Type 2 Diabetes MellitusZODIAC-39NCT02133118
Weight Trajectory in New Users of Sulfonylureas as Add on Therapy Next to Metformin.
An observational study of Type 2 Diabetes Mellitus, run by Medical Research Foundation, The Netherlands at 1 site in Netherlands.
Trial summary
Next to HbA1c, body weight is regarded as an important surrogate end-point in trials investigating glucose-lowering agents. An increase in weight could contribute to worsening insulin resistance. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- individual SUs, insulin, pioglitazone
- How many people
- 16,293 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 1998to Dec 2014
- How long will I take part?
- 5 Years
- 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: Patients with T2DM who received monotherapy with metformin and needed treatment intensification by receiving add-on therapy next to metformin
Who may be able to join
- T2DM
- Treated in primary care in period 1998 to 2012
- used metformin monotherapy
- subsequently received add-on therapy with a SU or pioglitazone during their entire follow-up period
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Observational Cohort Study; The Weight Trajectory in New Users of Sulfonylureas as Add on Therapy Next to Metformin.
Next to HbA1c, body weight is regarded as an important surrogate end-point in trials investigating glucose-lowering agents. An increase in weight could contribute to worsening insulin resistance. Differences in weight after starting glucose lowering agents have been described in many randomized controlled trials (RCTs).
With this prospective observational study, weight trajectories after receiving add-on therapy next to metformin are evaluated in primary care patients with good glycaemic control.
Read the detailed description
This prospective cohort study is part of the ZODIAC (Zwolle Outpatient Diabetes project Integrating Available Care) study, which started in 1998 as a prospective observational study and includes patients with known T2DM who are treated in primary care.
The investigators aim to investigate the course of the bodyweight and glycaemic control, the years after starting specific SU's, pioglitazone or insulin as add-on therapy, in metformin treated primary care patients with T2DM.
As part of the process called benchmarking, a dataset of quality measures is collected annually for all patients participating in the ZODIAC study during the patient's visit to the practice nurse and/or general practitioner and sent to the investigators' diabetes centre for benchmarking and research purposes once a year.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- individual SUs, insulin, pioglitazone
- Keywords
- Type 2 diabetes, New-user design, Weight trajectory, Add-on therapy, Sulphonylureas.
- Medical subject headings
- Diabetes Mellitus, Type 2, Body-Weight Trajectory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individual SUs, insulin, pioglitazoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Patients on metformin mono-therapy who receive add-on | Not described Receives: Drug: individual SUs, insulin, pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The course of weight (Kg) after starting individual SU's, pioglitazone or insulin as add-on therapy.
The course of the bodyweight up to five years after starting individual SU's (gliclazide/glibenclamide/tolbutamide/glimepiride), pioglitazone or insulin as add-on therapy, in metformin treated primary care patients with T2DM.
Measured: Up to 5 years
Secondary outcomes (1)
The course of the glycaemic control (HbA1c %) , up to five years after starting individual SU's, pioglitazone or insulin as add-on therapy.
The course of the glycaemic control, up to five years after starting individual SU's (gliclazide, glibenclamide, tolbutamide, glimepiride), pioglitazone or insulin as add-on therapy, in metformin treated primary care patients with T2DM.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startJan 1998
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- 16,293 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Medical Research Foundation, The Netherlands
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gijs Landman, Medical Research Foundation, The Netherlands
- Investigators
- G. W.D. Landman, MD PhD, Principal investigator, Isala, Diabetes CentreR. Wever, MD, Principal investigator, Isala, Diabetes CentreP. R. van Dijk, MD, Principal investigator, Isala, Diabetes CentreNanne Kleefstra, MD PhD, Study director, Diabetes Centre, Isala, Zwolle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133118
- Sponsor's protocol ID
- ZODIAC
- Acronym
- ZODIAC-39
- Status last verified
- Mar 2015
- First submitted
- 6 May 2014
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study; The Weight Trajectory in New Users of Sulfonylureas as Add on Therapy Next to Metformin.
- ClinicalTrials.gov ID
- NCT02133118
- Acronym / sponsor ID
- ZODIAC-39 / ZODIAC
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes, New-user design, Weight trajectory, Add-on therapy, Sulphonylureas.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16,293 participants (actual)
- Lead sponsor
- Medical Research Foundation, The NetherlandsUniversity, hospital or other
- Study start
- Jan 1998
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 May 2014 (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.
Next to HbA1c, body weight is regarded as an important surrogate end-point in trials investigating glucose-lowering agents. An increase in weight could contribute to worsening insulin resistance. Differences in weight after starting glucose lowering agents have been described in many randomized controlled trials (RCTs).
With this prospective observational study, weight trajectories after receiving add-on therapy next to metformin are evaluated in primary care patients with good glycaemic control.
Detailed description
This prospective cohort study is part of the ZODIAC (Zwolle Outpatient Diabetes project Integrating Available Care) study, which started in 1998 as a prospective observational study and includes patients with known T2DM who are treated in primary care.
The investigators aim to investigate the course of the bodyweight and glycaemic control, the years after starting specific SU's, pioglitazone or insulin as add-on therapy, in metformin treated primary care patients with T2DM.
As part of the process called benchmarking, a dataset of quality measures is collected annually for all patients participating in the ZODIAC study during the patient's visit to the practice nurse and/or general practitioner and sent to the investigators' diabetes centre for benchmarking and research purposes once a year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients on metformin mono-therapy who receive add-on | – | Drug: individual SUs, insulin, pioglitazone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with T2DM who received monotherapy with metformin and needed treatment intensification by receiving add-on therapy next to metformin
Key inclusion criteria (4 listed)
- T2DM
- Treated in primary care in period 1998 to 2012
- used metformin monotherapy
- subsequently received add-on therapy with a SU or pioglitazone during their entire follow-up period
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| individual SUs, insulin, pioglitazone | Drug | Patients on metformin mono-therapy who receive add-on |
Primary outcome
The course of weight (Kg) after starting individual SU's, pioglitazone or insulin as add-on therapy.
Time frame: Up to 5 years
The course of the bodyweight up to five years after starting individual SU's (gliclazide/glibenclamide/tolbutamide/glimepiride), pioglitazone or insulin as add-on therapy, in metformin treated primary care patients with T2DM.
1 secondary outcome
The course of the glycaemic control (HbA1c %) , up to five years after starting individual SU's, pioglitazone or insulin as add-on therapy.
Time frame: Up to 5 years
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 17 Mar 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.
G. W.D. Landman, MD PhD principal investigator
Isala, Diabetes Centre
R. Wever, MD principal investigator
Isala, Diabetes Centre
P. R. van Dijk, MD principal investigator
Isala, Diabetes Centre
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 Type 2 Diabetes Mellitus, run by Medical Research Foundation, The Netherlands at 1 site in Netherlands.
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 0 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 17 Mar 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 Netherlands. 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?
The course of weight (Kg) after starting individual SU's, pioglitazone or insulin as add-on therapy. (time frame: Up to 5 years). 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 17 Mar 2015.