Type 2 Diabetes Mellitus (T2DM)
Conditions
Interventions
Trade Name: Januvia
Product Code: MK-0431
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Sitagliptin Phosphate
Current Sponsor code: MK-0431
Concentration unit: mg milligram(s)
Concentra
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 > or = 18 years of age on the day of signing ICF; (2) be on one of the following treatment regimens: (a) stable dose of sitagliptin (100 mg/day) and metformin IR or XR (> or = 1500 mg/day) either co-administered or as a FDC for > or = 12 weeks with A1C between 7.5% and 11.0%, inclusive; (b) stable dose of metformin IR or XR (> or = 1500 mg/day) and another DPP-4 inhibitor (at maximum labeled dose), other than sitagliptin, either co-administered or as a FDC, for > or = 12 weeks with A1C between 7.5% and 11.0%, inclusive; (c) stable dose of sitagliptin (100 mg/day) and metformin IR or XR (> or = 1500 mg/day) either co-administered or as a FDC, and a sulfonylurea for > or = 12 weeks OR stable dose of metformin IR or XR (> or = 1500 mg/day) and a sulfonylurea administered as a FDC and sitagliptin (100 mg/day) with A1C between 7.0% and 10.0%, inclusive; (d) stable dose of metformin IR or XR (> or = 1500 mg/day) and another DPP-4 inhibitor (at maximum labeled dose), other than sitagliptin, either co-administered or as a FDC, and a sulfonylurea for > or = 12 weeks OR stable dose of metformin IR or XR (> or = 1500 mg/day) and a sulfonylurea administered as a FDC and another DPP-4 inhibitor other than sitagliptin with A1C between 7.0% and 10.0%, inclusive; (e) stable dose of metformin IR or XR (> or = 1500 mg/day) and a sulfonylurea either co-administered or as a FDC for > or = 12 weeks with A1C between 7.5% and 11.0% (> or = 58 mmol/mol and =65 years) yes F.1.3.1 Number of subjects for this age range 140
Exclusion criteria
Exclusion criteria: The subject must be excluded from participating in the trial if the subject: (1) has been treated with any AHA other than protocol-specified agents (i.e., other than metformin, DPP-4 inhibitor, or sulfonylurea agent) within the prior 12 weeks; (2) has a history of 2 or more episodes of hypoglycemia resulting in seizure, coma, or loss of consciousness, OR subject has had recurrent (> or = 3 times per week) episodes of hypoglycemia over the past 8 weeks; (3) has a history of type 1 diabetes mellitus (T1DM) or ketoacidosis, or has a history of latent autoimmune diabetes of adults (LADA), or subject is assessed by the investigator as possibly having T1DM or LADA confirmed with a C-peptide 270 mg/dL (15.0 mmol/L).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In subjects with T2DM with inadequate glycemic control on metformin and sitagliptin, who initiate and titrate insulin glargine (LANTUS®), to assess the effect of continuing sitagliptin relative to withdrawing sitagliptin on: (1) HbA1c (A1C) after 30 weeks; (2) the event rate of documented symptomatic hypoglycemia with blood glucose < or = 70 mg/dL (< or = 3.9 mmol/L) over 30 weeks; (3) general safety and tolerability over 30 weeks.;Secondary Objective: In subjects with T2DM with inadequate glycemic control on metformin and sitagliptin, who initiate and titrate insulin glargine (LANTUS®), to assess the effect of continuing sitagliptin relative to withdrawing sitagliptin on: 1) the incidence of the following over 30 weeks: a) documented symptomatic hypoglycemia with blood glucose (BG) < or =70 mg/dL; b) documented hypoglycemia with BG < or =70 mg/dL; c) documented symptomatic hypoglycemia with BG <56 mg/dL; d) documented hypoglycemia with BG <56 mg/dL; 2) the event rate of the following over 30 weeks: a) documented symptomatic hypoglycemia with BG <56 mg/dL; b) documented hypoglycemia with BG < or =70 mg/dL ; c) documented hypoglycemia with BG <56 mg/dL; 3) the daily dose of insulin after 30 weeks; 4) the proportion of subjects with A1C <7.0% after 30 weeks; 5) the proportion of subjects with A1C <7.0% after 30 weeks without any event of documented hypoglycemia with BG < or =70 mg/dL ; 6) fasting plasma glucose after 30 weeks.;Primary end point(s): (1) Change from baseline in A1C at Week 30; (2) Event rate of documented symptomatic hypoglycemia with blood glucose < or = 70 mg/dL (< or = 3.9 mmol/L) over 30 weeks.;Timepoint(s) of evaluation of this end point: 30 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Event rate of documented symptomatic hypoglycemia with blood glucose <56 mg/dL (< or = 3.1 mmol/L) over 30 weeks; (2) Incidence of each of the following over 30 weeks: (a) documented symptomatic hypoglycemia with blood glucose < or = 70 mg/dL (< or = 3.9 mmol/L); (b) documented hypoglycemia with blood glucose < or = 70 mg/dL (< or = 3.9 mmol/L); (c) documented symptomatic hypoglycemia with blood glucose <56 mg/dL (< or = 3.1 mmol/L); (d) documented hypoglycemia with blood glucose <56 mg/dL (< or = 3.1 mmol/L); (3) Change from baseline in total daily insulin dose at Week 30; (4) Event rate of each of the following over 30 weeks: (a) documented hypoglycemia with blood glucose < or = 70 mg/dL (< or = 3.9 mmol/L); (b) documented hypoglycemia with blood glucose <56 mg/dL (< or = 3.1 mmol/L); (5) Proportion of subjects at A1C goal <7.0% (<53 mmol/mol) at Week 30; (6) Proportion of subjects at A1C goal <7.0% (<53 mmol/mol) at Week 30 with no documented hypoglycemia with blood glucose < or = 70 mg/dL (< or = 3.9 mmol/L); (7) Change from baseline in FPG at Week 30.;Timepoint(s) of evaluation of this end point: 30 weeks | — |
Countries
Australia, Canada, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Israel, Korea, Republic of, Latvia, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Spain, Turkey, United States
Contacts
Public ContactGlobal Clinical Trials Operations
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
Outcome results
None listed