DiabetesNCT01355718
Observational, Safety Study of NovoNorm® (Repaglinide) and Insulin Analogue Combination Therapy in Type 2 Diabetes in Korea
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in South Korea.
Trial summary
This trial is conducted in Asia. The primary objective of this study is to evaluate the clinical safety profile during 26 weeks of NovoNorm® (repaglinide) and insulin analogue combination therapy in type 2 diabetes under normal clinical practice conditions in Korea while the secondary objective is to evaluate the… 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
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Mar 2013
- 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 who are currently treated with NovoNorm® alone or in combination with metformin or TZD (thiazolidinedione) and will be additionally prescribed with insulin analogue at the discretion of the physicians will be eligible for this study.
Who may be able to join
- Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol.)
- Patients with type 2 diabetes mellitus
- Patients who are currently treated with NovoNorm® alone or in combination with metformin or TZD
- Age: at least 18 years old
- Patients who will be prescribed with insulin analogue in addition to current NovoNorm® (with/without metformin/TZD) treatment at the discretion by the Physician
Who cannot join
- Known or suspected allergy to study product(s) or related products
- Previous participation in this study. Participation is defined as screened
- Patients who have been treated with insulin preparations (including insulin analogues) previously
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
- Patients who are unlikely to comply with protocol requirements, e.g. uncooperative attitude, inability to return for the final visit
- Any other disease or condition that the Physician feels would interfere with study participation or evaluation of results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 26-week, Multicentre, Open-labelled, Non-randomised, Non-interventional, Observational, Safety Study of NovoNorm® (Repaglinide) and Insulin Analogue Combination Therapy in Type 2 Diabetes in Korea
This trial is conducted in Asia. The primary objective of this study is to evaluate the clinical safety profile during 26 weeks of NovoNorm® (repaglinide) and insulin analogue combination therapy in type 2 diabetes under normal clinical practice conditions in Korea while the secondary objective is to evaluate the safety and efficacy after 13 and 26 weeks of NovoNorm® and insulin analogue combination therapy in type 2 diabetes under normal clinical practice conditions in Korea.
- 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
The dosage and frequency, as well as later changes to either dose, frequency or add-on medication (if applicable), will be determined by the physician, according to the patient's requirements.
| 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.
Incidence of serious Adverse Drug Reactions (SADRs) including major (serious) hypoglycaemic episodes
Measured: weeks 0-26
Secondary outcomes (4)
Incidence of Adverse Drug Reactions (ADRs)
Measured: week 13 and 26
Incidence of Adverse Events (AEs)
Measured: week 13 and 26
Incidence of Serious Adverse Event (SAEs)
Measured: week 13 and 26
Change in HbA1c
Measured: after 13 and 26 weeks of NovoNorm® and insulin analogue combination therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2013
- Study completionMar 2013
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
- 120 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
- NCT01355718
- Sponsor's protocol ID
- AGEE-3905
- Other IDs
- U1111-1119-9152
- Status last verified
- Aug 2014
- First submitted
- 13 May 2011
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 26-week, Multicentre, Open-labelled, Non-randomised, Non-interventional, Observational, Safety Study of NovoNorm® (Repaglinide) and Insulin Analogue Combination Therapy in Type 2 Diabetes in Korea
- ClinicalTrials.gov ID
- NCT01355718
- Acronym / sponsor ID
- AGEE-3905
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 18 May 2011 (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 trial is conducted in Asia. The primary objective of this study is to evaluate the clinical safety profile during 26 weeks of NovoNorm® (repaglinide) and insulin analogue combination therapy in type 2 diabetes under normal clinical practice conditions in Korea while the secondary objective is to evaluate the safety and efficacy after 13 and 26 weeks of NovoNorm® and insulin analogue combination therapy in type 2 diabetes under normal clinical practice conditions in Korea.
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 who are currently treated with NovoNorm® alone or in combination with metformin or TZD (thiazolidinedione) and will be additionally prescribed with insulin analogue at the discretion of the physicians will be eligible for this study.
Key inclusion criteria (5 listed)
- Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol.)
- Patients with type 2 diabetes mellitus
- Patients who are currently treated with NovoNorm® alone or in combination with metformin or TZD
- Age: at least 18 years old
- Patients who will be prescribed with insulin analogue in addition to current NovoNorm® (with/without metformin/TZD) treatment at the discretion by the Physician
Key exclusion criteria (6 listed)
- Known or suspected allergy to study product(s) or related products
- Previous participation in this study. Participation is defined as screened
- Patients who have been treated with insulin preparations (including insulin analogues) previously
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
- Patients who are unlikely to comply with protocol requirements, e.g. uncooperative attitude, inability to return for the final visit
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 |
|---|---|---|
| repaglinideThe dosage and frequency, as well as later changes to either dose, frequency or add-on medication (if applicable), will be determined by the physician, according to the patient's requirements. | Drug | Repaglinide |
Primary outcome
Incidence of serious Adverse Drug Reactions (SADRs) including major (serious) hypoglycaemic episodes
Time frame: weeks 0-26
4 secondary outcomes
Incidence of Adverse Drug Reactions (ADRs)
Time frame: week 13 and 26
Incidence of Adverse Events (AEs)
Time frame: week 13 and 26
Incidence of Serious Adverse Event (SAEs)
Time frame: week 13 and 26
Change in HbA1c
Time frame: after 13 and 26 weeks of NovoNorm® and insulin analogue combination therapy
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 11 Aug 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 South Korea.
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 5 inclusion and 6 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 11 Aug 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 South Korea. 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?
Incidence of serious Adverse Drug Reactions (SADRs) including major (serious) hypoglycaemic episodes (time frame: weeks 0-26). 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 11 Aug 2014.