None listed
Conditions
Interventions
IN TOTAL, IT IS PLANNING TO INCLUDE AT LEAST 108 PATIENTS WITH TYPE 2 DIABETES THAT MEET THE SELECTION CRITERIA IN THIS STUDY TO FINALLY ACCOUNT WITH 100 PATIENTS TO COMPLETE THE STUDY. TREATMENT WILL
Sponsors
Boehringer Ingelheim,
Eligibility
Age
10 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. PEDIATRIC PATIENTS (CHILD AND ADOLESCENT) 10 TO 17 YEARS IN THE TIME OF SELECTION (IT MEANS, IN THE 1A VISIT) 2. DOCUMENTED DIAGNOSIS OF TYPE 2 DIABETES MELLITUS AT LEAST 3 MONTHS BEFORE THE RANDOMIZATION (IE, THE VISIT 2) 3. INADEQUATE GLYCEMIC CONTROL (IE, A VALUE OF HBA1C> 7.0% and ≤ 10.0%) IN THE SELECTION (IT MEANS, IN THE VISIT 1A) DESPITE TREATMENT WITH DIET AND EXERCISE ONLY. 4. NEGATIVE FOR ISLET CELL ANTIGEN (ICA) AUTOANTIBODIES AND GLUTAMIC ACID DECARBOXYLASE (GAD) AUTOANTIBODIES IN THE VISIT 2 5. PEPTIDE LEVELS C (SERUM) ≥ 1.5 NG / ML (90 MINUTES AFTER THE TEST OF TOLERANCE) DURING THE VISIT 2 6. COMPLIANCE DURING OPEN PERIOD BETWEEN INDUCTION PLACEBO 75% AND 125%. 7. WRITTEN INFORMED CONSENT PROVIDED BY THE PARENT (S) OF THE PATIENT (OR GUARDIAN) AND MINOR´S AGREEMENT SIGNED BY THE PATIENT, NOT LATER THAN THE DATE OF VISIT 1A, ACCORDING TO THE PCM AND LOCAL LAW . MINOR´S AGREEMENT TO BE OBTAINED WITH PATIENT AGE, MATURITY LEVEL OF COMPETITION AND CAPACITY. ALL FORMS OF INFORMED CONSENT / ASSENT OF MINOR TO OBEY ICH-GCP GUIDELINES AND LOCAL REQUIREMENTS OF IEC / IRB.
Exclusion criteria
Exclusion criteria: 1. UNCONTROLLED HYPERGLYCEMIA WITH A GLUCOSE LEVEL > 240 mg/dL (> 13.3 mmol/l) AFTER AN OVERNIGHT FAST DURING PLACEBO RUN-IN AN CONFIRMED BY A SECOND MEASUREMENT (NOT ON THE SAME DAY). 2. HISTORY OF ACUTE METABOLIC DECOMPENSATION, SUCH AS DIABETIC KETOACIDOSIS, WITHIN 3 MONTHS OF SCREENING (ie., VISIT 1A) 3. CURRENT INSULIN THERAPY, OR HAVING RECEIVED INSULIN FOR > 4 WEEKS WITHIN 3 MONTHS PRIOR TO THE RANDOMIZATION (ie., VISIT 2) 4. TREATMENT WITH WEIGHT REDUCTION MEDICATIONS (INCLUDING ANTI- OBESITY TREATMENTS) WITHIN 3 MONTHS PRIOR TO RANDOMIZATION (ie., VISIT 2) 5. CHRONIC TREATMENT - TREATMENT DURATION OF MORE THAN TWO WEEKS - WITH MEDICATION KNOWN TO AFFECT GLUCOSE METABOLISM (eg., METFORMIN OR SYSTEMIC CORTICOSTEROIDS) WITHIN 3 MONTHS PRIOR TO RANDOMIZATION (ie., VISIT 2) 6. ANTICIPATED NEED FOR TREATMENT WITH PGP (P-GLYCOPROTEIN) AND CYP 3A4 INHIBITORS OR INDUCERS DURING THE PLACEBO (VISIT 1B ONWARDS) AND RANDOMIZED (VISITS 2-6) OF THE STUDY (SEE APPENDIX 10.4 FOR A LIST OF PROHIBITED MEDICATIONS).
Countries
Canada, France, Italy, Korea North, Mexico, Poland, Russian Federation, United States
Contacts
Public ContactPaloma de Almenara
RPS PERU S.A.C
Outcome results
None listed