None listed
Conditions
Interventions
THE DURATION OF THE STUDY WILL BE TO 29 WEEKS (WITH 9 CLINIC VISITS) FOR EACH PATIENT. THIS WILL INCLUDE A 1 WEEK SCREENING PERIOD (VISIT 1/SCREENING VISIT TO VISIT 2)
AN INSULIN SWITCH (FOR PATIENTS NOT ON INSULIN GLARGINE ONCE-DAILY IN THE EVENING) AND SULFONYLUREA “WASH-OFF” (FOR PATIENTS ON SULFONYLUREA) PERIOD OF 2 WEEKS (VISIT 2 TO VISIT 3 /WEEK-2)
A 2 WEEK SINGLE-BLIND PLACEBO RUN IN PERIOD (VISIT 3/ WEEK -2 TO VISIT 4/DAY 1), AND A 24-WEEK DOUBLE BLIND TREATMENT PERIOD (VISIT 4/DAY 1 TO VISIT 9/WEEK 24). PATIENTS WITH T2DM ON A STABLE DOSE OF
1500 MG/DAY AT VISIT 1 / SCREENUNG VISIT AND WHO MEET ALL OTHER ENROLLMENT CRITERIA WILL DIRECTLY ENTER INTO THE 2-WEEK SINGLE BLIND PLACEBO RUN-IN PERIOD AT A COMBINED VISIT 2/3 (SINCE THESE PATIENTS
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Sex/Gender
All
Age
80 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. PATIENT HAS TYPE 2 DIABETES MELLITUS (T2DM). 2. PATIENT MEETS ONE OF THE FOLLOWING CRITERIA: A. PATIENT WAS DIAGNOSED WITH DIABETES AFTER AGE 40 YEARS AND INSULIN THERAPY WAS INITIATED AT LEAST 3 YEARS AFTER THE DIAGNOSIS OF DIABETES, OR -. B. PATIENT DOES NOT MEET THE CRITERIA IN (A) ABOVE (I.E., DIAGNOSIS 0.7 NG/ML. NOTE: ONLY PATIENTS WHO DO NOT MEET THE CRITERIA IN (A) SHOULD HAVE A C-PEPTIDE LEVEL MEASURED. 3. PATIENT MUST BE ≥ 18 AND ≤ 80 YEARS OF AGE ON THE DAY OF SIGNING INFORMED CONSENT. 4. PATIENT IS ON A STABLE INSULIN REGIMEN FOR ≥ 10 WEEKS ± METFORMIN (IMMEDIATE-RELEASE OR EXTENDED-RELEASE FORMULATION) AT ≥ 1500 MG/DAY FOR ≥ 1O WEEKS ± SULFONYLUREA FOR ≥ 1O WEEKS, WITH ONE OF THE FOLLOWING INSULINS (AT A DOSE OF AT LEAST 15 U/DAY AND A MAXIMUM DOSE OF 150 U/DAY) AND HAS A VISIT 1/SCREENING VISIT A1C ≥ 7.5 % AND ≤ 11.0 % (FOR PATIENTS NOT ON SULFONYLUREA) OR A1C ≥ 7.0% AND ≤ 10.0% (FOR PATIENTS ON SULFONYLUREA):
Exclusion criteria
Exclusion criteria: 1. PATIENT HAS BEEN TREATED WITH A DPP-4 INHIBITOR, A THIAZOLIDINEDIONE (TZO), OR A GLP-1 MIMETIC OR ANALOGUE, WITHIN THE PRIOR 12 WEEKS. 2. PATIENT IS CURRENTLY ON TREATMENT WITH DAILY USE (ONE OR MORE INJECTIONS PER DAY) OF A PRE-PRANDIAL SHORT-ACTING OR RAPID-ACTING INSULIN (E.G., ASPART, GLULISINE, LISPRO, REGULAR INSULIN) ALONE OR AS PART OF A BASAL/BOLUS INSULIN REGIMEN. NOTE: PATIENTS USING A PRE-MIXED INSULIN CONTAINING A SHORT-ACTING INSULIN MAY PARTICIPATE. 3. PATIENT HAS SYMPTOMATIC HYPERGLYCEMIA THAT, IN THE INVESTIGATOR´S OPINION, REQUIRES IMMEDIATE INITIATION, ADJUSTMENT, OR ADDITION OF ANTIHYPERGLYCEMIC THERAPY. 4. PATIENT HAS A HISTORY OF 2 OR MORE EPISODES OF HYPOGLYCEMIA RESULTING IN SEIZURE, COMA, OR LOSS OF CONSCIOUSNESS, - OR - PATIENT HAS HAD RECURRENT (≥ 3 TIMES PER WEEK) EPISODES OF HYPOGLYCEMIA OVER THE PAST 8 WEEKS. 5. PATIENT HAS A HISTORY OF KETOACIDOSIS.
Countries
Peru
Contacts
Public ContactRodolfo Hernan Lozano
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed