Type2 DiabetesPhase 4MitoSemaNCT04854083
Semaglutide as an Adjunct to Dieting in the Treatment of Type 2 Diabetes
A Phase 4 study testing Semaglutide, 1.34 mg/mL in people with Type2 Diabetes, run by Kirsi Pietiläinen at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Semaglutide, 1.34 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- 17 Feb 2022to Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
University of Helsinki
Helsinki
Kirsi Pietiläinen, +358505992295, kirsi.pietilainen@helsinki.fi
About this study
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
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.
Read the 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
- Being tested
- Semaglutide, 1.34 mg/mL, Placebo
- Keywords
- weight loss, dieting
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide, 1.34 mg/mLDrug
Also called Ozempic
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Change in HbA1c (%)
Measured: from baseline to 12 months
Secondary outcomes (16)
HbA1c
Change in HbA1c (%)
Measured: from baseline to 6 months
Fasting plasma glucose
Change in fasting plasma glucose (mmol/l)
Measured: from baseline to 6 and 12 months
Body weight
Change in body weight (kg)
Measured: from baseline to 6 and 12 months
Percentage of patients reaching ≥5%,10% & 15% weight loss
Measured: from baseline to 6 and 12 months
Waist circumference
Change in waist circumference (cm)
Measured: from baseline to 6 and 12 months
Change in appetite and eating habits, control of eating
Using questionnaire Control of Eating (CoEQ)
Measured: from baseline to 6 and 12 months
Change in appetite and eating habits, binge eating
Using questionnaires Binge Eating Scale(BES), Questionnaire on Eating and Weight Patterns (QEWP)
Measured: from baseline to 6 and 12 months
Change in appetite and eating habits, emotional, external and restraint eating
Using questionnaire Dutch Eating Behaviour Questionnaire (DEBQ)
Measured: from baseline to 6 and 12 months
Blood pressure
Change in blood pressure (mmHg)
Measured: from baseline to 6 and 12 months
Plasma lipids
Change in lipids (total cholesterol, LDL, HDL, TAG) (mmol/l)
Measured: from baseline to 6 and 12 months
Changes in concomitant antidiabetic medications
Change in number of antidiabetic medications
Measured: from baseline to 6 and 12 months
Changes in concomitant antihypertensive medications
Change in number of antihypertensive medications
Measured: from baseline to 6 and 12 months
Changes in concomitant lipid medications
Change in number of lipid medications
Measured: from baseline to 6 and 12 months
Mitochondrial DNA quantification
Change in mitochondrial DNA (mtDNA) copy number, RNA expression of mtDNA encoded genes in adipose tissue and skeletal muscle
Measured: from baseline to 6 and 12 months
Change in the transcriptomics profile of adipose tissue and skeletal muscle
Change in the transcriptomics profile by qPCR and/or RNA sequencing
Measured: 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
Change in the oxygen uptake and perfusion measured by PET/CT (in vivo)
Measured: from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start17 Feb 2022
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirsi Pietiläinen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki, Turku University Hospital
- Responsible party
- Sponsor-investigator, Kirsi Pietiläinen, Helsinki University Central Hospital
- Investigators
- Kirsi Pietiläinen, MD PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854083
- Sponsor's protocol ID
- 2020
- Acronym
- MitoSema
- Status last verified
- Mar 2022
- First submitted
- 9 Apr 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04854083
- Acronym / sponsor ID
- MitoSema / 2020
- Conditions
- Type2 Diabetes
- Keywords
- weight loss, dieting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kirsi PietiläinenUniversity, hospital or other
- Collaborators
- University of Helsinki, Turku University Hospital
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: Semaglutide, 1.34 mg/mLThe 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). |
| Placebo | Placebo comparator | Drug: PlaceboThe 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide, 1.34 mg/mLAlso: OzempicThe 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. | Drug | Semaglutide |
| PlaceboThe 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. | Drug | Placebo |
Primary outcome
HbA1c
Time frame: from baseline to 12 months
Change in HbA1c (%)
16 secondary outcomes
HbA1c
Time frame: from baseline to 6 months
Fasting plasma glucose
Time frame: from baseline to 6 and 12 months
Body weight
Time frame: from baseline to 6 and 12 months
Percentage of patients reaching ≥5%,10% & 15% weight loss
Time frame: from baseline to 6 and 12 months
Waist circumference
Time frame: from baseline to 6 and 12 months
Change in appetite and eating habits, control of eating
Time frame: from baseline to 6 and 12 months
Change in appetite and eating habits, binge eating
Time frame: from baseline to 6 and 12 months
Change in appetite and eating habits, emotional, external and restraint eating
Time frame: from baseline to 6 and 12 months
Blood pressure
Time frame: from baseline to 6 and 12 months
Plasma lipids
Time frame: from baseline to 6 and 12 months
Changes in concomitant antidiabetic medications
Time frame: from baseline to 6 and 12 months
Changes in concomitant antihypertensive medications
Time frame: from baseline to 6 and 12 months
Changes in concomitant lipid medications
Time frame: from baseline to 6 and 12 months
Mitochondrial DNA quantification
Time frame: from baseline to 6 and 12 months
Change in the transcriptomics profile of adipose tissue and skeletal muscle
Time frame: 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
Time frame: from baseline to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsi Pietiläinen, MD PhD principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide, 1.34 mg/mL in people with Type2 Diabetes, run by Kirsi Pietiläinen at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kirsi H Pietiläinen, MD PhD (+358505992295, kirsi.pietilainen@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: from baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.