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.

Diabetes Mellitus, Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03088670
• Other study ID #: SRX-1374-02
• Status: Completed
• Phase: Phase 3
• First received: March 18, 2017
• Last updated: March 18, 2017
• Start date: April 23, 2013
• Est. completion date: October 3, 2014

Study information

• Verified date: March 2017
• Source: SatRx LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: October 3, 2014
• Est. primary completion date: March 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 78 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Gosogliptin
20 mg per day, dose titration to 30 mg per day at Week 4 as required Administration: orally
• Vildagliptin
50 mg per day, dose titration to 100 mg per day at Week 4 as required (50 mg twice a day) Administration: orally
• 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

Locations

Country	Name	City	State
Russian Federation	Non-state healthcare Organization "Road Clinical Hospital at the station Chelyabinsk Open Joint Stock Company" Russian Railways	Chelyabinsk
Russian Federation	Federal State Institution "Clinical Hospital ? 1" of the Office of the President of the Russian Federation	Moscow
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	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 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	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	State Budget Healthcare Institution of Moscow "Endocrinology Dispensary"	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 budgetary institution "Nizhny Novgorod Regional Clinical Hospital n.a Semashko	Nizhny Novgorod
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 "Perm Regional Hospital for War Veterans"	Perm
Russian Federation	SHI "Republic Hospital n.a. V.A. Baranov"	Petrozavodsk
Russian Federation	State budgetary institution of Ryazan region "City Clinical Hospital ? 11"	Ryazan
Russian Federation	Autonomous Noncommercial Organization "Medical Centre "XXI ?entury"	Saint Petersburg
Russian Federation	FSHI "Clinical Hospital #122 n.a. L.G. Sokolov of FMBA of Russia", Internal medicine department	Saint Petersburg
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	St. Petersburg State healthcare institution "City Hospital of Saint Martyr Elizaveta"	Saint Petersburg
Russian Federation	St. Petersburg State healthcare institution "City Outpatient Clinic #37"	Saint Petersburg
Russian Federation	State Health Care Institution Leningrad Regional Hospital	Saint Petersburg
Russian Federation	"Diabetes Center "LLC	Samara
Russian Federation	Municipal health care institution "City polyclinic ?20	Saratov
Russian Federation	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	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 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 autonomous healthcare institution of Yaroslavl Region "?linical hospital for emergency medical care n. a. N.V. Solovyov"	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
SatRx LLC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change of HbA1c	Gosogliptin treatment group vs. Vildagliptin treatment group	at Weeks 12 and 36 from baseline
Secondary	HbA1c level of =7%	Percent of patients who reach the target HbA1c	at Weeks 12 and 36 from baseline
Secondary	Hypoglycemic episodes	Incidence of hypoglycemic episodes during the monotherapy and in combination with Metformin	up to 36 week
Secondary	Fasting plasma glucose	Change of fasting plasma glucose from baseline	at Weeks 12 and 36
Secondary	Change of Body Mass	Change of Body Mass from baseline	at Weeks 12 and 36
Secondary	Adverse event	AE rate	up to 40 week