E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 2 diabetes |
Tyypin 2 diabetes |
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E.1.1.1 | Medical condition in easily understood language |
Type 2 diabetes |
Tyypin 2 diabetes |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | Type 2 diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to investigate the effect of semaglutide 1.34mg/ml treatment compared with placebo treatment on glucose homeostasis (HbA1c) in patients with T2DM following diet-induced weight loss intervention at 12 months. |
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E.2.2 | Secondary objectives of the trial |
The effects of semaglutide 1.34mg/ml compared with placebo: -on weight maintenance following diet-induced weight loss intervention at 12 months (body weight,adiposity-related measures) -on metabolic parameters (liver fat,blood pressure,lipids) following diet-induced weight loss intervention at 12 months -on appetite and eating habits using questionnaires Control of Eating,Binge Eating Scale,Dutch Eating Behaviour Questionnaire,Questionnaire on Eating and Weight Patterns -on adipose tissue and skeletal muscle metabolism and mitochondrial parameters following diet-induced weight loss intervention at 12 months -n oxygen uptake and perfusion-proxy measures of mitochondrial function-of tissues (subcutaneous and intra-abdominal adipose tissue,brown adipose tissue,skeletal muscle,gut and liver) using a PET and CT scanning before vs. after diet-induced weight loss intervention at 12 months -the differences of the above measures between patients with T2DM and healthy controls at baseline |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria for the group of type 2 diabetes - Age ≥18 years and <65 years - BMI: ≥27 kg/m2 - T2DM (HbA1c ≥ 6% 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
Inclusion criteria for the control group - Age ≥18 years and <65 years - BMI <25 kg/m2 - participants willing and able to give informed consent for participation in the study
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E.4 | Principal exclusion criteria |
Exclusion criteria for the group of type 2 diabetes -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
Exclusion criteria for the control group - T2DM - All others as above for the main study |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Change in HbA1c at 6 months - Change in fasting plasma glucose - Change in body weight - Percentage of patients reaching ≥5%,10% & 15% weight loss - Change in waist circumference - Change in appetite and eating habits - Change in blood pressure - Change in lipids (total cholesterol, LDL, HDL, TAG) - Changes in concomitant antidiabetic medications - Changes in concomitant antihypertensive medications - Changes in concomitant lipid medications - Change in mitochondrial DNA (mtDNA) copy number, RNA expression of mtDNA encoded genes in adipose tissue - Change in the transcriptomics profile of adipose tissue - Change in mitochondrial DNA (mtDNA) copy number, RNA expression of mtDNA encoded genes in skeletal muscle - Change in the transcriptomics profile of skeletal muscle - Change in the oxygen uptake and perfusion in subcutaneous and intra-abdominal adipose tissue, brown adipose tissue, skeletal muscle, gut and liver - Differences in glucose metabolism, body weight, adiposity-related measures, liver fat, eating habits, blood pressure, lipids, adipose tissue and skeletal muscle metabolism and oxygen uptake and perfusion of tissues between patients with T2DM and healthy controls at baseline |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Change in HbA1c from baseline to 6 months - Other secondary endpoints 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 from baseline to 12 months - Differences in glucose metabolism, body weight, adiposity-related measures, liver fat, eating habits, blood pressure, lipids, adipose tissue and skeletal muscle metabolism and oxygen uptake and perfusion of tissues differ between patients with T2DM and healthy controls at Baseline |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |