DiabetesPhase 4NCT01465152
Comparison of Metformin, Repaglinide or the Combination of Both in Subjects With Type 2 Diabetes
A Phase 4 study testing metformin and repaglinide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 18 sites in Spain.
Trial summary
This trial is conducted in Europe. The aim of this trial is to compare the efficacy of metformin and repaglinide used alone or combined administered as initial treatment in subjects with type 2 diabetes in which diet and exercise have failed. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- metformin and repaglinide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 18 sitesSpain
- Study dates
- 6 Mar 2002to 21 Oct 2004
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with type 2 diabetes
- Treated by diet for at least 3 months
- Never treated with hypoglycaemic drugs
- HbA1c (glycaemic haemoglobin A1c) on inclusion time superior to 6.5%
Who cannot join
- Very symptomatic diabetes
- Advanced vascular complications
- Manifest renal failure
- Manifest hepatic disease
- Pregnancy, breast feeding or intention to become pregnant or if it is considered that the patient is not using adequate contraceptive measures. Adequate contraceptive measures are considered to be an intrauterine device, oral contraceptives and barrier methods
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Spain18 sites
Novo Nordisk Investigational Site
Barcelona, 08020
Novo Nordisk Investigational Site
Benamargosa, 29718
Novo Nordisk Investigational Site
Burlata, 31600
Novo Nordisk Investigational Site
Camas, 41900
Novo Nordisk Investigational Site
Fuenlabrada, 28942
Novo Nordisk Investigational Site
Gijón, 33212
Novo Nordisk Investigational Site
Granada, 18012
Novo Nordisk Investigational Site
Lugo, 27004
Novo Nordisk Investigational Site
Madrid, 28021
Novo Nordisk Investigational Site
Madrid, 28030
Novo Nordisk Investigational Site
Madrid, 28035
Novo Nordisk Investigational Site
Portugalete, 48920
Novo Nordisk Investigational Site
San Adria Del Besos, 08930
Novo Nordisk Investigational Site
Santander, 39009
Novo Nordisk Investigational Site
Santander, 39011
Novo Nordisk Investigational Site
Tegueste, 38280
Novo Nordisk Investigational Site
Valencia, 46021
Novo Nordisk Investigational Site
Zaragoza, 50007
About this study
Official title: Multicentre, Randomised, Comparative, Open, Three Armed Parallel Group Study on the Use of Metformin, Repaglinide or the Combination of Both in Type 2 Diabetic Patients After Failure of Dietary Measures
This trial is conducted in Europe. The aim of this trial is to compare the efficacy of metformin and repaglinide used alone or combined administered as initial treatment in subjects with type 2 diabetes in which diet and exercise have failed.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- metformin, 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.
metforminDrug
Adminstered orally during the three main meals for 24 weeks
repaglinideDrug
Administered orally before the three main meals for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Met | Experimental | Not described Receives: Drug: metformin |
| Rep | Active comparator | Not described Receives: Drug: repaglinide |
| Met+Rep | Active comparator | Not described Receives: Drug: metformin; Drug: repaglinide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of % HbA1c (glycosylated haemoglobin) in blood
Secondary outcomes (6)
Change of the mean body mass index calculated as weight in kilograms divided by the square of height in metres
Incidence of clinical and/or biochemistry hypoglycaemia episodes
Incidence of adverse events
Presence of laboratory abnormalities in routine blood analyses
Change of the blood pressure and/or heart rate
Treatment compliance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study start6 Mar 2002
- Primary completion21 Oct 2004
- Study completion21 Oct 2004
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
- 182 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
- NCT01465152
- Sponsor's protocol ID
- AGEE-1411
- Status last verified
- Feb 2017
- First submitted
- 31 Oct 2011
- 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
- Multicentre, Randomised, Comparative, Open, Three Armed Parallel Group Study on the Use of Metformin, Repaglinide or the Combination of Both in Type 2 Diabetic Patients After Failure of Dietary Measures
- ClinicalTrials.gov ID
- NCT01465152
- Acronym / sponsor ID
- AGEE-1411
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2002 (actual)
- Primary completion
- 21 Oct 2004 (actual)
- Study completion
- 21 Oct 2004 (actual)
- First posted
- 4 Nov 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 Europe. The aim of this trial is to compare the efficacy of metformin and repaglinide used alone or combined administered as initial treatment in subjects with type 2 diabetes in which diet and exercise have failed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Met | Experimental | Drug: metformin |
| Rep | Active comparator | Drug: repaglinide |
| Met+Rep | Active comparator | Drug: metformin, Drug: repaglinide |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with type 2 diabetes
- Treated by diet for at least 3 months
- Never treated with hypoglycaemic drugs
- HbA1c (glycaemic haemoglobin A1c) on inclusion time superior to 6.5%
Key exclusion criteria (5 listed)
- Very symptomatic diabetes
- Advanced vascular complications
- Manifest renal failure
- Manifest hepatic disease
- Pregnancy, breast feeding or intention to become pregnant or if it is considered that the patient is not using adequate contraceptive measures. Adequate contraceptive measures are considered to be an intrauterine device, oral contraceptives and barrier 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 |
|---|---|---|
| metforminAdminstered orally during the three main meals for 24 weeks | Drug | Met, Met+Rep |
| repaglinideAdministered orally before the three main meals for 24 weeks | Drug | Met+Rep, Rep |
Primary outcome
Change of % HbA1c (glycosylated haemoglobin) in blood
6 secondary outcomes
Change of the mean body mass index calculated as weight in kilograms divided by the square of height in metres
Incidence of clinical and/or biochemistry hypoglycaemia episodes
Incidence of adverse events
Presence of laboratory abnormalities in routine blood analyses
Change of the blood pressure and/or heart rate
Treatment compliance
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
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing metformin and repaglinide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 18 sites in Spain.
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 5 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 18 sites in Spain. 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?
Change of % HbA1c (glycosylated haemoglobin) in blood. 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.