Diabetes Mellitus, Type 2SEASNCT01588639
To Evaluate Clinical Outcome and Injection Compliance of Scilin
An observational study of Diabetes Mellitus, Type 2, run by Bayer at 1 site in China.
Trial summary
This is a prospective, multi-center, open-label, non-interventional, 12-week study in people with type 2 diabetes mellitus who are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin (Scilin N, BAY81-9924), Insulin (Scilin R _BAY81-9924 and Insulin(Scilin M30_BAY81-9924)
- How many people
- 2,683 participants
- Where
- 1 siteChina
- Study dates
- Aug 2012to Jan 2014
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Based on physicians' clinical judgement, subjects who are treated with SciLin N, SciLin R and SciLin M30 ( alone or in combination) will be eligible to be included in this clinical study.
Who cannot join
- Subjects with one of the conditions listed below will be excluded:
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 months Subjects who have to be treated with other insulins simultaneously Subjects who are participating in other diabetes clinical studies at the same time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Multi-centre, Non-randomized, Open-label, Non-interventional Study to Evaluate the Safety, Efficacy and Injection Compliance of Scilin N, Scilin R or Scilin M30 in Chinese Type 2 Diabetes Mellitus (T2DM)
This is a prospective, multi-center, open-label, non-interventional, 12-week study in people with type 2 diabetes mellitus who are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice. The term study insulins will be used in this protocol for these drugs and combinations.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin (Scilin N, BAY81-9924), Insulin (Scilin R _BAY81-9924, Insulin(Scilin M30_BAY81-9924)
- Keywords
- Recombinant human insulin, T2DM, Safety, Efficacy
- 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.
Insulin (Scilin N, BAY81-9924)Drug
Subjects are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice.
Insulin (Scilin R _BAY81-9924Drug
Subjects are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice
Insulin(Scilin M30_BAY81-9924)Drug
Subjects are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Insulin (Scilin N, BAY81-9924); Drug: Insulin (Scilin R _BAY81-9924; Drug: Insulin(Scilin M30_BAY81-9924) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence rate of serious adverse drug reactions including severe hypoglycaemic events
Measured: up to 12 week
Secondary outcomes (6)
Occurrence rate of hypoglycemic events
Measured: up to 12 weeks
Change in HbA1c
Measured: Baseline and week 12
Change in FPG (Fasting Plasma Glucose)
Measured: Baseline and week 12
Change in PPG (Postprandial Glucose)
Measured: Baseline and week 12
The ratio of compliance injection (following physician's advice)
Measured: up to 12 weeks
Number and ratio of missed injections
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2013
- Study completionJan 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.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,683 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588639
- Sponsor's protocol ID
- 16372
- Other IDs
- SL1210CN
- Acronym
- SEAS
- Status last verified
- Jan 2015
- First submitted
- 27 Apr 2012
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-centre, Non-randomized, Open-label, Non-interventional Study to Evaluate the Safety, Efficacy and Injection Compliance of Scilin N, Scilin R or Scilin M30 in Chinese Type 2 Diabetes Mellitus (T2DM)
- ClinicalTrials.gov ID
- NCT01588639
- Acronym / sponsor ID
- SEAS / 16372
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Recombinant human insulin, T2DM, Safety, Efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,683 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 1 May 2012 (estimated)
- 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.
This is a prospective, multi-center, open-label, non-interventional, 12-week study in people with type 2 diabetes mellitus who are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice. The term study insulins will be used in this protocol for these drugs and combinations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Insulin (Scilin N, BAY81-9924), Drug: Insulin (Scilin R _BAY81-9924, Drug: Insulin(Scilin M30_BAY81-9924) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (1 listed)
- Based on physicians' clinical judgement, subjects who are treated with SciLin N, SciLin R and SciLin M30 ( alone or in combination) will be eligible to be included in this clinical study.
Key exclusion criteria (2 listed)
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 months Subjects who have to be treated with other insulins simultaneously Subjects who are participating in other diabetes clinical studies at the same time
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 (Scilin N, BAY81-9924)Subjects are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice. | Drug | Group 1 |
| Insulin (Scilin R _BAY81-9924Subjects are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice | Drug | Group 1 |
| Insulin(Scilin M30_BAY81-9924)Subjects are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice | Drug | Group 1 |
Primary outcome
Occurrence rate of serious adverse drug reactions including severe hypoglycaemic events
Time frame: up to 12 week
6 secondary outcomes
Occurrence rate of hypoglycemic events
Time frame: up to 12 weeks
Change in HbA1c
Time frame: Baseline and week 12
Change in FPG (Fasting Plasma Glucose)
Time frame: Baseline and week 12
Change in PPG (Postprandial Glucose)
Time frame: Baseline and week 12
The ratio of compliance injection (following physician's advice)
Time frame: up to 12 weeks
Number and ratio of missed injections
Time frame: up to 12 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 13 Jan 2015.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Bayer at 1 site in China.
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 1 inclusion and 2 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 13 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Occurrence rate of serious adverse drug reactions including severe hypoglycaemic events (time frame: up to 12 week). 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 13 Jan 2015.