E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 2 diabetes mellitus Diabetic bone disease |
Type 2 diabetes mellitus Diabetisk knoglesygdom |
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E.1.1.1 | Medical condition in easily understood language |
Diabetes (type 2) Bone health in diabetes |
Sukkersyge / diabetes (type 2) Knoglers helbred i diabetes |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
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 |
To investigate whether improved insulin sensitivity (by training and/or metformin use) in diabetics leads to increased bone turnover and bone reparation. |
At undersøge hvorvidt forbedret insulinfølsomhed hos diabetikere (opnået ved træning og eller metforminbehandling) medfører øget knogleturnover og knoglereparation. |
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E.2.2 | Secondary objectives of the trial |
To investigate whether improved insulin sensitivity (by training and/or metformin use) in diabetics leads to improved bone biomechanical properties (bone structure), bone marrow turnover, and changes in fat tissue and body composition. |
At undersøge hvorvidt forbedret insulinfølsomhed hos diabetikere (opnået ved træning og eller metforminbehandling) medfører forbedrede biomekaniske egenskaber i knogle (knoglestruktur), øget turnover målt i knoglemarven samt ændringer i fedtvæv og kropssammensætning. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Diagnosed type 2 diabetes mellitus Alder ≥ 45 years Male gender OR female gender and postmenopausality |
Diagnosticeret type 2 diabetes mellitus Alder ≥ 45 år Mandligt køn ELLER kvindeligt køn og overstået menopause |
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E.4 | Principal exclusion criteria |
Current or previous treatment with other antidiabetics than metformin Premature menopause (menopause before 40 years of age) Treatment with systemic glucocorticoids within 2 years Treatment with antiresorptive or bone anabolic drugs (ever) Lithium treatment (ever) Anticonvulsive treatment (ever) Current menopausal hormone replacement therapy eGFR < 60 ml/min Significant cardiovascular, endocrinological, renal, hepati, rheumatological, gastrointestinal or other illness Osteoporosis or other bone disease D-vitamine deficiency Recent bone fractures (6 months) Previous fractures in both ankles (tibia) or both wrists (radius) Active cancer within previous 5 years or other unstable medical illness Assessed inability to participate in trial-related interventions or examinations Allergy to relevant pharmaceuticals |
• HbA1c ≥ 90 mmol/mol • Præmatur menopause (menopause tidligere end 40-års-alderen) • Aktuel eller tidligere behandling med andre antidiabetika end metformin • Behandling med følgende lægemidler: o - Systemiske glukokortikoider (indenfor de seneste 2 år) o - Antiresorptive eller knogleanabole lægemidler (nogensinde) o - Litium (nogensinde) o - Antikonvulsiva (aktuelt) o - Menopausal hormonterapi (aktuelt) • Estimeret glomerulær filtrationsrate (eGFR) < 60 ml/min • Betydende kardiovaskulær, endokrinologisk, renal, hepatisk, rheumatologisk, gastrointestinal eller anden lidelse vurderet af investigator • Osteoporose eller anden knoglesygdom • Nylige knoglebrud (6 måneder) • Tidligere knoglebrud i enten begge ankler (tibia) eller begge håndled (radius) • Parathyroidea- eller calciummetaboliske lidelser • D-vitaminmangel (< 50 nmol/L) • Anden betydende medicinsk sygdom i ustabil fase eller aktiv cancersygdom indenfor de seneste 5 år, undtaget spino- eller basocellulær carcinom • Allergi overfor et af indholdsstofferne i forsøgsmedicinen • Manglende evne til at gennemføre træningsinterventionen
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E.5 End points |
E.5.1 | Primary end point(s) |
Bone turnover markers in blood |
Knogleturnovermarkører målt i blodet |
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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) |
Bone biomechanical properties (assessed by HRpQCT-scan) Bone marrow levels of bone turnover Body composition Fat tissue expression levels of metabolism-related genes and proteins Insulin sensitivity (measured as steady-state plasma glucose by insulin suppression test) |
Knoglers biomekaniske egenskaber (målt ved HRpQCT-skanning) Knoglemarvsniveauer af knogleturnover Kropssammensætning Fedtvævs ekspression af metabolismerelaterede gener og proteiner |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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 | Yes |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |