Clamp StudyNCT04101383
A Study to Compare Pharmacokinetics and Pharmacodynamics of RinGlar® to Lantus® in Type 1 Diabetes Mellitus Patients
A study testing RinGlar® and Lantus® in people with Clamp Study, run by Geropharm at 2 sites in Russia.
Trial summary
Pharmacokinetics and pharmacodynamics study of 2 formulation of insulin glargine (RinGlar® GEROPHARM vers. Lantus® Sanofi-Aventis) Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Clamp Study
- What is being tested?
- RinGlar® and Lantus®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesRussia
- Study dates
- 16 Oct 2017to 16 Feb 2018
- Phase
- Interventional
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Caucasian males having confirmed diabetes mellitus type 1 (WHO criteria) for at least 12 months prior to screening.
- Age of 18-65 (both incl.).
- HbA1С ≤ 8,0 %.
- Insulin therapy in stable doses at least 3 months. Total dose of insulin ≤ 1,2 IU/kg per day.
- At least 6 months of Lantus use.
Show all 10Show fewer
- C-peptide ≤ 0,3 nM/L (or 0,5 ng/mL).
- Body mass index equal to 18.5-32.0 kg/m2.
- Subject must use, with their partner, methods of highly effective contraception throughout the study.
- Subject is able and willing to comply with the requirements of the study protocol.
Who cannot join
- Acute inflammatory diseases within 3 weeks before the screening period.
- History or presence of uncontrolled diabetes mellitus for 6 months prior to screening.
- Clinically significant diabetes mellitus complications (proliferative retinopathy, severe diabetic neuropathy, diabetic nephropathy (CKD-EPI < 60 mL/min/1,73 m2), diabetic foot).
- Clinically significant deviations in basic vital signs (blood pressure, heart rate, respiration rate, body temperature), ECG and lab tests.
- Deep vein thrombosis of lower extremities in a history of life or in a family history.
- Taking medications (excl. insulin and ACE-inhibitors), phytopreparations, biologically active supplements less than 14 days before screening.
Show all 22Show fewer
- Donor blood donation or another blood loss, less than 3 months before the study.
- Recovery after surgery process.
- Mental, physical and other reasons that do not allow to adequately assess their behavior and properly fulfill the conditions of the research protocol, including psychiatric disorders.
- History of significant drugs abuse conditions for 3 years prior to screening.
- Positive testing for drugs.
- Receiving more than 10 units. alcohol per week (1 unit of alcohol is equivalent to 0.5 liters of beer, 200 ml of wine or 50 ml of strong alcohol) or anamnestic information about alcoholism.
- Positive testing for alcohol.
- Nicotine dependence (use of tobacco less than 6 months before the start of screening).
- Positive test results for hepatitis C or hepatitis B, HIV, syphilis.
- Presence of suspicions of an inflammatory disease of the urinary system as a result of urinalysis.
- Weighed allergic anamnesis.
- Presence of oncology disease in the anamnesis 5 years prior the start of screening.
- Organ transplantation in anamnesis (excl. cornea transplantation at least 3 month prior the IP administration).
- Participation in a clinical trial of any medications less than 3 months before the IP administration.
- Any other conditions that make it difficult, according to the informed opinion of the investigating physician, that volunteer participation in studies.
- History of hypersensitivity to insulin, heparin and excipients of the drugs using in study.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Endocrinology Research Centre
Moscow, 117036
Almazov National Medical Research Centre
Saint Petersburg, 197341
About this study
Official title: A Randomized Double Blinded Two-way Crossover Single-dose Pharmacokinetics and Pharmacodynamics Study of RinGlar® (LLC "GEROPHARM", Russia) Versus Lantus® (Sanofi-Aventis) in Type 1 Diabetes Mellitus Patients Using the Euglycemic Clamp Technique
Pharmacokinetics and pharmacodynamics study of 2 formulation of insulin glargine (RinGlar® GEROPHARM vers. Lantus® Sanofi-Aventis)
Read the detailed description
A randomized double blinded two-way crossover single-dose pharmacokinetics and pharmacodynamics study of RinGlar® (LLC "GEROPHARM", Russia) versus Lantus® (Sanofi-Aventis) in Type 1 Diabetes Mellitus Patients using the euglycemic clamp technique
- Conditions
- Clamp Study
- Being tested
- RinGlar®, Lantus®
- Keywords
- Pharmacokinetics, Pharmacodynamics, Insulin glargine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RinGlar®Drug
Also called insulin glargine
Single subcutaneous administration of RinGlar® in dose 0.6 Units/kg
Lantus®Drug
Also called insulin glargine
Single subcutaneous administration of Lantus® in dose 0.6 Units/kg
| Study group | Role | What they receive |
|---|---|---|
| RinGlar® | Experimental | Single subcutaneous administration of RinGlar® in dose 0.6 Units/kg Receives: Drug: RinGlar® |
| Lantus® | Active comparator | Single subcutaneous administration of Lantus® in dose 0.6 Units/kg Receives: Drug: Lantus® |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC GIR(0-t)
Pharmacodynamic of insulin glargine by Assessment of GIR Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))
Measured: 0 hours (pre-dose), as well as at, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 420, 480, 540, 600, 660, 720, 780, 840, 900, 960, 1020, 1080, 1140, 1200, 1260, 1320, 1380, 1440 minutes post-dose
AUC(0-t)
Pharmacokinetics of insulin glargine by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))
Measured: -60, -30 and 0 hours (pre-dose), as well as at, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 420, 480, 540, 600, 660, 720, 780, 840, 900, 960, 1020, 1080, 1140, 1200, 1260, 1320, 1380, 1440 minutes post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start16 Oct 2017
- Primary completion16 Feb 2018
- Study completion16 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clamp StudyStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- two-way crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geropharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101383
- Sponsor's protocol ID
- GLARGIN-CL
- Status last verified
- Sep 2019
- First submitted
- 23 Sep 2019
- Last updated
- 24 Sep 2019
- 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 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blinded Two-way Crossover Single-dose Pharmacokinetics and Pharmacodynamics Study of RinGlar® (LLC "GEROPHARM", Russia) Versus Lantus® (Sanofi-Aventis) in Type 1 Diabetes Mellitus Patients Using the Euglycemic Clamp Technique
- ClinicalTrials.gov ID
- NCT04101383
- Acronym / sponsor ID
- GLARGIN-CL
- Conditions
- Clamp Study
- Keywords
- Pharmacokinetics, Pharmacodynamics, Insulin glargine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- GeropharmIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 16 Feb 2018 (actual)
- Study completion
- 16 Feb 2018 (actual)
- First posted
- 24 Sep 2019 (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.
