None listed
Conditions
Interventions
THE STUDY WILL BE CONDUCTED IN APPROXIMATELY 60 SITES IN THE UNITED STATES OF AMERICA, MEXICO AND OTHER COUNTRIES IN LATIN AMERICA.
AN ESTIMATED TOTAL OF 200 PATIENTS (100 PER TREATMENT ARM) WILL B
8.0 %.
ALL STUDY DRUGS (ALEGLITAZAR AT A FIXED DOSE OF 150 µG OR MATCHING PLACEBO) WILL BE GIVEN ORALLY ONCE DAILY FOR 26 WEEKS.
THROUGHOUT THE STUDY, PATIENTS WILL CONTINUE ON THEIR EXISTING DO
1500 MG/DAY OR INDIVIDUAL MAXIMALLY TOLERATED DOSE, BUT NOT MORE THAN THE MAXIMUM DOSE SPECIFIED IN THE LABEL). METFORMIN DOSE MAY BE REDUCED IN CASE OF HYPOGLYCEMIA.
AN INDEPENDENT CLINICAL EVENTS
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. MEN AND WOMAN AGED AT LEAST 18 YEARS AT SCREENING. WOMEN OF CHILD-BEARING POTENTIAL USING HIGHLY EFFECTIVE, MEDICALLY APPROVED BIRTH CONTROL METHODS (E.G., HORMONAL CONTRACEPTIVES, IUD, BARIER CONTRACEPTION) MUST BE WILLING TO USE THE SAME METHODS OF CONTRACEPTION DURING THE WHOLE COURSE OF THE STUDY. 2. T2D PATIENTS TREATED WITH STABLE METFORMIN MONOTHERAPY FOR AT LEAST 12 WEEKS PRIOR TO SCREENING. METFORMIN DOSE SHOULD BE ≥ 1500 MG/DAY (OR INDIVIDUAL MAXIMALLY TOLERATED DOSE), BUT NOT MORE THAN THE MAXIMUM DOSE SPECIFIED IN THE LABEL. 3. HbA1c ≥ 7 % AND ≤ 9.5 % AT SCREENING OR WITHIN 4 WEEKS PRIOR TO SCREENING (BY LOCAL LABORATORY) AND AT PRE-RANDOMIZATION VISIT (BY CENTRAL LABORATORY). 4. FPG ≤ 13.3 mmol/L (≤ 240 mg/dL) AT PRE-RANDOMIZATION VISIT (BY CENTRAL LABORATORY). 5. AGREEMENT TO MAINTAIN DIET AND EXERCISE HABITS IMPLEMENTED DURING THE RUN-IN PHASE DURING THE FULL COURSE OF THE STUDY. 6. ABLE AND WILLING TO PROVIDE WRITTEN INFORMED CONSENT AND TO COMPLY WITH THE STUDY PROTOCOL.
Exclusion criteria
Exclusion criteria: 1. WOMEN WHO ARE PREGNANT, INTENDING TO BECOME PREGNANT DURING THE STUDY PERIOD, CURRENTLY LACTATING FENALES, OR WOMEN OF CHILD-BEARING POTENTIAL NOT USING HIGHLY EFFECTIVE, MEDICALLY APPROVED BIRTH CONTROL METHODS. 2. DIAGNOSIS OR HISTIRY OF: A) TYPE DIABETES MELLITUS, DIABETES RESULTING FROM PANCREATIC INJURY, OR SECONDARY FORMS OF DIABETES, E.G., ACROMEGALY OR CUSHING´S SYNDROME. B) ACUTE METABOLIC DIABETIC COMPLICATIONS SUCH AS KETOACIDOSIS OR HYPEROSMOLAR COMA WITHIN THE PAST 6 MONTHS. 3. ANY PREVIOUS TREATMENT WITH A THIAZOLIDINEDIONE OR WITH A DUAL PPAR AGONIST. 4. ANY BODY WEIGHT LOWERING OR LIPROTEIN-MODIFYING THERAPY (E.G., FIBRATES) WITHIN 12 WEEKS PRIOR TO SCREENING WITH THE EXCEPTION OF STABLE (≥ 1 MONTH) STATIN THERAPY. 5. PRIOR INTOLERANCE TO A FIBRATE. 6. TREATMENT WITH ANY ANTI-DIABETIC MEDICATION OTHER THAN METFORMIN IN THE LAST 12 WEEKS PRIOR TO SCREENING AND/OR HERBAL/OVER-THE-COUNTER PREPARATIONS THAT MAY AFFECT GLYCEMIC CONTROL WITHIN 12 WEEKS PRIOR TO SCREENING. 7. TRIGLYCERIDES (FASTING) > 4.5 mmol/L (> 400 mg/dL) AT SCREENING OR WITHIN 4 WEEKS PRIOR TO SCREENING (BY LOCAL LABORATORY). 8. PATIENTS WITH CLINICALLY APPARENT LIVER DISEASE CHARACTERIZED BY EITHER ONE OF THE FOLLOWING: A) ALT OR AST > 3X UPPER LIMIT OF NORMAL (ULN) CONFIRMED ON TWO
Countries
Argentina, Mexico, United States
Contacts
Public ContactJorge Timoteo
PRODUCTOS ROCHE Q.F.S.A.
Outcome results
None listed