Condition or disease | Intervention/treatment | Phase |
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Diabetes Mellitus, Type 1 Diabetes Mellitus | Drug: Lantus Solostar, 100 Units/mL Subcutaneous Solution Drug: Insulin RinGlar, 100 Units/mL Subcutaneous Solution | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 180 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of Insulin RinGlar® ("Geropharm", Russia) Compared to Lantus® SoloStar® ("Sanofi-Aventis Deutschland GmbH", Germany) in Type 1 Diabetes Mellitus Patients |
Actual Study Start Date : | July 4, 2018 |
Actual Primary Completion Date : | February 25, 2019 |
Actual Study Completion Date : | May 15, 2019 |
Arm | Intervention/treatment |
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Active Comparator: Lantus® SoloStar®
Lantus® SoloStar® once a day, individually glucose-level based administered in stable doses, started before enrollement
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Drug: Lantus Solostar, 100 Units/mL Subcutaneous Solution
4 weeks of glucose-level based dose titration, 22 weeks of treatment with stable doses
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Experimental: Insulin RinGlar®
Insulin RinGlar® once a day, individually glucose-level based administered in stable doses, started before enrollement
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Drug: Insulin RinGlar, 100 Units/mL Subcutaneous Solution
4 weeks of glucose-level based dose titration, 22 weeks of treatment with stable doses
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Hemoglobin value < 9,0 g/dl; Hematocrit value < 30 %; ALT and AST value > 2 folds as high as maximal normal value; Serum bilirubin value > 1.5 folds as high as maximal normal value
Russian Federation | |
Arkhangelsk Regional Clinical Hospital | |
Arkhangel'sk, Russian Federation, 163045 | |
Kazan Endocrinology Dispensary | |
Kazan, Russian Federation, 420073 | |
Krasnoyarsk State Medical University named after Professor V.F. Voino-Yasenetsky | |
Krasnoyarsk, Russian Federation, 660022 | |
Endocrinology Research Centre (Moscow) | |
Moscow, Russian Federation, 117036 | |
V.A. Baranov Republic Hospital | |
Petrozavodsk, Russian Federation, 185000 | |
Rostov State Medical University | |
Rostov-on-Don, Russian Federation, 344022 | |
Polyclinic Сomplex | |
Saint Petersburg, Russian Federation, 190013 | |
City Diagnostic Center № 1 | |
Saint Petersburg, Russian Federation, 194354 | |
City Hospital № 2 | |
Saint Petersburg, Russian Federation, 194354 | |
City Polyclinic № 117 | |
Saint Petersburg, Russian Federation, 194358 | |
EosMed | |
Saint Petersburg, Russian Federation, 195197 | |
Almazov National Medical Research Centre | |
Saint Petersburg, Russian Federation, 197341 | |
Pokrovskaya Municipal Hospital | |
Saint Petersburg, Russian Federation, 199106 | |
Clinical City Hospital № 9 | |
Saratov, Russian Federation, 410030 |
Principal Investigator: | Tatyana L Karonova, MD, DSc | Almazov National Medical Research Centre |
Tracking Information | |||||
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First Submitted Date ICMJE | July 5, 2019 | ||||
First Posted Date ICMJE | July 17, 2019 | ||||
Last Update Posted Date | July 17, 2019 | ||||
Actual Study Start Date ICMJE | July 4, 2018 | ||||
Actual Primary Completion Date | February 25, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Antibody Response [ Time Frame: 26 weeks ] Change from baseline in titer of antibodies to human insulin
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Efficacy and Safety of Insulin RinGlar® Compared to Lantus® SoloStar® in Type 1 Diabetes Mellitus Patients | ||||
Official Title ICMJE | An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of Insulin RinGlar® ("Geropharm", Russia) Compared to Lantus® SoloStar® ("Sanofi-Aventis Deutschland GmbH", Germany) in Type 1 Diabetes Mellitus Patients | ||||
Brief Summary | The study is designed to approve non-inferior efficacy and safety of Insulin RinGlar® compared to Lantus® SoloStar® in Type 1 Diabetes Mellitus Patients. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Karonova TL, Mosikian AA, Mayorov AY, Makarenko IE, Zyangirova ST, Afonkina OA, Belikova TM, Zalevskaya AG, Khokhlov AL, Drai RV. Safety and efficacy of GP40061 compared with originator insulin glargine (Lantus(®)): a randomized open-label clinical trial. J Comp Eff Res. 2020 Mar;9(4):263-273. doi: 10.2217/cer-2019-0136. Epub 2020 Feb 6. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
180 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | May 15, 2019 | ||||
Actual Primary Completion Date | February 25, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
Hemoglobin value < 9,0 g/dl; Hematocrit value < 30 %; ALT and AST value > 2 folds as high as maximal normal value; Serum bilirubin value > 1.5 folds as high as maximal normal value
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Russian Federation | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04022993 | ||||
Other Study ID Numbers ICMJE | GLARGIN-IM | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Geropharm | ||||
Study Sponsor ICMJE | Geropharm | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Geropharm | ||||
Verification Date | January 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |