DiabetesPhase 4NCT00568984
Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes
A Phase 4 study testing repaglinide, metformin and glicazide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 15 sites in 4 countries.
Trial summary
This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of blood glucose control with combination therapy of repaglinide and metformin compared to conventional treatment with a sulphonylurea or metformin in monotherapy in type 2 diabetes Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- repaglinide, metformin and glicazide
- How many people
- 324 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 21 Nov 2002to 10 Nov 2003
- Phase
- Phase 4
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes for at least 3 months
- No previous treatment for diabetes
- HbA1c between 7.0-12.0%
- Body Mass Index (BMI) between 19.0-40.0 kg/m2
Who cannot join
- Type 1 diabetes
- Known unstable/untreated proliferative retinopathy
- Uncontrolled treated/untreated hypertension
- Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
Philippines6 sites
Novo Nordisk Investigational Site
Cebu City, 6000
Novo Nordisk Investigational Site
Manila, 1003
Novo Nordisk Investigational Site
Marikina City, 1800
Novo Nordisk Investigational Site
Pampanga, 2000
Novo Nordisk Investigational Site
Quezon, 4301
Novo Nordisk Investigational Site
Quezon City, 1100
China4 sites
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100034
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100044
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100730
Novo Nordisk Investigational Site
Tianjin, Tianjin Municipality, 300052
Malaysia3 sites
Novo Nordisk Investigational Site
Cheras, 56000
Novo Nordisk Investigational Site
Ipoh, 30450
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, 16150
Thailand2 sites
Novo Nordisk Investigational Site
Bangkok, 10300
Novo Nordisk Investigational Site
Bangkok, 10330
About this study
Official title: Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes Mellitus
This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of blood glucose control with combination therapy of repaglinide and metformin compared to conventional treatment with a sulphonylurea or metformin in monotherapy in type 2 diabetes
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- repaglinide, metformin, glicazide
- 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
metforminDrug
glicazideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: after 16 weeks of treatment
Secondary outcomes (5)
Glucose profiles
Quality of life assessment
Treatment satisfaction
Hypoglycaemic events
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study start21 Nov 2002
- Primary completion10 Nov 2003
- Study completion10 Nov 2003
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 324 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
- NCT00568984
- Sponsor's protocol ID
- AGEE-3017
- Status last verified
- Feb 2017
- First submitted
- 4 Dec 2007
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00568984
- Acronym / sponsor ID
- AGEE-3017
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2002 (actual)
- Primary completion
- 10 Nov 2003 (actual)
- Study completion
- 10 Nov 2003 (actual)
- First posted
- 6 Dec 2007 (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 aim of this trial is to investigate the efficacy of blood glucose control with combination therapy of repaglinide and metformin compared to conventional treatment with a sulphonylurea or metformin in monotherapy in type 2 diabetes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes for at least 3 months
- No previous treatment for diabetes
- HbA1c between 7.0-12.0%
- Body Mass Index (BMI) between 19.0-40.0 kg/m2
Key exclusion criteria (4 listed)
- Type 1 diabetes
- Known unstable/untreated proliferative retinopathy
- Uncontrolled treated/untreated hypertension
- Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures
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 |
|---|---|---|
| repaglinide | Drug | – |
| metformin | Drug | – |
| glicazide | Drug | – |
Primary outcome
HbA1c
Time frame: after 16 weeks of treatment
5 secondary outcomes
Glucose profiles
Quality of life assessment
Treatment satisfaction
Hypoglycaemic events
Adverse events
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 20 Feb 2017.
- 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
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing repaglinide, metformin and glicazide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 15 sites in 4 countries.
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 4 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 20 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Philippines, China, Malaysia, Thailand. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
HbA1c (time frame: after 16 weeks of treatment). 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 20 Feb 2017.