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.
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| ClinicalTrials.gov Identifier: NCT03088670 |
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Recruitment Status :
Completed
First Posted : March 23, 2017
Last Update Posted : March 23, 2017
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Sponsor:
SatRx LLC
Information provided by (Responsible Party):
SatRx LLC
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus, Type 2 | Drug: Gosogliptin Drug: Vildagliptin Drug: Metformin | Phase 3 |
- 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 (Clinical Trial) |
| Actual Enrollment : | 299 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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. |
| Actual Study Start Date : | April 23, 2013 |
| Actual Primary Completion Date : | March 30, 2014 |
| Actual Study Completion Date : | October 3, 2014 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Gosogliptin treatment group
12 weeks of monotherapy and 24 weeks of combination with Metformin
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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 |
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Active Comparator: Vildagliptin treatment group
12 weeks of monotherapy and 24 weeks of combination with Metformin
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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 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 |
Primary Outcome Measures :
- Mean change of HbA1c [ Time Frame: at Weeks 12 and 36 from baseline ]Gosogliptin treatment group vs. Vildagliptin treatment group
Secondary Outcome Measures :
- HbA1c level of ≤7% [ Time Frame: at Weeks 12 and 36 from baseline ]Percent of patients who reach the target HbA1c
- Hypoglycemic episodes [ Time Frame: up to 36 week ]Incidence of hypoglycemic episodes during the monotherapy and in combination with Metformin
- Fasting plasma glucose [ Time Frame: at Weeks 12 and 36 ]Change of fasting plasma glucose from baseline
- Change of Body Mass [ Time Frame: at Weeks 12 and 36 ]Change of Body Mass from baseline
- Adverse event [ Time Frame: up to 40 week ]AE rate
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| Ages Eligible for Study: | 18 Years to 78 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088670
Locations
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Sponsors and Collaborators
SatRx LLC
| Responsible Party: | SatRx LLC |
| ClinicalTrials.gov Identifier: | NCT03088670 |
| Other Study ID Numbers: |
SRX-1374-02 |
| First Posted: | March 23, 2017 Key Record Dates |
| Last Update Posted: | March 23, 2017 |
| Last Verified: | March 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Metformin Vildagliptin |
Hypoglycemic Agents Physiological Effects of Drugs Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |