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

NCT04854083 | Unknown Phase 4

• 1 other identifier: 2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes

Keywords

weight loss; dieting

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Change in HbA1c (%)

  from baseline to 12 months

Secondary Outcomes (16)

• HbA1c

  from baseline to 6 months

• Fasting plasma glucose

  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

• Waist circumference

  from baseline to 6 and 12 months

Study Arms (2)

Semaglutide

EXPERIMENTAL

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).

Drug: Semaglutide, 1.34 mg/mL

Placebo

PLACEBO COMPARATOR

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).

Drug: Placebo

Interventions

Semaglutide, 1.34 mg/mL 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.

Also known as: Ozempic

Semaglutide

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kirsi Pietiläinen: lead
• University of Helsinki: collaborator
• Turku University Hospital: collaborator

Study Sites (1)

University of Helsinki

Helsinki, Finland

RECRUITING

MeSH Terms

Conditions

Weight Loss

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kirsi Pietiläinen, MD PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirsi H Pietiläinen, MD PhD

CONTACT

+358505992295; kirsi.pietilainen@helsinki.fi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 22, 2021
• Study Start: February 17, 2022
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

FI (1)