clinically significant active cardiovascular disease
- •Clinically significant abnormality in the ECG
- •Cancer (except basal or squamous cell skin cancers)
- •Major psychiatric disease (such as severe depression, bipolar disorder, schizophrenia)
- •Substance abuse
- •Learning disability
- •Females of childbearing potential not using adequate contraceptive methods
- •Pregnancy
- •Lactation
- •Any other condition that in the opinion of the investigator could interfere with the conduction of the study or interpretation of the study results
研究组 & 干预措施
Semaglutide
The intervention study for the patients with T2DM begins with a low-calorie diet (LCD) phase run-in for 13 weeks. During re-introduction of food, the participants will be assigned to semaglutide 1.34mg/ml treatment for 44 weeks (dose escalation in total 8 weeks, maintenance period for 36 weeks).
干预措施: Semaglutide, 1.34 mg/mL (Drug)
Placebo
The intervention study for the patients with T2DM begins with a low-calorie diet (LCD) phase run-in for 13 weeks. During re-introduction of food, the participants will be assigned to placebo treatment for 44 weeks (dose escalation in total 8 weeks, maintenance period for 36 weeks).
干预措施: Placebo (Drug)
结局指标
主要结局
HbA1c
时间窗: from baseline to 12 months
Change in HbA1c (%)
次要结局
- Waist circumference(from baseline to 6 and 12 months)
- Change in appetite and eating habits, emotional, external and restraint eating(from baseline to 6 and 12 months)
- Body weight(from baseline to 6 and 12 months)
- Percentage of patients reaching ≥5%,10% & 15% weight loss(from baseline to 6 and 12 months)
- Fasting plasma glucose(from baseline to 6 and 12 months)
- Change in appetite and eating habits, control of eating(from baseline to 6 and 12 months)
- Change in appetite and eating habits, binge eating(from baseline to 6 and 12 months)
- HbA1c(from baseline to 6 months)
- Blood pressure(from baseline to 6 and 12 months)
- Mitochondrial DNA quantification(from baseline to 6 and 12 months)
- Plasma lipids(from baseline to 6 and 12 months)
- Changes in concomitant antihypertensive medications(from baseline to 6 and 12 months)
- Change in the transcriptomics profile of adipose tissue and skeletal muscle(from baseline to 6 and 12 months)
- Change in the oxygen uptake and perfusion in subcutaneous and intra-abdominal adipose tissue, brown adipose tissue, skeletal muscle, gut and liver(from baseline to 12 months)
- Changes in concomitant antidiabetic medications(from baseline to 6 and 12 months)
- Changes in concomitant lipid medications(from baseline to 6 and 12 months)
研究者
Kirsi Pietiläinen
Professor
Helsinki University Central Hospital