DiabetesPhase 4NCT00766441
Sitagliptin Versus Sulphonylurea in Type 2 Diabetes During Ramadan
A Phase 4 study testing Sitagliptin and sulphonylurea in people with Diabetes and Hypoglycemia, run by University of Manchester at 1 site in United Kingdom.
Trial summary
This study will assess if Sitagliptin addition to metformin or glitazone is better than current sulphonylurea based treatments during Ramadan. The rationale is that Sitagliptin offers metabolic advantages primarily with the low incidence of hypoglycemia over current sulphonylurea based treatments. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Diabetes, Hypoglycemia
- What is being tested?
- Sitagliptin and sulphonylurea
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2008to Oct 2009
- 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 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Muslim men and women with Type 2 diabetes.
- Age 18-78 years
- Intending to fast during the month of Ramadan
- On oral antihyperglycemic agents (sulphonylurea based/combination therapy)
Who cannot join
- Patient with hypersensitivity or contraindication to Sitagliptin treatment
- Patient with CKD (creatinine clearance <50 ml/min)
- Patients who have participated in another intervention study in the last 2 months
- Patients who do not give informed consent
- Pregnant or breast feeding women.
- Patients on insulin
- Patients with severe liver disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wellcome Trust Clinical Research Facility
Manchester, M13 9NT
About this study
Official title: Sitagliptin Versus Sulphonylurea Based Treatments in Muslim Patients With Type 2 Diabetes During Ramadan
This study will assess if Sitagliptin addition to metformin or glitazone is better than current sulphonylurea based treatments during Ramadan. The rationale is that Sitagliptin offers metabolic advantages primarily with the low incidence of hypoglycemia over current sulphonylurea based treatments.
Read the detailed description
To define metabolic alterations during Ramadan:
- Primary end point: Occurrence of hypoglycemia. The patients will record hypoglycaemic episodes in a self-monitoring diary together with blood glucose values.
- Secondary endpoints: Body weight, fasting blood sugar (FBS), glycosylated haemoglobin (HbA1c)/Fructosamine, triglycerides (TG), total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C) and high density lipoprotein-cholesterol (HDL-C).
- A subgroup will undergo CGMS assessment to define glycaemic excursions during and after fasting.
- Conditions
- Diabetes, Hypoglycemia
- Being tested
- Sitagliptin, sulphonylurea
- Keywords
- diabetes, hypoglycemia, ramadan, fasting
- Medical subject headings
- Diabetes Mellitus, Hypoglycemia, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
tablet, 100mg, once daily, 4 weeks
sulphonylureaDrug
sulphonylurea, variable, od or bd, during ramadan
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Sitagliptin 100mg Receives: Drug: Sitagliptin |
| 2 | Active comparator | Sulphonylurea Receives: Drug: sulphonylurea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of hypoglycemia
Measured: 4 weeks during Ramadan
Secondary outcomes (1)
Body weight, fasting blood sugar, HbA1c, triglycerides, total cholesterol, LDL-C, HDL-C. CGMS to define glycaemic excursions
Measured: 4 weeks during Ramadan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: inadequate recruitment
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 University of ManchesterThe 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Investigators
- Rayaz A Malik, MBChB, PhD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766441
- Sponsor's protocol ID
- 08/H1005/46
- Status last verified
- Oct 2008
- First submitted
- 3 Oct 2008
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sitagliptin Versus Sulphonylurea Based Treatments in Muslim Patients With Type 2 Diabetes During Ramadan
- ClinicalTrials.gov ID
- NCT00766441
- Acronym / sponsor ID
- 08/H1005/46
- Conditions
- Diabetes, Hypoglycemia
- Keywords
- diabetes, hypoglycemia, ramadan, fasting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inadequate recruitment
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 6 Oct 2008 (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 study will assess if Sitagliptin addition to metformin or glitazone is better than current sulphonylurea based treatments during Ramadan. The rationale is that Sitagliptin offers metabolic advantages primarily with the low incidence of hypoglycemia over current sulphonylurea based treatments.
Detailed description
To define metabolic alterations during Ramadan:
- Primary end point: Occurrence of hypoglycemia. The patients will record hypoglycaemic episodes in a self-monitoring diary together with blood glucose values.
- Secondary endpoints: Body weight, fasting blood sugar (FBS), glycosylated haemoglobin (HbA1c)/Fructosamine, triglycerides (TG), total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C) and high density lipoprotein-cholesterol (HDL-C).
- A subgroup will undergo CGMS assessment to define glycaemic excursions during and after fasting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: SitagliptinSitagliptin 100mg |
| 2 | Active comparator | Drug: sulphonylureaSulphonylurea |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Muslim men and women with Type 2 diabetes.
- Age 18-78 years
- Intending to fast during the month of Ramadan
- On oral antihyperglycemic agents (sulphonylurea based/combination therapy)
Key exclusion criteria (7 listed)
- Patient with hypersensitivity or contraindication to Sitagliptin treatment
- Patient with CKD (creatinine clearance <50 ml/min)
- Patients who have participated in another intervention study in the last 2 months
- Patients who do not give informed consent
- Pregnant or breast feeding women.
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 |
|---|---|---|
| Sitagliptintablet, 100mg, once daily, 4 weeks | Drug | 1 |
| sulphonylureasulphonylurea, variable, od or bd, during ramadan | Drug | 2 |
Primary outcome
Occurrence of hypoglycemia
Time frame: 4 weeks during Ramadan
1 secondary outcome
Body weight, fasting blood sugar, HbA1c, triglycerides, total cholesterol, LDL-C, HDL-C. CGMS to define glycaemic excursions
Time frame: 4 weeks during Ramadan
Results and safety
The study was stopped early (reason given: inadequate recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
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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.
Rayaz A Malik, MBChB, PhD principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sitagliptin and sulphonylurea in people with Diabetes and Hypoglycemia, run by University of Manchester at 1 site 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 12 Jan 2010. 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 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 was stopped early (reason given: inadequate recruitment). Results are not available in the source record.
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?
Occurrence of hypoglycemia (time frame: 4 weeks during Ramadan). 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 12 Jan 2010.