Type 2 Diabetes Mellitus MedDRA version: 20.0 Level: LLT Classification code 10012594 Term: Diabetes System Organ Class: 100000019275
Conditions
Interventions
Trade Name: JANUVIA
Product Name: Januvia
Product Code: MK-0431
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Sitagliptin
CAS Number: 654671-78-0
Current Sponsor code: MK-0431
Other des
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible for participation in this trial, the subject must: (1) have T2DM and be =25 years of age on the day of signing ICF; (2) have an eGFR =60 mL/min/1.73m2 and =65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: The subject must be excluded from participating in the trial if the subject: (1) has a history of T1DM or ketoacidosis; (2) has history of secondary causes of diabetes; (3) has known hypersensitivity or intolerance to any DPP-4 inhibitor or SGLT2 inhibitor; (4) has been treated with prohibited agents (as listed in the protocol) within 12 weeks of Visit 1/Screening; (5) is not weight stable; (6) is at high risk for volume depletion, hypotension and/or electrolyte imbalances, in the opinion of the investigator; (7) is on or likely to require treatment for =7 consecutive days with non-steroidal anti-inflammatory drugs; (8) is pregnant or breast-feeding; (9) has an exclusionary laboratory value as listed in the protocol; (10) has participated in other studies involving investigational drugs within 30 days prior to Visit 1/Screening or during the pre-randomization period; (11) has FPG consistently >260 mg/dL (14.4. mmol/mol).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: After 24 weeks, to assess the effect of the addition of sitagliptin compared with the addition of dapagliflozin on A1C and the overall safety and tolerability of sitagliptin in comparison to that of dapagliflozin.;Secondary Objective: After 24 weeks, to assess the effect of the addition of sitagliptin compared with the addition of dapagliflozin on change from baseline in 2-hr incremental post-prandial glucose excursion and change from baseline in 2-hr post-prandial glucose. To assess, in a subset of subjects, the effect of the addition of sitagliptin compared with that of dapagliflozin on change from baseline in post-prandial insulin AUC, glucagon AUC, and insulin AUC: glucagon AUC ratio. To assess the effect of the addition of sitagliptin compared with that of dapagliflozin on the proportion of subjects at the A1C goal of <7%. To describe the effect of the addition of sitagliptin compared with that of dapagliflozin on change in fasting plasma glucose (FPG) from baseline.;Primary end point(s): Change from baseline in A1C;Timepoint(s) of evaluation of this end point: 24 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) Change from baseline in 2-hr incremental post-prandial glucose excursion; (2) change from baseline in 2-hr post-prandial glucose (PPG); (3) change from baseline in post-prandial insulin AUC, glucagon AUC, and insulin AUC:glucagon AUC ratio; (4) proportion of subjects at the A1C goal of <7.0% (<53 mmol/mol); (5) change in fasting plasma glucose (FPG) from baseline.;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Countries
Argentina, Australia, Brazil, Canada, Colombia, Estonia, Finland, Germany, Hungary, Ireland, Korea, Republic of, Latvia, Lithuania, Mexico, New Zealand, Norway, Peru, Puerto Rico, Romania, Russian Federation, South Africa, Spain, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Trials Operations
Merck Sharp & Dohme, UAB
Outcome results
None listed