Type 2 Diabetes Mellitus (T2DM) MedDRA version: 12.1 Level: LLT Classification code 10067585 Term: Type 2 diabetes mellitus
Conditions
Interventions
Trade Name: JANUVIA
Pharmaceutical Form: Tablet
CAS Number: 654671-78-0
Other descriptive name: SITAGLIPTIN PHOSPHATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
Merck Sharp & Dohme Corp.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At Visit 1 /Screening Visit 1. Patient has T2DM and is =18 and =79 years of age on the day of signing the informed consent form. 2. Patient is on a stable dose of metformin monotherapy at a dose of at least 1500 mg per day for at least 12 weeks and has an A1C =7.0% and =11.0% at Visit 1/ Screening Visit. 3. Patient is a male, or a female who is highly unlikely to conceive as indicated by at least one "yes" answer to the following questions: a. Patient is a female who is not of reproductive potential. A female patient who is not of reproductive potential is defined as one who has either (1) reached natural menopause (defined as =6 months of spontaneous amenorrhea with serum FSH levels in the postmenopausal range as determined by the laboratory, or =12 months of spontaneous amenorrhea in women >45 years of age), or (2) undergone bilateral oophorectomy and/or hysterectomy, or bilateral tubal ligation. b. Patient is of reproductive potential and agrees to remain abstinent (where approved by IRB/ERCs as method of contraception) or use (or have their partner use) an acceptable method of birth control within the projected duration of the study and for 14 days after the last dose of study medication. Acceptable methods of birth control are: hormonal contraceptives, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy. 4. Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving informed written consent. 5. Patient is deemed capable by the investigator of using a liraglutide pen device. 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: At Visit 1/ Screening Visit Glucose Metabolism and Therapy Criteria 1. Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis or patient is assessed by the investigator as possibly having type 1 diabetes mellitus confirmed with a C-peptide 2 drinks per day or >14 drinks per week, or binge drinking. 15. Patient has a history or new evidence of any conditio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: After 26 weeks, in patients with T2DM with inadequate glycemic control on metformin monotherapy: To assess the effect of a sitagliptin-based treatment paradigm compared with a liraglutide-based treatment paradigm on A1C;Secondary Objective: After 26 weeks, to assess the effect of a sitagliptin-based treatment paradigm compared with a liraglutide-based treatment paradigm: 1) on fasting plasma glucose (FPG). 2) on the proportion of patients at the glycemic goals of A1C <7.0% and <6.5%.;Primary end point(s): A1C change from baseline at Week 26 | — |
Countries
Czech Republic, Denmark, Finland, Germany, Hungary, Italy, Lithuania, Poland, Slovakia, Slovenia, Spain, Sweden, United Kingdom
Outcome results
None listed