type II diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Trade Name: JANUVIA
Pharmaceutical Form: Tablet
INN or Proposed INN: Sitagliptin
Current Sponsor code: MK-0431
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with type 2 diabetes 2. Age >= 18 years and = 7.5% and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes 2. Patient has symptomatic hyperglycemia requiring immediate initiation of antihyperglycemic therapy 3. Patient is on a weight loss program and not in the maintenance phase 4. Patient has undergone major surgery within the prior 30 days or has major surgery planned during the study 5. History of intolerance or hypersensitivity or contraindication to use metformin or pioglitazone 6. Patient has received treatment with an investigational drug within the prior 3 months or is participating in another trial 7. Patient has previously been treated with a DPP-4 inhibitor (including sitagliptin) 8. Patient is on or likely to require treatment with immunosuppressive agents 9. Patient is on or likely to require treatment with CYP2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin) 10. Patient is on a weight loss program/medication and not in the maintenance phase 11. Active liver disease or symptomatic gallbladder disease 12. Severe active peripheral vascular disease 13. Congestive heart failure NYHA Class I through IV 14. New or worsening signs of coronary heart disease or CV-event within the past 3 months 15. Patient is HIV positive 16. Significant hematological disorder 17. History of malignancy 18. Patient is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study 19. Patient has a history of drug or alcohol abuse 20. Pregnancy 21. Renal function impairment: Serum-creatinine male >= 1.4 mg/dL (123.2 µmol/L) female >= 1.3 mg/dL (114.4 µmol/L) OR estimated Creatinine Clearance (Cockcroft-Gault) 2 times upper normal limit 23. Patient has a known, clinically significant ECG abnormality or QTc interval > 480 ms 24. At randomization: fasting fingerstick glucose 320 mg/dL (17.8 mmol/L) 25. Patient is under treatment for hyperthyroidism 26. Poorly controlled hypertension (systolic BP = 165 mmHg, diastolic BP = 95 mmHg) 27. Patient is on lipid-modifying medications (or requires initiation of lipid-modifying medications) and will not be on a stable dose for at least 4 weeks prior to Visit 3 28. Patient has active nephropathy or active myopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of the fixed-dose combination (MK-0431A) compared with the effect of pioglitazone 45 mg q.d.on HbA1c at Week 40.;Secondary Objective: Higher portion of patients on the fix dose combo who achieve glycemic goal;Primary end point(s): HbA1c at 40 weeks | — |
Countries
Germany, Greece, Iceland, Italy, Slovenia
Outcome results
None listed