DiabetesSAFENCT01077570
An Observational Study Investigating the Safety and Effectiveness of Repaglinide in Chinese Patients
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in China.
Trial summary
This study is conducted in Asia. The aim of this observational study is, under normal clinical practice conditions, to investigate the clinical safety and effectiveness in Chinese patients with type 2 diabetes who have never received anti-diabetic treatment before. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- repaglinide
- How many people
- 2,033 participants
- Where
- 1 siteChina
- Study dates
- Mar 2010to Feb 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from both general and speciality practice settings who have been deemed appropriate to receive Repaglinide as initial treatment and as part of routine out-patient care by the prescribing physician.
Who may be able to join
- HbA1c more than 6.5%, no anti-diabetes treatment accepted before entering the study
Who cannot join
- Subjects who received any anti-diabetic treatment previously
- Known or suspected allergy to trial product(s) or related products.
- Subjects who previously enrolled in this study.
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Safety and Effectiveness of Repaglinide in Treatment-naive Type 2 Diabetes Subjects in China. A 16-week Multicentre, Prospective, Open Label, Non-interventional Study.
This study is conducted in Asia. The aim of this observational study is, under normal clinical practice conditions, to investigate the clinical safety and effectiveness in Chinese patients with type 2 diabetes who have never received anti-diabetic treatment before.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- repaglinide
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repaglinideDrug
Repaglinide prescribed at the discretion of the investigator, according to local labelling, and evaluated at week 0, 8 and 16 of the study
| Study group | Role | What they receive |
|---|---|---|
| Repaglinide | Not described Receives: Drug: repaglinide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of serious adverse drug reactions (SADRs) including major hypoglycaemic (low blood sugar) events
Measured: at Visit 2(8 weeks) and visit 3(16 weeks)
Secondary outcomes (5)
Number of minor hypoglycaemic (low blood sugar) episodes
Measured: at Visit 2(8 weeks) and visit 3(16 weeks)
Number of adverse drug reactions (ADRs)
Measured: at Visit 2(8 weeks) and visit 3(16 weeks)
Change in HbA1c
Measured: after 16 weeks of treatment
Change in fasting blood glucose (FBG)
Measured: after 8 and 16 weeks of treatment
Change in postprandial blood glucose (PBG)
Measured: after 8 and 16 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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
- 2,033 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077570
- Sponsor's protocol ID
- AGEE-3822
- Other IDs
- U1111-1112-6394
- Acronym
- SAFE
- Status last verified
- Jun 2014
- First submitted
- 26 Feb 2010
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Safety and Effectiveness of Repaglinide in Treatment-naive Type 2 Diabetes Subjects in China. A 16-week Multicentre, Prospective, Open Label, Non-interventional Study.
- ClinicalTrials.gov ID
- NCT01077570
- Acronym / sponsor ID
- SAFE / AGEE-3822
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,033 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 1 Mar 2010 (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 study is conducted in Asia. The aim of this observational study is, under normal clinical practice conditions, to investigate the clinical safety and effectiveness in Chinese patients with type 2 diabetes who have never received anti-diabetic treatment before.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Repaglinide | – | Drug: repaglinide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from both general and speciality practice settings who have been deemed appropriate to receive Repaglinide as initial treatment and as part of routine out-patient care by the prescribing physician.
Key inclusion criteria (1 listed)
- HbA1c more than 6.5%, no anti-diabetes treatment accepted before entering the study
Key exclusion criteria (4 listed)
- Subjects who received any anti-diabetic treatment previously
- Known or suspected allergy to trial product(s) or related products.
- Subjects who previously enrolled in this study.
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
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 |
|---|---|---|
| repaglinideRepaglinide prescribed at the discretion of the investigator, according to local labelling, and evaluated at week 0, 8 and 16 of the study | Drug | Repaglinide |
Primary outcome
Number of serious adverse drug reactions (SADRs) including major hypoglycaemic (low blood sugar) events
Time frame: at Visit 2(8 weeks) and visit 3(16 weeks)
5 secondary outcomes
Number of minor hypoglycaemic (low blood sugar) episodes
Time frame: at Visit 2(8 weeks) and visit 3(16 weeks)
Number of adverse drug reactions (ADRs)
Time frame: at Visit 2(8 weeks) and visit 3(16 weeks)
Change in HbA1c
Time frame: after 16 weeks of treatment
Change in fasting blood glucose (FBG)
Time frame: after 8 and 16 weeks of treatment
Change in postprandial blood glucose (PBG)
Time frame: after 8 and 16 weeks treatment
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 26 Jun 2014.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
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 and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S 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 4 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 26 Jun 2014. 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?
Number of serious adverse drug reactions (SADRs) including major hypoglycaemic (low blood sugar) events (time frame: at Visit 2(8 weeks) and visit 3(16 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 26 Jun 2014.