None listed
Conditions
Interventions
THE DURATION OF THE STUDY WILL BE UP TO 27 WEEKS (WITH 5 CLINIC VISITS). THIS WILL INCLUDE A 1-WEEK SCREENING PERIOD (VISIT 1 TO VISIT 2) AND A 26-WEEK OPEN-IABEL TREATMENT PERIOD (VISIT 2 TO VISIT 5)
1500 MG PER DAY FOR AT LEAST 12 WEEKS), WHO HAVE A HEMOGLOBIN A1C (A1C) ≥
11.0% AND WHO MEET ALL STUDY ENROLLMENT CRITERIA WILL BE ELIGIBLE TO ENTER INTO THE 26-WEEK OPEN-IABEL TREATMENT PERIOD AT VISIT 2/DAY 1. PATIENTS WILL BE RANDOMIZED TO EITHER SITAGLIPTIN OR LIRAGLUTI
1500 MG PER DAY AND DIET/EXERCISE THERAPY THROUGHOUT THE STUDY.
AT VISIT 3/WEEK 12, PATIENTS GLICEMIC STATUS WILL BE ASSESSED BY A MANDATORY SITE-FINGERSTICK A1C AND SITE-FASTING FINGERSTICK GLUCOS
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1. PATIENT HAS T2DM AND IS ≥ 18 AND ≤ 79 YEARS OF AGE ON THE DAY OF SIGNING THE INFORMED CONSENT FORM. 2. PATIENT IS ON A STABLE DOSE OF METFORMIN MONOTHERAPY AT A DOSE OF AT LEAST 1500 MG PER DAY FOR AT LEAST 12 WEEKS AND HAS AN A1C ≥ 7.0% AND ≤ 11.O% AT VISIT 1/SCREENING VISIT. 3. PATIENT IS A MALE, OR A FEMALE WHO LS HIGHLY UNLIKELY TO CONCEIVE AS INDICATED BY AL LEAST ONE YES ANSWER TO THE FOLLOWING QUESTIONS; A. PATIENT IS A FEMALE WHO IS NOT OF REPRODUCTIVE POTENTIAL. A FEMALE PATIENT WHO IS NOT OF REPRODUCTIVE POTENTIAL IS DEFINED AS ONE WHO HAS EITHER (1) REACHED NATURAL MENOPAUSE (DEFINED AS ≥ 6 MONTHS 0F SPONTANEOUS AMENORRHEA WITH SERUM FSH LEVELS IN THE POSTMENOPAUSAL RANGE AS DETERMINED BY THE LABORATORY, OR ≥ 12 MONTHS OF SPONTANEOUS AMENORRHEA IN WOMEN >45 YEARS OF AGE), OR (2) UNDERGONE BILATERAL OOPHORECTOMY AND/OR HYSTERECTOMY OR BILATERAL TUBAL LIGATION. B. PATIENT IS OF REPRODUCTIVE POTENTIAL AND AGREES TO REMAIN ABSTINENT (WHERE APPROVED BY IRB/ERCS AS METHOD OF CONTRACEPTION) OR USE (OR HAVE THEIR PARTNER USE) ACCEPTABLE METHOD OF BIRTH CONTROL WITHIN THE PROJECTED DURATION OF THE STUDY AND FOR 14 DAYS AFTER THE LAST DOSE OF STUDY MEDICATION. ACCEPTABLE METHODS OF BIRTH CONTROL ARE: HORMONAL CONTRACEPTIVES, INTRAUTERINE DEVICE (IUD), DIAPHRAGM WITH SPERMICIDE, CONTRACEPTIVE SPONGE, CONDOM, VASECTOMY. 4. PATIENT UNDERSTANDS THE STUDY PROCEDURES,
Exclusion criteria
Exclusion criteria: AT VISIT 1/SCREENING VISIT GLUCOSE METABOLISM AND THERAPV CRITERIA 1. PATIENT HAS A HISTORY OF TYPE 1 DIABETES MELLITUS OR A HISTORY OF KETOACIDOSIS OR PATIENT IS ASSESSED BY THE INVESTIGATOR AS POSSIBLY HAVING TYPE 1 DIABETES MELLITUS CONFIRMED WITH A C-PEPTIDE <0.7 NG/ML «0.23 NMOL/L). NOTE: ONLY PATIENTS ASSESSED BY THE INVESTIGATOR AS POSSIBLY HAVING TYPE 1 DIABETES MELLITUS SHOULD HAVE C-PEPTIDE MEASURED AT VISIT L/SCREENING VISIT 2. PATIENL HAS BEEN TREATED WITH ANY AHA THERAPIES OTHER THAN METFORMIN MONOTHERAPY WITHIN THE PRIOR 12 WEEKS OF VISIT 1/ SCREENING VISIT. NOTE: PATIENTS WHO HAVE RECEIVED A BRIEF PERIOD OF INSULIN TREATMENT (SUCH AS A FEW DAYS DURING A HOSPITALIZATION) AND WHO NO LONGER REQUIRE INSULIN TREATMENT MAY PARTICIPATE. PATIENTS REQUIRING SPECIFIC TREATRNENTS 3. PATIENT IS CURRENTLY PARTICIPATING IN OR HAS PARTICIPATED IN ANOTHER STUDY WITH AN INVESTIGATIONAL COMPOUND 0R DEVICE WITHIN THE PRIOR 12 WEEKS OF SIGNING THE INFORMED CONSENT OR DOES NOT AGREE TO REFRAIN FROM PARTICIPATING IN ANY OTHER STUDY WHILE PARTICIPATING IN THIS STUDY. 4. PATIENT HAS A HISTORY OF HYPERSENSITIVITY OR ANY CONTRAINDICATION TO SITAGLIPTIN, LIRAGLUTIDE, GLIMEPIRIDE, OR METFORMIN BASED UPON THE LABELS OF THE COUNTRY OF THE INVESTIGATIONAL SITE.
Contacts
Public ContactJorge Timoteo
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed