Semaglutide as an Adjunct to Dieting in the Treatment of Type 2 Diabetes (MitoSema)

Kirsi Pietiläinen

Status and phase: Enrolling; Phase 4

Conditions: Type2 Diabetes

Treatments: Drug: Semaglutide, 1.34 mg/mL; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04854083

2020

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Semaglutide

Experimental group

Description:

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).

Treatment:

Drug: Semaglutide, 1.34 mg/mL

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: Placebo