None listed
Conditions
Interventions
THE EXTENSION STUDY WILL START AT VISIT 9/WEEK 12 (FIRST VISIT IN THE EXTENSION) AND WILL CONTINUE FOR AN ADDITIONAL 66 WEEKS UNTIL VISIT 17/WEEK 78. ALL PATIENTS RANDOMIZED IN THE BASE STUDY WHO COMP
BLINDED METFORMIN WILL NOT BE DISPENSED.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
70 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. COMPLETE THE DOUBLE-BLIND BASE STUDY (WITH OR WITHOUT INIATIATION OF GLYCEMIC RESCUE MEDICATION WITH OPEN-LABEL METFORMIN). 2. HAVE ≥ 75% COMPLIANCE WITH DOUBLE-BLIND STUDY MEDICATION DURING THE BASE STUDY DOUBLE-BLIND TREATMENT PERIOD. 3. UNDERSTAND THE EXTENSION STUDY PROCEDURES AND AGREE TO PARTICIPATE IN THE EXTENSION BY GIVING WRITTEN INFORMED CONSENT. 4. WOMEN OF CHILDBEARING POTENTIAL MUST CONTINUE TO COMPLY WITH THE PROTOCOL- SPECIFIED CONTRACEPTIVE METHODS AS PREVIOUSLY OUTLINED IN THE BASE STUDY.
Exclusion criteria
Exclusion criteria: 1. PATIENT HAS A HISTORY OF INTOLERANCE OR ANY CONTRAINDICATION FOR THE USE OF PIOGLITAZONE OR METFORMIN DESCRIBED IN THE PACKAGE INSERT FROM THE COUNTRY OF THE INVESTIGATIONAL SITE. 2. PATIENT MEETS ANY OF THE BASE STUDY CRITERIA FOR DISCONTINUATION FROM THE STUDY DRUG. 3. PATIENT HAS CONGESTIVE HEART FAILURE (NYHA 1-IV). 4. PATIENT REQUIRES OR IS LIKELY TO REQUIRE THERAPY WITH GEMFIBROZIL OR OTHER STRONG CYP2C8 INHIBITORS. 5. PATIENT HAS EXCLUSIONARY LABORATORY VALUES BASED ON THE CENTRAL LAB RESULTS FROM THE LAST VISIT PRIO TO THIS AMENDMENT BEING APPROVED (OR FROM VISIT 7 FOR THOSE PATIENTS NOT ALREADY ENTERED INTO THE EXTENSION) AS LISTED IN TABLE THE 2-1 BELOW. 6. PATIENT HAS BLADDER CANCER OR HAS A HISTORY OF BLADDER CANCER.
Contacts
Public ContactRodolfo Lozano
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed