Diabetes Mellitus, Type 2Phase 3NCT03088670
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.
A Phase 3 study testing Gosogliptin, Vildagliptin and Metformin in people with Diabetes Mellitus, Type 2, run by SatRx LLC at 27 sites in Russia.
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). Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Gosogliptin, Vildagliptin and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 27 sitesRussia
- Study dates
- 23 Apr 2013to 3 Oct 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
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- FPG < 15 mmol/L
- Signed informed consent
- Patient's ability to follow all protocol requirements
Who cannot join
- 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);
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- 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
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Russia27 sites
Non-state healthcare Organization "Road Clinical Hospital at the station Chelyabinsk Open Joint Stock Company" Russian Railways
Chelyabinsk, 454048
State Budget Healthcare Institution of Moscow "Endocrinology Dispensary"
Moscow, 119034
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, 119048
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, 119435
Federal State Institution "Clinical Hospital № 1" of the Office of the President of the Russian Federation
Moscow, 121352
State Budget Healthcare Institution of Moscow city "City Clinical Hospital # 71 by the Department of Healthcare in Moscow"
Moscow, 121374
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, 123423
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, 125367
State budgetary institution "Nizhny Novgorod Regional Clinical Hospital n.a Semashko
Nizhny Novgorod, 603126
State Health Care Institution "Perm Regional Hospital for War Veterans"
Perm, 614097
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, 614990
SHI "Republic Hospital n.a. V.A. Baranov"
Petrozavodsk, 185019
State budgetary institution of Ryazan region "City Clinical Hospital № 11"
Ryazan, 390037
St. Petersburg State healthcare institution "City Outpatient Clinic #37"
Saint Petersburg, 191119
FSHI "Clinical Hospital #122 n.a. L.G. Sokolov of FMBA of Russia", Internal medicine department
Saint Petersburg, 194291
State Health Care Institution Leningrad Regional Hospital
Saint Petersburg, 194291
Autonomous Noncommercial Organization "Medical Centre "XXI сentury"
Saint Petersburg, 194354
St. Petersburg State healthcare institution "City Hospital of Saint Martyr Elizaveta"
Saint Petersburg, 195257
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, 198013
"Diabetes Center "LLC
Samara, 443041
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, , 410054
Municipal health care institution "City polyclinic №20
Saratov, 410018
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, 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
Smolensk, 214019
State autonomous healthcare institution of Yaroslavl Region "Сlinical hospital for emergency medical care n. a. N.V. Solovyov"
Yaroslavl, 150003
Municipal clinical health institution Health Service Novo-Yaroslavl Oil Refinery
Yaroslavl, 150023
SHI of Yaroslavl region "Regional Clinical Hospital", Endocrinology department
Yaroslavl, 150062
About this study
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.
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).
Read the 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
- Being tested
- Gosogliptin, Vildagliptin, Metformin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GosogliptinDrug
20 mg per day, dose titration to 30 mg per day at Week 4 as required Administration: orally
VildagliptinDrug
50 mg per day, dose titration to 100 mg per day at Week 4 as required (50 mg twice a day) Administration: orally
MetforminDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Gosogliptin treatment group | Experimental | 12 weeks of monotherapy and 24 weeks of combination with Metformin Receives: Drug: Gosogliptin; Drug: Metformin |
| Vildagliptin treatment group | Active comparator | 12 weeks of monotherapy and 24 weeks of combination with Metformin Receives: Drug: Vildagliptin; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change of HbA1c
Gosogliptin treatment group vs. Vildagliptin treatment group
Measured: at Weeks 12 and 36 from baseline
Secondary outcomes (5)
HbA1c level of ≤7%
Percent of patients who reach the target HbA1c
Measured: at Weeks 12 and 36 from baseline
Hypoglycemic episodes
Incidence of hypoglycemic episodes during the monotherapy and in combination with Metformin
Measured: up to 36 week
Fasting plasma glucose
Change of fasting plasma glucose from baseline
Measured: at Weeks 12 and 36
Change of Body Mass
Change of Body Mass from baseline
Measured: at Weeks 12 and 36
Adverse event
AE rate
Measured: up to 40 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start23 Apr 2013
- Primary completion30 Mar 2014
- Study completion3 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- SatRx LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088670
- Sponsor's protocol ID
- SRX-1374-02
- Status last verified
- Mar 2017
- First submitted
- 18 Mar 2017
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03088670
- Acronym / sponsor ID
- SRX-1374-02
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- SatRx LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2013 (actual)
- Primary completion
- 30 Mar 2014 (actual)
- Study completion
- 3 Oct 2014 (actual)
- First posted
- 23 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gosogliptin treatment group | Experimental | Drug: Gosogliptin, Drug: Metformin12 weeks of monotherapy and 24 weeks of combination with Metformin |
| Vildagliptin treatment group | Active comparator | Drug: Vildagliptin, Drug: Metformin12 weeks of monotherapy and 24 weeks of combination with Metformin |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gosogliptin20 mg per day, dose titration to 30 mg per day at Week 4 as required Administration: orally | Drug | Gosogliptin treatment group |
| Vildagliptin50 mg per day, dose titration to 100 mg per day at Week 4 as required (50 mg twice a day) Administration: orally | Drug | Vildagliptin treatment group |
| Metformin1000 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 | Gosogliptin treatment group, Vildagliptin treatment group |
Primary outcome
Mean change of HbA1c
Time frame: at Weeks 12 and 36 from baseline
Gosogliptin treatment group vs. Vildagliptin treatment group
5 secondary outcomes
HbA1c level of ≤7%
Time frame: at Weeks 12 and 36 from baseline
Hypoglycemic episodes
Time frame: up to 36 week
Fasting plasma glucose
Time frame: at Weeks 12 and 36
Change of Body Mass
Time frame: at Weeks 12 and 36
Adverse event
Time frame: up to 40 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gosogliptin, Vildagliptin and Metformin in people with Diabetes Mellitus, Type 2, run by SatRx LLC at 27 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change of HbA1c (time frame: at Weeks 12 and 36 from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.