Type 2 DiabetesPhase 4T4RNCT02292290
Trial for People With Established Type 2 Diabetes During Ramadan
A Phase 4 study testing Liraglutide, Sulfonylurea or Pioglitazone and Maintain dual therapy (Sulf/Pio) as comparator to Liraglutide in people with Type 2 Diabetes, run by University of Leicester at 2 sites in United Kingdom.
Trial summary
Dual therapy with metformin and Liraglutide is more effective at helping people with established Type 2 Diabetes Mellitus (T2DM) observing Ramadan achieve a triple composite endpoint of weight reduction and/or maintenance and improved HaemaglobinA1c (HbA1c) and no severe hypoglycaemic events. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Liraglutide, Sulfonylurea or Pioglitazone and Maintain dual therapy (Sulf/Pio) as comparator to Liraglutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2011to Dec 2012
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals ≥ 18 years old with established T2DM on metformin only
- or dual therapy of metformin plus a sulphonylurea or pioglitazone
- with a HbA1c between 7 - 11 % if on monotherapy and between 6.5 - 12% if on dual therapy
Who cannot join
- Are pregnant or breast feeding
- Suffer from terminal illness
- Have significant renal or liver impairment
- Are unable to provide informed consent
- Have severe and enduring mental health problems
- Are not primarily responsible for their own care
- Are receiving insulin therapy
- Type 1 diabetes
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University Hospital Birmingham
Birmingham, West Midlands
University Hospitals of Leicester
Leicester, Leicestershire
About this study
Official title: A Randomised Controlled Trial for People With Established Type 2 Diabetes During Ramadan: Liraglutide vs. a Sulphonylurea
Dual therapy with metformin and Liraglutide is more effective at helping people with established Type 2 Diabetes Mellitus (T2DM) observing Ramadan achieve a triple composite endpoint of weight reduction and/or maintenance and improved HaemaglobinA1c (HbA1c) and no severe hypoglycaemic events.
Read the detailed description
Participants in the control arm will essentially continue with their standard routine care and those in the intervention groups will either receive Liraglutide in addition to metformin or those on dual therapy will switch from their sulphonylurea/pioglitazone to Liraglutide and continue with metformin. Informed consent and baseline data will be collected 4-8 weeks prior to the start of Ramadan. This will allow time for a run in period for the titration of Liraglutide prior to the fasting period. Ramadan is followed by Eid-al-Fitr a 3-day Islamic holiday that marks the end of this holy month. Tradition includes amongst early morning prayers/celebration through feasting. Therefore, participants will be invited to attend the first follow-up after this event (between weeks 2 - 4) and then at 12 weeks post Ramadan. Randomisation will not be revealed until after the baseline data have been collected.
- Conditions
- Type 2 Diabetes
- Being tested
- Liraglutide, Sulfonylurea or Pioglitazone, Maintain dual therapy (Sulf/Pio) as comparator to Liraglutide
- Keywords
- Diabetes, Liraglutide, Ramadan, fasting
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Victoza
4 week lead-in 0.6mg Liraglutide OD up to 1.2mg OD after 2 weeks if poor response
LiraglutideDrug
Also called Victoza
4 week lead-in 0.6mg Liraglutide OD up to 1.2mg after two weeks if poor response.
Sulfonylurea or PioglitazoneDrug
Addition to Metformin
Maintain dual therapy (Sulf/Pio) as comparator to LiraglutideDrug
As per clinical guidelines for prescription
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy 2 | Active comparator | addition of Sulfonylurea or Pioglitazone to Metformin Receives: Drug: Sulfonylurea or Pioglitazone |
| Dual Therapy 1 | Experimental | Swap Liraglutide for sulfonylurea or pioglitazone taken as second line therapy (Metformin) first line) Receives: Drug: Liraglutide |
| Dual therapy 2 | Active comparator | Maintain sulfonylurea or pioglitazone as second line therapy (Metformin first line) Receives: Drug: Maintain dual therapy (Sulf/Pio) as comparator to Liraglutide |
| Monotherapy | Experimental | Addition of Liraglutide to Metformin Receives: Drug: Liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite
A composite endpoint of a reduction in weight, reduction/maintenance of HbA1c and elimination of severe hypoglycaemic (defined as hospital admission) events post intervention.
