Diabetes Mellitus, Type 2Phase 3NCT04012775
Efficacy and Safety of Insulin Rinsulin® NPH Compared to Humulin® NPH in Type 2 Diabetes Mellitus Patients
A Phase 3 study testing Insulin Humulin® NPH and Insulin Rinsulin® NPH in people with Diabetes Mellitus, Type 2, run by Geropharm at 14 sites in Russia.
Trial summary
The study is designed to approve non-inferior efficacy and safety of Rinsulin® NPH compared to Humulin® NPH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin Humulin® NPH and Insulin Rinsulin® NPH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 14 sitesRussia
- Study dates
- 20 Apr 2017to 24 Sep 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written consent
- Diabetes mellitus type 2
- Indications for Rinsulin NPH / Humalog NPH treatment
- Glycosylated hemoglobin (HbA1c) level of 6.5 to 12.0 % at screening (both values inclusive)
- Body mass index (BMI) of 18.0 to 35 kg/m2 at screening (both values inclusive).
- Female patients of childbearing potential who are willing to use two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), from the time of screening and for the duration of the trial, through trial completion.
Who cannot join
- Age less than 18 years old at screening
- Pregnant and breast-feeding women
- Need of administration of glucocorticoid therapy or any other therapy that may influence glucose level
- Administration of any immunosupressive drugs (Cyclosporinum, Methotrexatum)
- Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg), hepatitis C (HCVAb) or antibodies to Treponema pallidum (syphilis) at screening.
- History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the trial, OR history of significant allergic drug reactions.
Show all 13Show fewer
- History of hematological disorders that can affect the reliability of HbA1c estimation (hemoglobinopathies, hemolytic anemia, etc.).
- History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study
- Presence of severe diabetes complications
- Receipt of another investigational drug in the 3 months prior to screening
- Acute psychiatric disorder or exacerbation of chronic psychiatric disorder at screening
- History or presence of drug abuse
- Positive test for addictive substance in urine at screening
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Russia14 sites
Chelyabinsk Railway Clinical Hospital
Chelyabinsk, 454000
Moscow Endocrinological Dispensary
Moscow, 119034
Moscow Clinical Hospital № 71
Moscow, 121374
Nizhny Novgorod Regional Clinical Hospital
Nizhny Novgorod, 603126
V.A. Baranov Republic Hospital
Petrozavodsk, 185000
City Polyclinic № 6
Saint Petersburg, 192148
City Hospital № 2
Saint Petersburg, 194354
City Polyclinic № 17
Saint Petersburg, 195176
Medical Sanitary Unit № 157
Saint Petersburg, 196066
Institute of Medical Research
Saint Petersburg, 196084
Research Center Eco-Safety
Saint Petersburg, 196143
Saint Petersburg State Diagnostic Center № 85
Saint Petersburg, 198260
Diabetes Center
Samara, 443067
Clinical Hospital № 3
Yaroslavl, 150007
About this study
Official title: An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of Rinsulin® NPH ("Geropharm", Russia) With Humulin® NPH ("Lilly France", France) in Type 2 Diabetes Mellitus Patients
The study is designed to approve non-inferior efficacy and safety of Rinsulin® NPH compared to Humulin® NPH.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin Humulin® NPH, Insulin Rinsulin® NPH
- Keywords
- diabetes mellitus, insulin
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin Humulin® NPHBiological
4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses
Insulin Rinsulin® NPHBiological
4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses
| Study group | Role | What they receive |
|---|---|---|
| Insulin Humulin® NPH | Active comparator | Insulin Humulin® NPH twice daily, individually glucose-level based administered doses +/- 1,2 or 3 OADs in stable doses, started before enrollment Receives: Biological: Insulin Humulin® NPH |
| Insulin Rinsulin® NPH | Experimental | Insulin Rinsulin® NPH twice daily, individually glucose-level based administered doses +/- 1,2 or 3 OADs in stable doses, started before enrollment Receives: Biological: Insulin Rinsulin® NPH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody Response
Change from baseline in titer of antibodies to human insulin
Measured: 24 weeks
Secondary outcomes (10)
Hypoglycemic episodes (glucose level < 3.9 mmol/l) frequency
Measured: 28 weeks (4 + 24 weeks)
Change in BMI from baseline
Measured: 24 weeks
Occurrence of adverse events
Measured: 28 weeks (4 + 24 weeks)
Occurrence of Injection Site Reaction
Measured: 28 weeks (4 + 24 weeks)
Change in HbA1c from baseline
Measured: 24 weeks
Change in fasting plasma glucose level from baseline
