None listed
Conditions
Interventions
50 mg L-000224715 Type of group
It is a 40-week extension for the double-blind, randomized study. 50 mg of L-000224715 will be administered.
Group name:5 mg de L-000224715. Type of group
It is a 40-week extension for the double-blind, randomized study. 5 mg of L-000224715 will be administered.
Sponsors
MERCK & CO.INC.,
Eligibility
Inclusion criteria
Inclusion criteria: a. Complete the double-blind baseline study. b. They show a compliance of the study medication> 75% during the double-blind treatment period of the baseline study. c. They understand the procedures of the extension study and agree to participate in the extension by providing a written informed consent. d. The patient is a man or a woman who is not pregnant. Potentially fertile women should continue to comply with the use of specified contraceptive methods, as indicated above in the baseline study.
Exclusion criteria
Exclusion criteria: The patient presents a condition or is receiving a therapy that, in his opinion of the investigator, could represent a risk to the patient, or be a factor that causes that its participation is not convenient for him.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Laboratory safety studies will be performed routinely, as specified in the Flowchart of the study. Measure:To evaluate the safety and tolerability of L-000224715 in patients with type 2 diabetes who have inadequate glycemic control. Timepoints:2 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The efficacy endpoints will include HbA1c, FPG, and blood glucose self-monitoring data by fingerstick (SBGM). The FPG will be obtained at each visit. Patients will be asked to obtain 7 point digital puncture measurements before each study visit. Measure:Long-term efficacy of L-000224715 in the decrease of hemoglobin A1c (HbA1c). Timepoints:2 weeks | — |
Countries
Peru, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed