Diabetes Mellitus, Type 2
Conditions
Brief summary
To demonstrate that efficacy of Gosogliptin as Monotherapy and in Combination with Metformin is non-inferior to efficacy of Vildagliptin as Monotherapy and in combination with Metformin in the effects on glycosilated hemoglobin (HbA1c) at Week 12 and Week 36 compared to baseline (Week 0).
Detailed description
* Screening of patients at Week -2 * Training for all complying patients in Diabetes Program School at Week -1 with glucometer and patient diary distribution for SMBG * Randomization in one of two groups in the ratio 1:1. * The 1st stage includes 12 weeks of monotherapy with Gosogliptin or Vildagliptin. * The 2nd stage includes 24 weeks of combination therapy with Gosogliptin and Metformin or Vildagliptin and Metformin. * Follow-up period of 4 weeks.
Interventions
DRUGGosogliptin
20 mg per day, dose titration to 30 mg per day at Week 4 as required Administration: orally
DRUGVildagliptin
50 mg per day, dose titration to 100 mg per day at Week 4 as required (50 mg twice a day) Administration: orally
DRUGMetformin
1000 mg per day starting Week 12 (500 mg twice a day), dose titration to 2000 mg per day at Week 16 as required (1000 mg twice a day). Administration: orally
Sponsors
SatRx LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
No
Inclusion criteria
1. Men and women from 18 through 78 years 2. Confirmed clinical diagnosis of type 2 diabetes mellitus 3. Drug-naive patients or patients without hypoglycemic drug treatment at least till 12 weeks before screening 4. Patient's agreed to use adequate methods of contraception during the study 5. Body mass index 22-40 kg/m2 6. HbA1c 7.5 - 11.0% 7. FPG \< 15 mmol/L 8. Signed informed consent 9. Patient's ability to follow all protocol requirements
Exclusion criteria
1. Pregnancy and lactation, women who plan to become pregnant during the clinical study, women of child-bearing potential (i.e. non-stylized surgically and in period of post menopause less than 2 years) without adequate methods of contraception. 2. History of type 1 diabetes mellitus and other forms 3. Severe metabolic complications of diabetes as ketoacidosis, hyperosmolar coma during 6 weeks before screening 4. Severe complication of diabetes, for instance proliferative retinopathy in active stage, autonomic neuropathy or gastroparesis 5. A known allergy, hypersensitivity or contraindications to Gosogliptin, Vildagliptin, Metformin or their components 6. Convulsive disorder; system autoimmune diseases or vascular collagenosis demanding the previous or current treatment by systemic corticosteroids, cytostatics; malignancy within the last 5 years (except for a basal-cell carcinoma); 7. Significant cardiovascular diseases within 12 months of screening including: chronic heart failure of a class III or IV (NYHA), severe arrhythmia demanding treatment with antiarrhythmics, unstable angina, myocardial infarction, heart and coronary vessels surgery, heart valves diseases, transitory ischaemic attack or stroke, uncontrolled arterial hypertension with systolic Blood Pressure \> 180 mm Hg and diastolic Blood Pressure \> 110 mm Hg, pulmonary embolism or deep venous thrombosis 8. A nephrotic syndrome, a chronic renal failure, serum creatinine \> 1.5 mg/dL (132 µmol/L) in men and \> 1.4 mg/dL (123 µmol/L) in women or GFR \<60 ml/min/1.73m2 9. HBV, HCV or a liver cirrhosis; AST or ALT \> 3 ULN; total bilirubin \> 2 ULN 10. HIV; severe infection that can affect glycemia within 30 days of screening 11. Anemia (Hb ≤10.5 g/dL in women or ≤11.5 g/dL in men); loss of \> 1 unit of blood ( 500 mL) or blood transfusion within 12 weeks of screening 12. Drugs or alcohol abuse 13. Administration of any study drug within 30 days of screening 14. Inability to read or write; unwillingness to understand and follow the protocol procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change of HbA1c | at Weeks 12 and 36 from baseline | Gosogliptin treatment group vs. Vildagliptin treatment group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c level of ≤7% | at Weeks 12 and 36 from baseline | Percent of patients who reach the target HbA1c |
| Hypoglycemic episodes | up to 36 week | Incidence of hypoglycemic episodes during the monotherapy and in combination with Metformin |
| Fasting plasma glucose | at Weeks 12 and 36 | Change of fasting plasma glucose from baseline |
| Change of Body Mass | at Weeks 12 and 36 | Change of Body Mass from baseline |
| Adverse event | up to 40 week | AE rate |
Countries
Russia
Outcome results
None listed