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.

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.

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).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Gosogliptin; Drug: Metformin; Drug: Vildagliptin

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.

• Study Type: Interventional
• Enrollment (Actual): 299
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Chelyabinsk, Russian Federation, 454048
    • Non-state healthcare Organization "Road Clinical Hospital at the station Chelyabinsk Open Joint Stock Company" Russian Railways
  • Moscow, Russian Federation, 119034
    • State Budget Healthcare Institution of Moscow "Endocrinology Dispensary"
  • Moscow, Russian Federation, 119048
    • 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, 119435
    • 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, 121352
    • Federal State Institution "Clinical Hospital № 1" of the Office of the President of the Russian Federation
  • Moscow, Russian Federation, 121374
    • State Budget Healthcare Institution of Moscow city "City Clinical Hospital # 71 by the Department of Healthcare in Moscow"
  • Moscow, Russian Federation, 123423
    • 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, 125367
    • 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"
  • Nizhny Novgorod, Russian Federation, 603126
    • State budgetary institution "Nizhny Novgorod Regional Clinical Hospital n.a Semashko
  • Perm, Russian Federation, 614097
    • State Health Care Institution "Perm Regional Hospital for War Veterans"
  • Perm, Russian Federation, 614990
    • 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
  • Petrozavodsk, Russian Federation, 185019
    • SHI "Republic Hospital n.a. V.A. Baranov"
  • Ryazan, Russian Federation, 390037
    • State budgetary institution of Ryazan region "City Clinical Hospital № 11"
  • Saint Petersburg, Russian Federation, 191119
    • St. Petersburg State healthcare institution "City Outpatient Clinic #37"
  • Saint Petersburg, Russian Federation, 194291
    • FSHI "Clinical Hospital #122 n.a. L.G. Sokolov of FMBA of Russia", Internal medicine department
  • Saint Petersburg, Russian Federation, 194291
    • State Health Care Institution Leningrad Regional Hospital
  • Saint Petersburg, Russian Federation, 194354
    • Autonomous Noncommercial Organization "Medical Centre "XXI сentury"
  • Saint Petersburg, Russian Federation, 195257
    • St. Petersburg State healthcare institution "City Hospital of Saint Martyr Elizaveta"
  • Saint Petersburg, Russian Federation, 198013
    • 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
  • Samara, Russian Federation, 443041
    • "Diabetes Center "LLC
  • Saratov, Russian Federation, , 410054
    • 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, 410018
    • Municipal health care institution "City polyclinic №20
  • Smolensk, Russian Federation, 214019
    • 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, 214019
    • 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
  • Yaroslavl, Russian Federation, 150003
    • State autonomous healthcare institution of Yaroslavl Region "Сlinical hospital for emergency medical care n. a. N.V. Solovyov"
  • Yaroslavl, Russian Federation, 150023
    • Municipal clinical health institution Health Service Novo-Yaroslavl Oil Refinery
  • Yaroslavl, Russian Federation, 150062
    • SHI of Yaroslavl region "Regional Clinical Hospital", Endocrinology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gosogliptin treatment group; 12 weeks of monotherapy and 24 weeks of combination with Metformin	Drug: Gosogliptin; 20 mg per day, dose titration to 30 mg per day at Week 4 as required Administration: orally; 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
Active Comparator: Vildagliptin treatment group; 12 weeks of monotherapy and 24 weeks of combination with Metformin	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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change of HbA1c	Gosogliptin treatment group vs. Vildagliptin treatment group	at Weeks 12 and 36 from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c level of ≤7%	Percent of patients who reach the target HbA1c	at Weeks 12 and 36 from baseline
Hypoglycemic episodes	Incidence of hypoglycemic episodes during the monotherapy and in combination with Metformin	up to 36 week
Fasting plasma glucose	Change of fasting plasma glucose from baseline	at Weeks 12 and 36
Change of Body Mass	Change of Body Mass from baseline	at Weeks 12 and 36
Adverse event	AE rate	up to 40 week

Collaborators and Investigators

• Sponsor: SatRx LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2013
• Primary Completion (Actual): March 30, 2014
• Study Completion (Actual): October 3, 2014

Study Registration Dates

• First Submitted: March 18, 2017
• First Submitted That Met QC Criteria: March 18, 2017
• First Posted (Actual): March 23, 2017

Study Record Updates

• Last Update Posted (Actual): March 23, 2017
• Last Update Submitted That Met QC Criteria: March 18, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Metformin; Vildagliptin
• Other Study ID Numbers: SRX-1374-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No