Diabetes Mellitus tipo 2 Type 2 diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10053247 Term: Insulin-requiring type 2 diabetes mellitus
Conditions
Interventions
Trade Name: JANUVIA 100 mg, comprimidos recubiertos con película
Pharmaceutical Form: Tablet
INN or Proposed INN: SITAGLIPTINA FOSFATO MONOHIDRATO
Other
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient has type 2 diabetes and is at least 18 years of age and no older than 78 years of age --Patient is male or is a female who is unlikely to conceive children --Patient is on stable doses of a PPARg agonist and metformin OR metformin and a sulfonylurea agent 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: Patient has Type 1 diabetes --Patient has taken a DPP-4 inhibitor or a GLP-1 analogue --Patient is on a weight loss program that is not in the maintenance phase or has started a weight loss medication within 8 weeks of screening --Patient has had surgery within 30 days of screening or has major surgery planned during the study --Patient is on or is likely to require treatment with corticosteroids for more than 2 weeks --Patient has a history of active liver disease, including hepatitis B or C, cirrhosis, or gallbladder disease --Patient is HIV positive --Patient has congestive heart failure, or has had new or worsening symptoms of coronary heart disease within 3 months prior to screening --Patient has had acute coronary syndrome, coronary artery intervention, or stroke within 3 months of screening --Patient has severe active peripheral vascular disease --Patient has a history of cancer or blood disorder --Patient is pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the 24-hour weighted mean glucose (WMG)-lowering efficacy, safety and tolerability of MK-3577;Secondary Objective: To assess the effect of morning and/or evening administration of MK-3577 on fasting glucose levels, 2-hour postprandial glucose levels after the morning meal and LDL-C; Primary end point(s): Efficacy: A1C Safety and tolerability: Assessed by a review of all safety parameters including adverse experiences, laboratory safety parameters, body weight, and vital signs. | — |
Countries
Italy, Spain
Outcome results
None listed