E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes type 2 not controlled by oral medication. |
Typ-2-Diabetes auf orale Medikation nicht gesteuert. |
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E.1.1.1 | Medical condition in easily understood language |
Diabetes type 2 not controlled by oral medication. |
Typ-2-Diabetes auf orale Medikation nicht kontrolliert. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
MedDRA Classification |
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 main objectives of this study are to evaluate the efficacy of gastric stimulation (GCM) using the DIAMOND System in the improvement of glycemic control measured by changes in HbA1c. Relationship between blood TG level and the GCM efficacy will be evaluated. The effects of GCM on weight loss and associated co-morbid conditions will also be evaluated. |
Die Hauptziele der Studie sind die Evaluierung der Wirksamkeit einer gastralen Stimulation (GCM) durch das DIAMOND System, hinsichtlich einer verbesserten glykämischen Kontrolle, festgemacht an der Änderung des HbA1c, sowie die Feststellung des Zusammenhangs zwischen Triglyceridwerten im Blut und der GCM Wirksamkeit. Zusätzlich soll der Effekt der GCM bezüglich
einer Gewichtsreduktion und damit verbunden Komorbiditäten erhoben werden
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E.2.2 | Secondary objectives of the trial |
Not Applicable |
Nicht anwendbar |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male and female subjects 18 through 70 years of age
• Body mass index > 30 and < 45 (kg/m2)
• Type 2 diabetes duration of at least 6 months
• Type 2 diabetic subjects treated with oral anti-diabetic agents [Sulfonylurea, Metformin, thiazolinedione (TZD) or DPP-4 inhibitors]
• Stable anti-diabetic medications for at least 3 months prior to enrollment, six months for thiazolinedione (TZD)
• The subject has been under routine diabetes care of the investigator or another single physician that can supply a medical record for at least 6 months prior to enrollment
• HbA1c 7.3% and ≤ 9.5 % on Visit 1
• Stable HbA1c, defined as no significant change (variation ≤ 0.5%) between a historical value recorded in the subject’s medical record within 3 months prior to enrollment and the HbA1c gathered on Visit 1.
• Fasting blood glucose >120 and < 350 mg/dl on Visit 1.
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• Maennliche und Weibliche Probanden im Alter von 18 bis 70 Jahren
• Body mass index > 30 and < 45 (kg/m2)
• Typ 2 Diabetes seit mind. 6 Monaten
• Typ 2 Diabetiker mit oralen Medikamenten behandelt
• Stabile Diabetesmedikation fuer mindestens 3 Monate vor Einschluss
und 6 Monate Thiazolinedion (TZD)
• Der Proband wird routinemaeßig durch den Pruefarzt oder einen
anderen Spezialisten behandelt, der fuer mind. 6 Monate die
Krankengeschichte vorlegen kann.
• HbA1c 7.3% und ≤ 9.5 % bei 1. Untersuchung
• Stabiles HbA1c, definiert als keine signifikante Aenderung (Variation
≤ 0.5%) des historischen Wertes festgehalten in der Krankengeschichte
3 Monate vor Einschluss und dem HbA1c erhoben bei der 1.
Untersuchung.
• Nuechtern Blutzucker >120 and < 350 mg/dl bei 1. Untersuchung.
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E.4 | Principal exclusion criteria |
• Insulin therapy in last 3 months
• Taking GLP-1 agonists or in the last 3 months before the enrollment
• Currently taking fibrates, nicotinamide and omega 3 fatty acids as antilipidemic treatment
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• Insulintherapie in den letzten 3 Monaten
• Einnahme von GLP-1 Agonisten oder in den letzten 3 Monaten vor
Einschluss
• Derzeit Einnahme von Fibraten, Nicotinamiden and Omega 3
Fettsaeuren zur Lipidsenkung
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E.5 End points |
E.5.1 | Primary end point(s) |
Comparison of the differences in HbA1c levels between baseline before the implantation and 12 months post-implant for:
1. Low blood TG patients
2. High blood TG patients
3. High blood TG patients treated with blood TG lowering therapy concomitant with GCM therapy
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Vergleich der HbA1c-Werte zwischen den Ausgangsdaten vor der
Implantation und 12 Monate nach Implantation bei 1. Patienten mit
niedrigen Triglyceridwerten
2. Patienten mit hohen Triglyceridwerten und
3. Patienten mit hohen Triglyceridwerten und lipidsenkender Medikation
und mit GCM Therapie.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline vs 12 month post implant |
Ausgangswerte vs 12 Monate nach Implantation |
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E.5.2 | Secondary end point(s) |
1. Trends in weight loss will be of a reduction in weight during treatment in 3 patient groups
2. Trends in Meal Tolerance Test profile between baseline and 12 months post-implant for 3 patient groups
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1. Gewichtsentwicklung waehrend der gesamten Studiendauer in allen
drei Patientengruppen.
2. Veraenderungen des Mahlzeiten-Tolerant-Testprofil aller drei
Studiengruppen zwischen Studienbeginn (praeoperativ) und 12 Monaten
postoperativ
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline vs 12 month post implant |
Ausgangswerte vs 12 Monate nach Implantation |
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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 | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
semi-randomisiert |
semi-randomized |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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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After the last scheduled visit (week 48), subjects will be offered to keep the device. A post monitoring period of one year will follow (see protocol). Subjects willing to keep the device will be issued a new device warranty and turned over to their investigator to monitor as appropriate for their diabetes. Patients from the “HTG + placebo” might be offered fenofibrate treatment if found appropriate for the increase of GCM therapy efficiency. Any explant will be on behalf of the sponsor. |
Nach der letzten geplanten Untersuchung (Woche 48) wird den
Probanden angeboten, das Geraet zu behalten. Eine
Nachbeobachtungsperiode von einem Jahr folgt (s. Protokoll).
Probanden, die das Geraet behalten, erhalten eine neue
Geraetegarantie und werden vom Pruefarzt gemaess ihrer
Diabeteserkrankung beobachtet. Patienten mit "HTG + Placebo" kann
Fenofibrattherapie angeboten werden zur Steigerung der GCM-
Effektivitaet. Jegliche Explantation wird vom Sponsor uebernommen.
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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |