Clinical trial NCT03088670: 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.
Official title: Evaluate 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: SatRx LLC
Sponsor class: INDUSTRY
First posted: 2017-03-23
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean change of HbA1c
timeFrame: at Weeks 12 and 36 from baseline
Secondary outcomes:
measure: HbA1c level of ≤7%
timeFrame: at Weeks 12 and 36 from baseline
measure: Hypoglycemic episodes
timeFrame: up to 36 week
measure: Fasting plasma glucose
timeFrame: at Weeks 12 and 36
measure: Change of Body Mass
timeFrame: at Weeks 12 and 36
measure: Adverse event
timeFrame: up to 40 week
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Non-state healthcare Organization "Road Clinical Hospital at the station Chelyabinsk Open Joint Stock Company" Russian Railways
city: Moscow
country: Russian Federation
facility: State Budget Healthcare Institution of Moscow "Endocrinology Dispensary"
city: Moscow
country: Russian Federation
facility: 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"
city: Moscow
country: Russian Federation
facility: 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"
city: Moscow
country: Russian Federation
facility: Federal State Institution "Clinical Hospital № 1" of the Office of the President of the Russian Federation
city: Moscow
country: Russian Federation
facility: State Budget Healthcare Institution of Moscow city "City Clinical Hospital # 71 by the Department of Healthcare in Moscow"
city: Moscow
country: Russian Federation
facility: 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
city: Moscow
country: Russian Federation
facility: 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"
city: Nizhny Novgorod
country: Russian Federation
facility: State budgetary institution "Nizhny Novgorod Regional Clinical Hospital n.a Semashko
city: Perm
country: Russian Federation
facility: State Health Care Institution "Perm Regional Hospital for War Veterans"
city: Perm
country: Russian Federation
facility: 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
city: Petrozavodsk
country: Russian Federation
facility: SHI "Republic Hospital n.a. V.A. Baranov"
city: Ryazan
country: Russian Federation
facility: State budgetary institution of Ryazan region "City Clinical Hospital № 11"
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State healthcare institution "City Outpatient Clinic #37"
city: Saint Petersburg
country: Russian Federation
facility: FSHI "Clinical Hospital #122 n.a. L.G. Sokolov of FMBA of Russia", Internal medicine department
city: Saint Petersburg
country: Russian Federation
facility: State Health Care Institution Leningrad Regional Hospital
city: Saint Petersburg
country: Russian Federation
facility: Autonomous Noncommercial Organization "Medical Centre "XXI сentury"
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State healthcare institution "City Hospital of Saint Martyr Elizaveta"
city: Saint Petersburg
country: Russian Federation
facility: 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
city: Samara
country: Russian Federation
facility: "Diabetes Center "LLC
city: Saratov
country: Russian Federation
facility: 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
city: Saratov
country: Russian Federation
facility: Municipal health care institution "City polyclinic №20
city: Smolensk
country: Russian Federation
facility: 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
city: Smolensk
country: Russian Federation
facility: 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
city: Yaroslavl
country: Russian Federation
facility: State autonomous healthcare institution of Yaroslavl Region "Сlinical hospital for emergency medical care n. a. N.V. Solovyov"
city: Yaroslavl
country: Russian Federation
facility: Municipal clinical health institution Health Service Novo-Yaroslavl Oil Refinery
city: Yaroslavl
country: Russian Federation
facility: SHI of Yaroslavl region "Regional Clinical Hospital", Endocrinology department
Study officials:
References: