Obesity in patients with type 2 diabetes mellitus MedDRA version: 8.1 Level: LLT Classification code 10029883 Term: Obesity
Conditions
Interventions
Product Name: MK-0364
Product Code: MK-0364
Pharmaceutical Form: Capsule, soft
Current Sponsor code: MK-0364
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Sponsors
Merck & Co. Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men (minimum 25%; targeting 40%) and women with a body mass index (BMI) between 27 kg/m2 and 43 kg/m2, inclusive. 2. Patients =18 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient has a history of type 1 diabetes mellitus [confirmed with a C-peptide <0.8 ng/mL (0.26 nmol/L)] or a history of ketoacidosis. 2. Patient has a history or presence of a major psychiatric disorder including, but not limited to schizophrenia or other psychotic disorders, major depression, bipolar disorder, generalized anxiety disorder, personality disorder or eating disorder (e.g. bulimia, anorexia disorder). 3. Patient has a history of seizures or is at high risk of developing seizures (e.g., those with history of brain tumors or severe head trauma or intracranial hemorrhage). 4. Patient currently uses or is likely to require long term use of any prescription or nonprescription medication that is a potent or moderate inhibitor of CYP3A4, or currently uses or plans to use any medication in the medication exclusion list
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To assess the effects of MK-0364 on body weight after 36 weeks of treatment. 2. To assess the effects of MK-0364 on hemoglobin A1c (HbA1c) after 36 weeks of treatment. 3. To assess the safety and tolerability of MK-0364. ;Secondary Objective: To assess the effects of treatment with MK-0364 0.5-, 1- or 2-mg on: 1. body weight after 24 and 52 weeks. 2. hemoglobin A1c (HbA1c) after 24 and 52 weeks. 3. FPG, insulin and insulin sensitivity after 24, 36, and 52 weeks. 4. biochemical markers (TG, HDL-C, non-HDL-C, LDL-C, TC, adiponectin and CRP) after 24, 36, and 52 weeks. 5. body weight and HbA1c in subgroups of patients not on anti-hyperglycemic therapy or on metformin monotherapy at randomization. 6. waist circumference after 24, 36, and 52 weeks. 7. blood pressure after 24, 36, and 52 weeks. 8. the proportion of patients requiring glycemic rescue therapy after 24, 36 weeks and 52 weeks. 9. Quality-of-life and health economic patient-reported outcomes (PRO) after 24, 36 and 52 weeks.;Primary end point(s): Body weight and HbA1c. | — |
Countries
Germany, Lithuania, Sweden
Outcome results
None listed