Measured: 4 weeks
Change in fasting plasma glucose level from baseline
Measured: 16 weeks
Change in fasting plasma glucose level from baseline
Measured: 28 weeks
Change in basal insulin dose per body weight (U/kg) from baseline
Measured: 24 weeks
Change in total basal insulin dose (U) from baseline
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start20 Apr 2017
- Primary completion24 Sep 2018
- Study completion24 Sep 2018
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
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geropharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olga A Miroshnichenko, PhD, Principal investigator, Saint Petersburg State Diagnostic Center № 85
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012775
- Sponsor's protocol ID
- RINPH-IM
- Status last verified
- Jan 2019
- First submitted
- 5 Jul 2019
- Last updated
- 9 Jul 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 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of Rinsulin® NPH ("Geropharm", Russia) With Humulin® NPH ("Lilly France", France) in Type 2 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT04012775
- Acronym / sponsor ID
- RINPH-IM
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes mellitus, insulin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- GeropharmIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 24 Sep 2018 (actual)
- Study completion
- 24 Sep 2018 (actual)
- First posted
- 9 Jul 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.
The study is designed to approve non-inferior efficacy and safety of Rinsulin® NPH compared to Humulin® NPH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Humulin® NPH | Active comparator | Biological: Insulin Humulin® NPHInsulin Humulin® NPH twice daily, individually glucose-level based administered doses +/- 1,2 or 3 OADs in stable doses, started before enrollment |
| Insulin Rinsulin® NPH | Experimental | Biological: Insulin Rinsulin® NPHInsulin Rinsulin® NPH twice daily, individually glucose-level based administered doses +/- 1,2 or 3 OADs in stable doses, started before enrollment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed written consent
- Diabetes mellitus type 2
- Indications for Rinsulin NPH / Humalog NPH treatment
- Glycosylated hemoglobin (HbA1c) level of 6.5 to 12.0 % at screening (both values inclusive)
- Body mass index (BMI) of 18.0 to 35 kg/m2 at screening (both values inclusive).
Key exclusion criteria (13 listed)
- Age less than 18 years old at screening
- Pregnant and breast-feeding women
- Need of administration of glucocorticoid therapy or any other therapy that may influence glucose level
- Administration of any immunosupressive drugs (Cyclosporinum, Methotrexatum)
- Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg), hepatitis C (HCVAb) or antibodies to Treponema pallidum (syphilis) at screening.
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 |
|---|---|---|
| Insulin Humulin® NPH4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses | Biological | Insulin Humulin® NPH |
| Insulin Rinsulin® NPH4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses | Biological | Insulin Rinsulin® NPH |
Primary outcome
Antibody Response
Time frame: 24 weeks
Change from baseline in titer of antibodies to human insulin
10 secondary outcomes
Hypoglycemic episodes (glucose level < 3.9 mmol/l) frequency
Time frame: 28 weeks (4 + 24 weeks)
Change in BMI from baseline
Time frame: 24 weeks
Occurrence of adverse events
Time frame: 28 weeks (4 + 24 weeks)
Occurrence of Injection Site Reaction
Time frame: 28 weeks (4 + 24 weeks)
Change in HbA1c from baseline
Time frame: 24 weeks
Change in fasting plasma glucose level from baseline
Time frame: 4 weeks
Change in fasting plasma glucose level from baseline
Time frame: 16 weeks
Change in fasting plasma glucose level from baseline
Time frame: 28 weeks
Change in basal insulin dose per body weight (U/kg) from baseline
Time frame: 24 weeks
Change in total basal insulin dose (U) from baseline
Time frame: 24 weeks
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 9 Jul 2019.
- 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.
Olga A Miroshnichenko, PhD principal investigator
Saint Petersburg State Diagnostic Center № 85
14 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 Insulin Humulin® NPH and Insulin Rinsulin® NPH in people with Diabetes Mellitus, Type 2, run by Geropharm at 14 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 6 inclusion and 13 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 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
Antibody Response (time frame: 24 weeks). 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 9 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.