NEWLY DIAGNOSED TYPE 1 DIABETES MELLITUS MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
Conditions
Interventions
Trade Name: METBAY*30CPR 500MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Metformin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form o
Sponsors
AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. one the following 3 criteria: 1a. symptoms of diabetes (polyuria, and/or polydipsia, and/or unexplained weight loss) and a plasma glucose above 200 mg/dl at any time of day without regard to time since last meal OR 1b. fasting (no caloric intake for at least 8 hours) plasma glucose above 126 mg/dl OR 1c. 2-h plasma glucose above 200 mg/dl during an oral glucose tolerance test performed as described by the World Health Organization, using a glucose load containing glucose dissolved in water AND 2. at least one antibody to GAD65, insulin (if on insulin for less than 2 weeks), IA2 Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Endocrine, liver, kidney, or celiac disease, any condition that may cause a low level of oxygen in the blood or poor circulation (eg severe congestive heart failure), metabolic acidosis (except for ketoacidosis at T1DM diagnosis), sexually active females, alcohol abuse, danazol, chlorpromazine, loop diuretics, breastfeeding, pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if the metformin administration, as adjunct treatment in adolescents recently diagnosed with T1DM, can preserve the residual ß-cell function preventing the c-peptide secretion failure during and overall at the end of the trial. In keeping with the DCCT conclusion that a treatment effect on c-peptide levels would have a beneficial effect on other outcomes, ADA established that an experimental treatment yielding a 50% higher mean c-peptide, or a 1.5-fold difference, would likely be considered meaningful in a clinical trial testing efficacy of preserving ß-cell function;Secondary Objective: To evaluate if during the trial period the metformin administration, as adjunct treatment in adolescents recently diagnosed with T1DM, can improve the blood glucose control and the glycemic stability, decrease HbA1c, the need of exogenous insulin, the number of hypoglycemic episodes, improve lipid profile, decrease the costs / benefits ratio.;Primary end point(s): preserve the residual ß-cell function preventing the c-peptide secretion | — |
Countries
Italy
Outcome results
None listed