Pharmacokinetics and pharmacodynamics study of 2 formulation of insulin glargine (RinGlar® GEROPHARM vers. Lantus® Sanofi-Aventis)
Detailed description
A randomized double blinded two-way crossover single-dose pharmacokinetics and pharmacodynamics study of RinGlar® (LLC "GEROPHARM", Russia) versus Lantus® (Sanofi-Aventis) in Type 1 Diabetes Mellitus Patients using the euglycemic clamp technique
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- two-way crossover
| Arm | Type | Receives |
|---|---|---|
| RinGlar® | Experimental | Drug: RinGlar®Single subcutaneous administration of RinGlar® in dose 0.6 Units/kg |
| Lantus® | Active comparator | Drug: Lantus®Single subcutaneous administration of Lantus® in dose 0.6 Units/kg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent.
- Caucasian males having confirmed diabetes mellitus type 1 (WHO criteria) for at least 12 months prior to screening.
- Age of 18-65 (both incl.).
- HbA1С ≤ 8,0 %.
- Insulin therapy in stable doses at least 3 months. Total dose of insulin ≤ 1,2 IU/kg per day.
Key exclusion criteria (22 listed)
- Acute inflammatory diseases within 3 weeks before the screening period.
- History or presence of uncontrolled diabetes mellitus for 6 months prior to screening.
- Clinically significant diabetes mellitus complications (proliferative retinopathy, severe diabetic neuropathy, diabetic nephropathy (CKD-EPI < 60 mL/min/1,73 m2), diabetic foot).
- Clinically significant deviations in basic vital signs (blood pressure, heart rate, respiration rate, body temperature), ECG and lab tests.
- Deep vein thrombosis of lower extremities in a history of life or in a family history.
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 |
|---|---|---|
| RinGlar®Also: insulin glargineSingle subcutaneous administration of RinGlar® in dose 0.6 Units/kg | Drug | RinGlar® |
| Lantus®Also: insulin glargineSingle subcutaneous administration of Lantus® in dose 0.6 Units/kg | Drug | Lantus® |
Primary outcome
AUC GIR(0-t)
Time frame: 0 hours (pre-dose), as well as at, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 420, 480, 540, 600, 660, 720, 780, 840, 900, 960, 1020, 1080, 1140, 1200, 1260, 1320, 1380, 1440 minutes post-dose
Pharmacodynamic of insulin glargine by Assessment of GIR Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))
AUC(0-t)
Time frame: -60, -30 and 0 hours (pre-dose), as well as at, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 420, 480, 540, 600, 660, 720, 780, 840, 900, 960, 1020, 1080, 1140, 1200, 1260, 1320, 1380, 1440 minutes post-dose
Pharmacokinetics of insulin glargine by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))
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 24 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Clamp Study
Not yet recruitingObservational study
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
Obesity Type 2 Diabetes Mellitus, Obese Adults
Active, not recruiting
Prone Positioning During Delayed Cord Clamping
Delayed Cord Clamping
Not yet recruiting
Noninvasive CA Monitoring Validation and Autonomic Modulation in Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Delayed Cerebral Ischemia
Not yet recruiting
Patient Reported Outcomes and Different Renal Artery Clamping Techniques During Robot Assisted Kidney Resection
Renal Cell Carcinoma (Kidney Cancer)
RecruitingPhase 2
Open-label Phase 2 Study of Avutometinib (RAF/MEK Clamp) in Combination With Defactinib (FAK Inhibitor) and Cetuximab in Patients With Unresectable, Anti-EGFR-Refractory Advanced Colorectal Cancer
Advanced Colorectal Cancer
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RinGlar® and Lantus® in people with Clamp Study, run by Geropharm at 2 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 10 inclusion and 22 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 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
AUC GIR(0-t) (time frame: 0 hours (pre-dose), as well as at, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 420, 480, 540, 600, 660, 720, 780, 840, 900, 960, 1020, 1080, 1140, 1200, 1260, 1320, 1380, 1440 minutes post-dose). The study lists 2 primary outcomes in all. 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 24 Sep 2019.