Investigation of the effect of isomaltulose (PalatinoseTM) on metabolic parameters in subjects with Type 2 Diabetes.

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1 PLEASE NOTE: This trial has been registered retrospectively. Trial Description Title Investigation of the effect of isomaltulose (PalatinoseTM) on metabolic parameters in subjects with Type 2 Diabetes. Trial Acronym ISODIA URL of the trial [---]* Brief Summary in Lay Language The study investigates the effect of replacing 50g sucrose per day by isomaltulose in sweet food and beverages on metabolic control in subjects with type 2 diabetes. The study tests the hypothesis, whether isomaltulose vs. sucrose results in improved glycemic control assessed as HbA1c after 12 weeks. Brief Summary in Scientific Language The study investigates the effect of replacing 50g sucrose per day by the low-glycemic sugar isomaltulose in sweet food and beverages on metabolic control in subjects with type 2 diabetes under free-living conditions. Primary endpoint of the study is HbA1c at 12 weeks after study start. The aim of study is to test the hypothesis whether replacing 50 g/d sucrose by isomaltulose in sweet foods and beverages over a period of 12 weeks would result in improved glycemic control assessed as HbA1c as and metabolic parameters associated with cardiovascular risk in individuals with type 2 diabetes. Organizational Data DRKS-ID: DRKS Date of Registration in Partner Registry or other Primary Registry: [---]* Investigator Sponsored/Initiated Trial (IST/IIT): yes Ethics Approval/Approval of the Ethics Committee: Approved (leading) Ethics Committee Nr.: Projekt-Nr.: 1669/06, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München Page 1 of 6

2 DRKS-ID: DRKS Date of Registration in Partner Registry or other Primary Registry: [---]* Investigator Sponsored/Initiated Trial (IST/IIT): yes Ethics Approval/Approval of the Ethics Committee: Approved (leading) Ethics Committee Nr.: Projekt-Nr.: 1669/06, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München Secondary IDs Health condition or Problem studied Free text: Type 2 Diabetes ICD10: E Non-insulin-dependent diabetes mellitus; Without complications Interventions/Observational Groups Arm 1: 50 g per day sucrose by sweet foods and beverages over a period of 12 weeks Arm 2: 50 g per day isomaltulose by sweet foods and beverages over a period of 12 weeks Characteristics Study Type: Interventional Study Type Non-Interventional: [---]* Allocation: Randomized controlled trial Blinding: Double or multiple blind Who is blinded: [---]* Control: Active control Purpose: Other Assignment: Parallel Phase: N/A Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): N/A Page 2 of 6

3 Primary Outcome HbA1c after 12 weeks of treatment Secondary Outcome - Parameters of glucose metabolism (fasting glucose, insulin,c-peptide, fructosamine, HOMA-IR): baseline, after 6 and after 12 weeks (by an external laboratory according to standard procedures) - blood lipids (cholesterol, triglycerides): baseline, after 6 and after 12 weeks (by an external laboratory according to standard procedures) - Adipokines (leptin, adiponectin) baseline, after 6 and after 12 weeks (by ELISA) - nutritional intake over the course of the study (baseline, week 4, 6 and 10 by 3 day dietary records) - tolerance/ gastrointestinal parameters: clinical routine parameters (blood count, coagulation, liver enzymes) at baseline, after 6 and after 12 weeks; gastrointestinal parameters and stool characteristics by questionnaires fortnightly over the course of the study - self monitored blood glucose profiles fortnightly over the course of the study (before and 90 min after the three main meals) by a blood glucose meter handed out to the patients Countries of recruitment DE Locations of Recruitment University Medical Center Klinikum rechts der Isar, Technische Universität München, Else Kröner-Fresenius Zentrum für Ernährungsmedizin, München University Medical Center Medizinische Klinik und Poliklinik II, Schwerpunkt Gastroenterologie, Würzburg Recruitment Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2007/03/01 Target Sample Size: 110 Monocenter/Multicenter trial: Multicenter trial National/International: National Inclusion Criteria Gender: Both, male and female Page 3 of 6

4 Gender: Both, male and female Minimum Age: 18 Years Maximum Age: no maximum age Additional Inclusion Criteria written informed consent, sex: female or male, age >18 years, BMI kg/m2, confirmed type 2 diabetes mellitus, diabetes treatment with diet alone or oral antidiabetic agents (insulin secretagogues, metformin, insulin sensitizers, alpha-glucosidase inhibitors, dipeptidyl peptidase-4 inhibitors) without changes in the therapy regimen for at least three months prior to study start, HbA1c % assessed in the screening visit, usual daily intake of g sucrose or sucrose equivalent from sweetened foods or beverages assessed by 3-d dietary records before study start, willingness to regular consumption of test products, preference for sweet food in habitual diet, willingness to restrict intake of sweet foods other than the test products, 3 meals in the habitual diet Exclusion criteria treatment with insulin, presence or history of severe chronic disease, pregnancy and lactation, glucocorticoid therapy, abnormal dietary habits and dislike of sweetened foods. Addresses Primary Sponsor Else Kröner-Fresenius-Zentrum für Ernährungsmedizin Klinikum rechts der Isar Uptown München Campus D Mr. Prof. Dr. med Hans Hauner Georg-Brauchle-Ring 69/ München Telephone: Fax: hans.hauner at tum.de Page 4 of 6

5 Contact for Scientific Queries Else Kröner-Fresenius-Zentrum für Ernährungsmedizin Klinikum rechts der Isar Uptown München Campus D Mr. Prof. Dr. med. Hans Hauner Georg-Brauchle Ring 60/ München Telephone: Fax: hans.hauner at tum.de Contact for Public Queries Else Kröner-Fresenius-Zentrum für Ernährungsmedizin Klinikum rechts der Isar Uptown München Campus D Ms. M. Sc. Stefanie Brunner Georg-Brauchle-Ring 60/ München Telephone: Fax: stefanie.brunner at wzw.tum.de Sources of Monetary or Material Support Commercial (pharmaceutical industry, medical engineering industry, etc.) SÜDZUCKER AG Mannheim/Ochsenfurt Wormser Straße Obrigheim/Pfalz Telephone: [---]* Fax: [---]* [---]* Status Recruitment Status: Recruiting complete, follow-up complete Study Closing (LPLV): 2008/12/19 Page 5 of 6

6 Trial Publications, Results and other documents * This entry means the parameter is not applicable or has not been set. Page 6 of 6

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