Diabetes Mellitus type 2 MedDRA version: 12.1 Level: LLT Classification code 10067585 Term: Type 2 diabetes mellitus
Conditions
Interventions
Trade Name: Januvia
Product Code: MK-0431
Pharmaceutical Form: Tablet
INN or Proposed INN: sitagliptin phosphate
CAS Number: 654671-77-9
Current Sponsor code: MK-0431
Other descriptive name: Januvia
C
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Visit 1 - Patient has T2DM and is =18 and =78 years of age. - Patient is a male, female who is not of reproductive potential, or patient is female of reproductive potential and agrees to remain abstinent or use an acceptable method of birth control during the study. - Patient is currently taking a stable dose for =10 weeks prior to Visit 1/Screening Visit of either glimepiride (=2mg q.d.) or gliclazide (=50% of the maximum registered dose) AND metformin (=1500mg/day). - Patient has a Visit 1/Screening Visit site-fingerstick A1C =7.0% and =11.0%. Visit 2 - Patient has a central laboratory A1C =7.5% and =10.5%. Visit 4 - Patient has =85% compliance with placebo treatment during single-blind run-in period. 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: Visit 1 - Patient has a history of type 1 diabetes mellitus, ketoacidosis, or is assessed as having type 1 diabetes. Visit 2 - Patient has ever been treatment with a DPP-4 inhibitor or a GLP-1 mimetic OR has required insulin therapy within 12 weeks of signing the informed consent. - Patient is likely to require treatment with =14 consecutive days or repeated courses of pharmacologic doses of corticosteroids. - Patient has a history of active liver disease. - Patient is HIV positive. - Patient has NYHA Class I-IV congestive heart failure, new or worsening symptoms of coronary heart disease or congestive heart failure with the past 3 months. - Patient has poorly controlled hypertension (systolic =160 mm Hg or diastolic =90 mm Hg) - Patient has active peripheral vascular disease. - Patient has history of malignancy or clinically important haematological disorder. - Patient has an exclusionary laboratory value (as listed in protocol Table 2-1). - Patient has a positive urine pregnancy test. Visit 3 - Patient has a clinically significant laboratory or ECG abnormality. Visit 4 - Patient has a positive urine pregnancy test. - Patient has a site-fasting-fingerstick glucose (FFSG) 270 mg/dL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) After 24 weeks, to assess the effect of the addition of treatment with sitagliptin on A1C compared with the addition of placebo; 2) To assess the safety and tolerability of the addition of sitagliptin compared with the addition of placebo.;Secondary Objective: 1) After 24 weeks, to assess the effect of the addition of treatment with sitagliptin on 2-hour post-meal glucose (PMG) (following a standard meal) compared with the addition of placebo; 2) After 24 weeks, to assess the effect of the addition of treatment with sitagliptin on fasting plasma glucose (FPG) compared with the addition of placebo; 3) After 24 weeks to assess the proportion of patients requiring rescue therapy with the addition of treatment with sitagliptin compared with the addition of placebo; 4) After 54 weeks, to assess the effect of the addition of treatment with sitagliptin on A1C; 5) After 54 weeks, to assess the effect of the addition of treatment with sitagliptin on 2-hour PMG; 6) After 54 weeks, to assess the effect of the addition of treatment with sitagliptin on FPG.;Primary end point(s): A1C – change from baseline at Week 24 | — |
Countries
Hungary
Outcome results
None listed