Patients with T2DM already treated with metformin. MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Trade Name: JANUVIA®
Product Name: JANUVIA®
Product Code: MK 0431
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: sitagliptin
Current Sponsor code: MK-0431
Concentration unit: mg milligra
Sponsors
Laboratoires Merck Sharp & Dohme - Chibret
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At Visit 1 : - Man or woman aged > or equal to 18 - With type 2 diabetes and treated with the maximal tolerated dose of metformin - With documented or high likely inadequate control of diabetes (6.5-9%) - Man, postmenauposal woman or premenopausal woman that is surgically sterilized or a woman who is considered “highly unlikely to conceive” during the study due to use of an acceptable method of birth control At Visit 2 : - Liver transaminases (ALT, AST) 60 ml/min using the Cockcroft-Gault formula (contraindication to metformin). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: At Visit 1 : - Known hypersensitivity or contraindication to metformin - Hypoglycemia unawareness or recurrent major hypoglycemia or history of acidoketosis - Known hypersensitivity to one of the inactive ingredients of sitagliptin tablet - Pregnant or lactating women. - Treatment with any other investigational drug within the last 8 weeks. - Any known contra-indication to physical exercise (walking) according to the investigator - Patient who is known HIV positive - Any medication which is contra-indicated with metformin (according to the current summary characteristics of the product). At Visit 2 : - Any oral glucose-lowering agent other than metformin or change in the metformin dose since the blood sample withdrawn for central laboratory determination. - Insulin injection since the blood sample for central laboratory determination. - Patients treated with immunosuppressive/immunomodulating agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: After addition of Sitagliptin (JANUVIA®) to outpatients with T2DM who have inadequate glycemic control on metformin therapy - To compare the efficacy of three strategies of lifestyle changes associated with JANUVIA 100 mg/d in patients with T2DM inadequately controlled by metformin (HbA1C 6.5-9%). There will be a difference between the three strategies of lifestyle changes.;Secondary Objective: - To estimate the percentage of patients achieving the HbA1c target goal after 24 weeks in each intervention arm and overall - To compare the percentage of patients achieving the HbA1c target goal after 24 weeks between the 3 intervention arms - To estimate the feasibility of pedometer use - To compare the changes in blood parameters between the 3 intervention arms - To confirm the good safety and tolerability of sitagliptin. ;Primary end point(s): HbA1c | — |
Countries
France
Outcome results
None listed