Measured: 12 weeks following post Ramadan cinical assessment
Secondary outcomes (1)
HbA1c only
Mean change HbA1c level
Measured: same as primary, 12 weeks following post Ramadan cinical assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startApr 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester, University Hospital Birmingham
- Responsible party
- Sponsor
- Investigators
- Melanie J D, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292290
- Sponsor's protocol ID
- 0207
- Acronym
- T4R
- Status last verified
- Aug 2012
- First submitted
- 16 Jan 2011
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial for People With Established Type 2 Diabetes During Ramadan: Liraglutide vs. a Sulphonylurea
- ClinicalTrials.gov ID
- NCT02292290
- Acronym / sponsor ID
- T4R / 0207
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, Liraglutide, Ramadan, fasting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester, University Hospital Birmingham
- Study start
- Apr 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Nov 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.
Dual therapy with metformin and Liraglutide is more effective at helping people with established Type 2 Diabetes Mellitus (T2DM) observing Ramadan achieve a triple composite endpoint of weight reduction and/or maintenance and improved HaemaglobinA1c (HbA1c) and no severe hypoglycaemic events.
Detailed description
Participants in the control arm will essentially continue with their standard routine care and those in the intervention groups will either receive Liraglutide in addition to metformin or those on dual therapy will switch from their sulphonylurea/pioglitazone to Liraglutide and continue with metformin. Informed consent and baseline data will be collected 4-8 weeks prior to the start of Ramadan. This will allow time for a run in period for the titration of Liraglutide prior to the fasting period. Ramadan is followed by Eid-al-Fitr a 3-day Islamic holiday that marks the end of this holy month. Tradition includes amongst early morning prayers/celebration through feasting. Therefore, participants will be invited to attend the first follow-up after this event (between weeks 2 - 4) and then at 12 weeks post Ramadan. Randomisation will not be revealed until after the baseline data have been collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Monotherapy 2 | Active comparator | Drug: Sulfonylurea or Pioglitazoneaddition of Sulfonylurea or Pioglitazone to Metformin |
| Dual Therapy 1 | Experimental | Drug: LiraglutideSwap Liraglutide for sulfonylurea or pioglitazone taken as second line therapy (Metformin) first line) |
| Dual therapy 2 | Active comparator | Drug: Maintain dual therapy (Sulf/Pio) as comparator to LiraglutideMaintain sulfonylurea or pioglitazone as second line therapy (Metformin first line) |
| Monotherapy | Experimental | Drug: LiraglutideAddition of Liraglutide to Metformin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals ≥ 18 years old with established T2DM on metformin only
- or dual therapy of metformin plus a sulphonylurea or pioglitazone
- with a HbA1c between 7 - 11 % if on monotherapy and between 6.5 - 12% if on dual therapy
Key exclusion criteria (8 listed)
- Are pregnant or breast feeding
- Suffer from terminal illness
- Have significant renal or liver impairment
- Are unable to provide informed consent
- Have severe and enduring mental health problems
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 |
|---|---|---|
| LiraglutideAlso: Victoza4 week lead-in 0.6mg Liraglutide OD up to 1.2mg OD after 2 weeks if poor response | Drug | Monotherapy |
| LiraglutideAlso: Victoza4 week lead-in 0.6mg Liraglutide OD up to 1.2mg after two weeks if poor response. | Drug | Dual Therapy 1 |
| Sulfonylurea or PioglitazoneAddition to Metformin | Drug | Monotherapy 2 |
| Maintain dual therapy (Sulf/Pio) as comparator to LiraglutideAs per clinical guidelines for prescription | Drug | Dual therapy 2 |
Primary outcome
Composite
Time frame: 12 weeks following post Ramadan cinical assessment
A composite endpoint of a reduction in weight, reduction/maintenance of HbA1c and elimination of severe hypoglycaemic (defined as hospital admission) events post intervention.
1 secondary outcome
HbA1c only
Time frame: same as primary, 12 weeks following post Ramadan cinical assessment
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 30 Jan 2020.
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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.
Melanie J D principal investigator
University of Leicester
2 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 Liraglutide, Sulfonylurea or Pioglitazone and Maintain dual therapy (Sulf/Pio) as comparator to Liraglutide in people with Type 2 Diabetes, run by University of Leicester at 2 sites in United Kingdom.
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 3 inclusion and 8 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 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Composite (time frame: 12 weeks following post Ramadan cinical assessment). 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 30 Jan 2020.