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

Primary Purpose

Type2 Diabetes

Status

Recruiting

Phase

Phase 4

Locations

Finland

Study Type

Interventional

Intervention

Semaglutide, 1.34 mg/mL

Placebo

About this trial

This is an interventional treatment trial for Type2 Diabetes focused on measuring weight loss, dieting

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of HelsinkiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Semaglutide

Placebo

Arm 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).

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).

Outcomes

Primary Outcome Measures

HbA1c

Change in HbA1c (%)

Secondary Outcome Measures

HbA1c

Change in HbA1c (%)

Fasting plasma glucose

Change in fasting plasma glucose (mmol/l)

Body weight

Change in body weight (kg)

Percentage of patients reaching ≥5%,10% & 15% weight loss

Waist circumference

Change in waist circumference (cm)

Change in appetite and eating habits, control of eating

Using questionnaire Control of Eating (CoEQ)

Change in appetite and eating habits, binge eating

Using questionnaires Binge Eating Scale(BES), Questionnaire on Eating and Weight Patterns (QEWP)

Change in appetite and eating habits, emotional, external and restraint eating

Using questionnaire Dutch Eating Behaviour Questionnaire (DEBQ)

Blood pressure

Change in blood pressure (mmHg)

Plasma lipids

Change in lipids (total cholesterol, LDL, HDL, TAG) (mmol/l)

Changes in concomitant antidiabetic medications

Change in number of antidiabetic medications

Changes in concomitant antihypertensive medications

Change in number of antihypertensive medications

Changes in concomitant lipid medications

Change in number of lipid medications

Mitochondrial DNA quantification

Change in mitochondrial DNA (mtDNA) copy number, RNA expression of mtDNA encoded genes in adipose tissue and skeletal muscle

Change in the transcriptomics profile of adipose tissue and skeletal muscle

Change in the transcriptomics profile by qPCR and/or RNA sequencing

Change in the oxygen uptake and perfusion in subcutaneous and intra-abdominal adipose tissue, brown adipose tissue, skeletal muscle, gut and liver

Change in the oxygen uptake and perfusion measured by PET/CT (in vivo)

Full Information

NCT ID

NCT04854083

First Posted

April 9, 2021

Last Updated

March 17, 2022

Sponsor

Kirsi Pietiläinen

Collaborators

University of Helsinki, Turku University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04854083

Brief Title

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

Acronym

MitoSema

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 17, 2022 (Actual)

Primary Completion Date

August 2025 (Anticipated)

Study Completion Date

August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Kirsi Pietiläinen

Collaborators

University of Helsinki, Turku University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type2 Diabetes

Keywords

weight loss, dieting

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Semaglutide

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm 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).

Intervention Type

Drug

Intervention Name(s)

Semaglutide, 1.34 mg/mL

Other Intervention Name(s)

Ozempic

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

HbA1c

Description

Change in HbA1c (%)

Time Frame

from baseline to 12 months

Secondary Outcome Measure Information:

Title

HbA1c

Description

Change in HbA1c (%)

Time Frame

from baseline to 6 months

Title

Fasting plasma glucose

Description

Change in fasting plasma glucose (mmol/l)

Time Frame