Type 2 Diabetes mellitus
Conditions
Interventions
Trade Name: JANUVIA
Product Code: MK-0431
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: SITAGLIPTIN PHOSPHATE
CAS Number:
Sponsors
Merck Sharp & Dohme Corp.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At Visit 1/Screening 1. Have T2DM and be =18 years of age 2. Be on one of the following treatment regimens: - Be on stable Met-IR monotherapy 1000 mg/day for =8 weeks with a Visit 1/Screening A1C =7.5% and =11.0% (=58 mmol/mol and =97 mmol/mol). OR – Be on stable Met-XR monotherapy 1000 mg/day for =8 weeks with a Visit 1/Screening A1C =7.5% and =11.0% (=58 mmol/mol and =97 mmol/mol). OR – Not on any AHA for =8 weeks (=12 weeks if previously taking thiazolidinediones) with a Visit 1/Screening A1C =8.5% and =12.0% (=69 mmol/mol and =108 mmol/mol). OR – Be on stable monotherapy with a sulfonylurea, a glinide, or an a-glucosidase inhibitor for =8 weeks with a Visit 1/Screening A1C =7.5% and =11.0% (=58 mmol/mol and =97 mmol/mol). 3. Have a body mass index (BMI) =18.0 kg/m2. At Visit 3 4. Be on stable Met-IR monotherapy 1000 mg/day as described in Section 2.1, Table 1 with a Visit 3 /Week -2 A1C of =7.5% and =11.0% (=58 mmol/mol and =97 mmol/mol) At Visit 4/Day 1 5. Be =80% compliant with the placebo run-in medication (as determined by subject report) 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 380 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: At Visit 1/Screening 1. Has a history of type 1 diabetes mellitus or a history of ketoacidosis or subject is assessed by the investigator as possibly having type 1 diabetes mellitus confirmed with a C-peptide 2 times Upper Limit of Normal (ULN) TSH: Outside central laboratory normal range Hemoglobin: male: 600 mg/dL (6.78 mmol/L) At Visit 3/Week -2 6. Has a clinically significant ECG finding that requires further diagnostic evaluation or intervention 7. Has an FPG consistently (i.e., measurement repeated and confirmed within 7 days) >270 mg/dL (15.0 mmol/L). 8. Has a fasting TG level >600 mg/dL (6.8 mmol/L). At Visit 4/Randomization/Day 1 9. Has a site fasting fingerstick glucose (FFSG) of 270 mg/dL (15.0 mmol/ L). 10. Blood pressure and lipid medication are not at a stable dose for at least 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To assess the effect of up-titration of metformin plus the addition of sitagliptin compared with the up-titration of metformin alone on reduction from baseline in A1C. 2. To assess the overall safety and tolerability of up-titration of metformin plus the addition of sitagliptin compared to up-titration of metformin alone. ; Secondary Objective: 1. To assess the overall safety and tolerability of up-titration of metformin plus the addition of sitagliptin compared to up-titration of metformin alone. 2. To assess the effect of up-titration of metformin plus the addition of sitagliptin compared to up-titration of metformin alone on reduction from baseline in fasting plasma glucose. 3. To assess the proportion of subjects with baseline A1C = 8.5% that are at the A1C goal of <7% (<53 mmol/mol) with up-titration of metformin plus the addition of sitagliptin compared with the up-titration of metformin alone. 4. To assess the proportion of subjects receiving glycemic rescue therapy with up-titration of metformin plus the addition of sitagliptin compared with the up -titration of metformin alone. ;Primary end point(s): A1C – change from baseline at Week 20;Timepoint(s) of evaluation of this end point: Week 20 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of subjects with A1C <7.0% at Week 20 Fasting Plasma Glucose (FPG) – change from baseline at Week 20 ;Timepoint(s) of evaluation of this end point: Week 20 | — |
Countries
Argentina, Brazil, Canada, Czech Republic, Guatemala, Mexico, Russian Federation, United States
Contacts
Public ContactGlobal Clinical Trial Operations
Merck Sharp & Dohme Corp.
Outcome results
None listed