Efficacy and Safety of Gosogliptin as Monotherapy and in Combination With Metformin vs. Vildagliptin as Monotherapy and in Combination With Metformin in Drug-naive Type 2 Diabetic Patients.
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT03088670
- Lead Sponsor
- SatRx LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 299
- Men and women from 18 through 78 years
- Confirmed clinical diagnosis of type 2 diabetes mellitus
- Drug-naive patients or patients without hypoglycemic drug treatment at least till 12 weeks before screening
- Patient's agreed to use adequate methods of contraception during the study
- Body mass index 22-40 kg/m2
- HbA1c 7.5 - 11.0%
- FPG < 15 mmol/L
- Signed informed consent
- Patient's ability to follow all protocol requirements
- 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.
- History of type 1 diabetes mellitus and other forms
- Severe metabolic complications of diabetes as ketoacidosis, hyperosmolar coma during 6 weeks before screening
- Severe complication of diabetes, for instance proliferative retinopathy in active stage, autonomic neuropathy or gastroparesis
- A known allergy, hypersensitivity or contraindications to Gosogliptin, Vildagliptin, Metformin or their components
- 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);
- 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
- 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
- HBV, HCV or a liver cirrhosis; AST or ALT > 3 ULN; total bilirubin > 2 ULN
- HIV; severe infection that can affect glycemia within 30 days of screening
- 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
- Drugs or alcohol abuse
- Administration of any study drug within 30 days of screening
- Inability to read or write; unwillingness to understand and follow the protocol procedures
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gosogliptin treatment group Gosogliptin 12 weeks of monotherapy and 24 weeks of combination with Metformin Gosogliptin treatment group Metformin 12 weeks of monotherapy and 24 weeks of combination with Metformin Vildagliptin treatment group Metformin 12 weeks of monotherapy and 24 weeks of combination with Metformin Vildagliptin treatment group Vildagliptin 12 weeks of monotherapy and 24 weeks of combination with Metformin
- Primary Outcome Measures
Name Time Method Mean change of HbA1c at Weeks 12 and 36 from baseline Gosogliptin treatment group vs. Vildagliptin treatment group
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (27)
State Budget Educational Institution higher professional education "Saratov State Medical University n.a. V.I. Razumovsky" of the Ministry of Healthcare of Russian Federation based on Clinical Hospital n.a S.R. Mirotvortsev
🇷🇺Saratov, Russian Federation
State Educational Institution of Higher Professional Education "Perm State Medical Academy n.a. academician EA Wagner's "Ministry of Health of the Russian Federation on the basis of Department of Endocrinology Regional Clinical Hospital
🇷🇺Perm, Russian Federation
State Health Care Institution Leningrad Regional Hospital
🇷🇺Saint Petersburg, Russian Federation
Autonomous Noncommercial Organization "Medical Centre "XXI сentury"
🇷🇺Saint Petersburg, Russian Federation
State budgetary institution "Nizhny Novgorod Regional Clinical Hospital n.a Semashko
🇷🇺Nizhny Novgorod, Russian Federation
SHI "Republic Hospital n.a. V.A. Baranov"
🇷🇺Petrozavodsk, Russian Federation
FSMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the Ministry of Defence of the Russian Federation, 1st Internal medicine Chair of advanced training
🇷🇺Saint Petersburg, Russian Federation
SBEI HPE "Smolensk State Medical Academy" of the Ministry of Health and Social Development of the Russian Federation, Center of clinical research of diagnostic and medicinal products, Chair of clinical pharmacology
🇷🇺Smolensk, Russian Federation
State autonomous healthcare institution of Yaroslavl Region "Сlinical hospital for emergency medical care n. a. N.V. Solovyov"
🇷🇺Yaroslavl, Russian Federation
State Budget Educational Institution higher professional education "1st Moscow State Medical University n.a. I.M. Sechenov of the Ministry of Healthcare of Russian Federation"
🇷🇺Moscow, Russian Federation
Non-state healthcare Organization "Road Clinical Hospital at the station Chelyabinsk Open Joint Stock Company" Russian Railways
🇷🇺Chelyabinsk, Russian Federation
State budgetary institution of Ryazan region "City Clinical Hospital № 11"
🇷🇺Ryazan, Russian Federation
Federal State Institution "Clinical Hospital № 1" of the Office of the President of the Russian Federation
🇷🇺Moscow, Russian Federation
State Budget Healthcare Institution of Moscow "Endocrinology Dispensary"
🇷🇺Moscow, Russian Federation
SEI HPE "First Moscow State Medical University n.a. I.M. Sechenov of Ministry of Health and Social Development of the Russian Federation", Chair of faculty therapy #2 based at SHI of Moscow "City clinical hospital #61"
🇷🇺Moscow, Russian Federation
State Budget Healthcare Institution of Moscow city "City Clinical Hospital # 71 by the Department of Healthcare in Moscow"
🇷🇺Moscow, Russian Federation
State Health Care Institution "Perm Regional Hospital for War Veterans"
🇷🇺Perm, Russian Federation
SEI APE "Russian Medical Academy of Postgraduate Education of Roszdrav", Chair of endocrinology and diabetology with course of endocrine surgery based at FSI "Central Clinical hospital of civil aviation"
🇷🇺Moscow, Russian Federation
St. Petersburg State healthcare institution "City Outpatient Clinic #37"
🇷🇺Saint Petersburg, Russian Federation
FSHI "Clinical Hospital #122 n.a. L.G. Sokolov of FMBA of Russia", Internal medicine department
🇷🇺Saint Petersburg, Russian Federation
Municipal health care institution "City polyclinic №20
🇷🇺Saratov, Russian Federation
St. Petersburg State healthcare institution "City Hospital of Saint Martyr Elizaveta"
🇷🇺Saint Petersburg, Russian Federation
"Diabetes Center "LLC
🇷🇺Samara, Russian Federation
State budget educational institution of higher education "Smolensk State Medical Academy," of Ministry of Health and Social Development of the Russian Federation on the basis of sanatorium SSMA
🇷🇺Smolensk, Russian Federation
Municipal clinical health institution Health Service Novo-Yaroslavl Oil Refinery
🇷🇺Yaroslavl, Russian Federation
SHI of Yaroslavl region "Regional Clinical Hospital", Endocrinology department
🇷🇺Yaroslavl, Russian Federation
State Budget Educational Institution of higher professional education "1st Moscow State Medical University n.a. I.M. Sechenov of the Ministry of Healthcare of Russian Federation" based on Endocrinology department of Hospital № 67 n.a L A Vorohobova
🇷🇺Moscow, Russian Federation