type II Diabetes mellitus MedDRA version: 8.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Product Name: sitagliptin
Product Code: MK-0431
Pharmaceutical Form: Tablet
INN or Proposed INN: sitagliptin
Other descriptive name: MK-0431
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Patient has type 2 diabetes mellitus (T2DM), as indicated by a "yes" to one of the following criteria: (1) Patient was diagnosed with diabetes after age 40 years and insulin therapy was initiated at least 3 years after the diagnosis of diabetes (2) Patient does not meet criteria in a.(1) above (i.e., diagnosis 0.7 ng/mL Note: only patients who do not meet criteria a.(1) should have a C-peptide level measured 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: Glucose Metabolism and Therapy Criteria a. Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis. b. Patient has been treated with a sulfonylurea, meglitinide, alpha glucosidase inhibitor within the past 2 months, or a thiazolidinedione (TZD) PPAR? agent within the past 3 months. c. Patient has been treated with exenatide within the past 3 months. d. Patient is currently on treatment with daily use (one or more injections per day) of a pre-prandial short-acting or rapid-acting insulin (e.g., aspart, glulisine, lispro, or regular insulin). Note: patients using a pre-mixed insulin including a short-acting insulin may participate; patients who occasionally (< 3 times per week) use a short-acting insulin may participate. e. Patient has a history of 2 or more episodes of hypoglycemia resulting in seizure, coma, or loss of consciousness, - or - patient has had recurrent (=3 times per week) episodes of hypoglycemia over the past 8 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In patients with type 2 diabetes mellitus (T2DM) and who have inadequate glycemic control (HbA1c =7.5% and < 11%) on insulin (alone or in combination with metformin): Objective: After 24 weeks, to assess the effect of the addition of treatment with sitagliptin compared with the addition of placebo on HbA1c level. Hypothesis: After 24 weeks, the addition of treatment with sitagliptin compared with placebo results in a greater reduction in HbA1c. Objective: To assess the safety and tolerability of sitagliptin Hypothesis: Sitagliptin is well tolerated.;Primary end point(s): HbA1c ;Secondary Objective: In patients with type 2 diabetes mellitus (T2DM) and who have inadequate glycemic control (HbA1c =7.5% and < 11%) on insulin (alone or in combination with metformin): Objective: After 24 weeks, to assess the effect of the addition of treatment with sitagliptin compared with placebo on (1) HbA1c level in the sub-population of patients on a long-acting or intermediateacting insulin (alone or in combination with metformin). (2) Fasting plasma glucose (FPG) (3) Glycemic response after a meal (e.g., 2-hour post-prandial glucose (PPG) and glucose excursion after a standard meal) (4) In the subset of patients who have a frequently sampled meal tolerance test, parameters describing pancreatic beta-cell function (e.g., static and dynamic glucose sensitivity) (5) The proportion of patients achieving an HbA1c <7.0% (6) The proportion of patients achieving an HbA1c <6.5% (7) Weight | — |
Countries
Austria, Bulgaria, Denmark, Finland, France, Hungary, Ireland, Italy, Portugal
Outcome results
None listed