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

NCT ID: NCT04854083

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-17
• Study Completion Date: 2025-08-31

Brief Summary

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.

Detailed 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.

Conditions

Type2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Semaglutide, 1.34 mg/mL

Intervention Type: DRUG

The low-calorie diet (LCD) has a phase run-in period for 13 weeks for all participants including 8 weeks of total LCD followed 5-week gradual re-introduction of food (replacement of the VLCD products by one meal/week). During re-introduction of food, the subjects will be randomly assigned to semaglutide 1.34mg/ml (subcutaneous administration, dose escalation 0.25 mg once weekly for 4 weeks, 0.5 mg once weekly for 4 weeks, where after 1.0 mg once weekly) until the end of the study (12 months). The participants will receive lifestyle counselling throughout the study.

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).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The low-calorie diet (LCD) has a phase run-in period for 13 weeks for all participants including 8 weeks of total LCD followed 5-week gradual re-introduction of food (replacement of the VLCD products by one meal/week). During re-introduction of food, the subjects will be randomly assigned to placebo (subcutaneous administration, dose escalation 0.25 mg once weekly for 4 weeks, 0.5 mg once weekly for 4 weeks, where after 1.0 mg once weekly) until the end of the study (12 months). The participants will receive lifestyle counselling throughout the study.

Interventions

Semaglutide, 1.34 mg/mL

The low-calorie diet (LCD) has a phase run-in period for 13 weeks for all participants including 8 weeks of total LCD followed 5-week gradual re-introduction of food (replacement of the VLCD products by one meal/week). During re-introduction of food, the subjects will be randomly assigned to semaglutide 1.34mg/ml (subcutaneous administration, dose escalation 0.25 mg once weekly for 4 weeks, 0.5 mg once weekly for 4 weeks, where after 1.0 mg once weekly) until the end of the study (12 months). The participants will receive lifestyle counselling throughout the study.

Intervention Type: DRUG

Placebo

The low-calorie diet (LCD) has a phase run-in period for 13 weeks for all participants including 8 weeks of total LCD followed 5-week gradual re-introduction of food (replacement of the VLCD products by one meal/week). During re-introduction of food, the subjects will be randomly assigned to placebo (subcutaneous administration, dose escalation 0.25 mg once weekly for 4 weeks, 0.5 mg once weekly for 4 weeks, where after 1.0 mg once weekly) until the end of the study (12 months). The participants will receive lifestyle counselling throughout the study.

Intervention Type: DRUG

Other Intervention Names

Ozempic

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Helsinki

OTHER

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: collaborator

Kirsi Pietiläinen

OTHER

Sponsor Role: lead

Responsible Party

Kirsi Pietiläinen

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kirsi Pietiläinen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

University of Helsinki

Helsinki, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Kirsi H Pietiläinen, MD PhD

Role: CONTACT

kirsi.pietilainen@helsinki.fi

+358505992295

Facility Contacts

Kirsi Pietiläinen

Role: primary

kirsi.pietilainen@helsinki.fi

+358505992295

Other Identifiers

2020

Identifier Type: -

Identifier Source: org_study_id