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.

NCT ID: NCT03088670

Last Updated: 2017-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 299 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-23
• Study Completion Date: 2014-10-03

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gosogliptin treatment group

12 weeks of monotherapy and 24 weeks of combination with Metformin

Group Type: EXPERIMENTAL

Gosogliptin

Intervention Type: DRUG

20 mg per day, dose titration to 30 mg per day at Week 4 as required Administration: orally

Metformin

Intervention Type: DRUG

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

Vildagliptin treatment group

12 weeks of monotherapy and 24 weeks of combination with Metformin

Group Type: ACTIVE_COMPARATOR

Vildagliptin

Intervention Type: DRUG

50 mg per day, dose titration to 100 mg per day at Week 4 as required (50 mg twice a day) Administration: orally

Metformin

Intervention Type: DRUG

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

Interventions

Gosogliptin

20 mg per day, dose titration to 30 mg per day at Week 4 as required Administration: orally

Intervention Type: DRUG

Vildagliptin

50 mg per day, dose titration to 100 mg per day at Week 4 as required (50 mg twice a day) Administration: orally

Intervention Type: DRUG

Metformin

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SatRx LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Non-state healthcare Organization "Road Clinical Hospital at the station Chelyabinsk Open Joint Stock Company" Russian Railways

Chelyabinsk, , Russia

State Budget Healthcare Institution of Moscow "Endocrinology Dispensary"

Moscow, , Russia

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, , Russia

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, , Russia

Federal State Institution "Clinical Hospital № 1" of the Office of the President of the Russian Federation

Moscow, , Russia

State Budget Healthcare Institution of Moscow city "City Clinical Hospital # 71 by the Department of Healthcare in Moscow"

Moscow, , Russia

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, , Russia

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, , Russia

State budgetary institution "Nizhny Novgorod Regional Clinical Hospital n.a Semashko

Nizhny Novgorod, , Russia

State Health Care Institution "Perm Regional Hospital for War Veterans"

Perm, , Russia

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, , Russia

SHI "Republic Hospital n.a. V.A. Baranov"

Petrozavodsk, , Russia

State budgetary institution of Ryazan region "City Clinical Hospital № 11"

Ryazan, , Russia

St. Petersburg State healthcare institution "City Outpatient Clinic #37"

Saint Petersburg, , Russia

FSHI "Clinical Hospital #122 n.a. L.G. Sokolov of FMBA of Russia", Internal medicine department

Saint Petersburg, , Russia

State Health Care Institution Leningrad Regional Hospital

Saint Petersburg, , Russia

Autonomous Noncommercial Organization "Medical Centre "XXI сentury"

Saint Petersburg, , Russia

St. Petersburg State healthcare institution "City Hospital of Saint Martyr Elizaveta"

Saint Petersburg, , Russia

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, , Russia

"Diabetes Center "LLC

Samara, , Russia

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, , Russia

Municipal health care institution "City polyclinic №20

Saratov, , Russia

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, , Russia

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, , Russia

State autonomous healthcare institution of Yaroslavl Region "Сlinical hospital for emergency medical care n. a. N.V. Solovyov"

Yaroslavl, , Russia

Municipal clinical health institution Health Service Novo-Yaroslavl Oil Refinery

Yaroslavl, , Russia

SHI of Yaroslavl region "Regional Clinical Hospital", Endocrinology department

Yaroslavl, , Russia

Countries

Russia

Other Identifiers

SRX-1374-02

Identifier Type: -

Identifier Source: org_study_id