None listed
Conditions
Interventions
Group 1 Type of group
Placebo for 52 weeks
Group name:Group 4 Type of group
2 mg of taranabant by mouth for 52 weeks
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient has T2DM. • The patient has a body mass index (BMI) (see Appendix 6.1) between 27 kg / m2 and 43 kg / m2, inclusive. • The patient is a male or female person and is> 18 and 1500 mg / day, unless the maximum tolerated dose is 7.0% and 43 years of age and 1) absence of menstruation for> 1 year but <3 years and confirmed by elevated FSH levels to the postmenopausal range (as defined by the designated Clinical Laboratory) or 2) absence of menstruation for at least 3 years. d. The patient has reproductive capacity and agrees to practice abstinence or use (or have their partner use) 2 acceptable methods of birth control during the entire study that begins with Visit 1 (Week -3) and for 28 days after the last dose of the study drug. • The patient understands the study procedures, alternative treatments available and the risks involved in the study, and voluntarily agrees to participate in the study by giving written informed consent. • The patient is able to read, understand and complete the questionnaires and journals of the study.
Exclusion criteria
Exclusion criteria: • The patient has a history of diabetes mellitus type 1 confirmed with a peptide C 160 mm Hg or diastolic blood pressure> 100 mm Hg. • The patient has a recent diagnosis / episode / recurrence (within 6 months prior to signing the informed consent) of stroke, TIA or neurological disorder. • The patient has a history of seizures or is at high risk of developing seizures (for example: patients with a history of brain tumors or severe head trauma or intracranial hemorrhage). • The patient has a history of malignancy 5 years without documentation of remission / cure. Exception: Basal cell skin or squamous cell cancer or cervical cancer of the uterus properly treated. Melanoma, leukemia, lymphoma and myeloproliferative disorders of any duration are excluded. • The patient has undergone a surgical procedure within 1 month prior to signing the informed consent or plans to undergo a surgical procedure during the study. Exception: Patients with a history of minor surgery (for example, with the use of local anesthesia) within 1 month prior to signing the informed consent and who are fully recovered may participate. • The patient has undergone surgical treatment for obesity. Exception: The procedure to which the patient was subjected occurred at least 5 years before the signing of the informed consent and there is no clinical evidence of complications, including, without limitation, malabsorption. • The patient has an endocrinopathy, which will influence the endpoints of the study. The excluded endccrinopathies include, without limitation, hypothyroidism, hyperthyroidism, hypothalamic-pituitary disease and adrenal disease. Exceptions: Patients with endocrinopathies, which are unlikely to have an impact on the end points of the study, can be included if they meet other criteria of the study. Examples include, without limitation, polycystic ovary syndrome, patients with permanently treated hyperthyroidism (with surgery or radioactive iodine), or patients with hypothyroidism under a stable dose of thyroid hormone replacement therapy for at least 6
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The change in body weight will be evaluated as the average change in body weight and the proportions of patients losing 10% of their basal body weight. HbA1c will be evaluated primarily as the average change in HbA1c Measure:Body weight and HbA1c variation Timepoints:Week 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of the circumference of the waist Measure:Changeof the circumference of the waist Timepoints:After treatment ; Outcome name:Measurement of insulin sensitivity, fasting lipid profile, blood pressure, adiponectin, C-reactive protein Measure:Variation in insulin sensitivity, fasting lipid profile, blood pressure, adiponectin, C-reactive protein Timepoints:After treatment ; Outcome name:include: laboratory measurements, vital signs, ECG and adverse events. The number of patients exceeding the predefined limits of change in the key safety parameters will be evaluated. Measure:Safety and Tolerability Timepoints:After treatment | — |
Contacts
Public ContactSTELA Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed