Diabetes Type 2Phase 4DMRNCT01354925
Management of Type-2 Diabetic Patients Treated With Insulin During the Ramadan
A Phase 4 study testing Insulin treatment during Ramadan in people with Diabetes Type 2 and Treatment During Ramadan, run by Meir Medical Center at 1 site in Israel.
Trial summary
Fasting during the Ramadan is one of the five pillars of Islam and is a mandatory duty for all healthy adult Muslims. Fasting is considered safe in young healthy subjects but it can induce harmful effects and complications in patients with diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 2, Treatment During Ramadan
- What is being tested?
- Insulin treatment during Ramadan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2011to Oct 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All of these criteria should be present.
- Patients with a diagnosis of type 2 diabetes treated with insulin (premix preparations or basal and rapid acting insulin) with or without metformin and/or a sulfonylurea drug for at least three months
- HbA1c in the past three months ≤ 10%
- Being capable, and willing, to perform self blood glucose monitoring and use a patient diary as required
- Age > 18 years
Who cannot join
- Any of the following:
- Patients with a diagnosis of type 1 diabetes
- Hypoglycemia unawareness
- Hypersensitivity to levemir
- Hypersensitivity to NovoMix70
- Creatinine > 2.5 mg/l
Show all 9Show fewer
- AST and or ALT > 1.5 times the upper limit
- Pregnancy
- Mental incapacity, unwillingness or language barrier precluding adequate understanding of the study protocol or cooperation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Type-2 Diabetic Patients Treated With Insulin During the Ramadan An Interventional, Community Based, Comparative Study
Fasting during the Ramadan is one of the five pillars of Islam and is a mandatory duty for all healthy adult Muslims. Fasting is considered safe in young healthy subjects but it can induce harmful effects and complications in patients with diabetes. Several studies have demonstrated that patients with type 2 diabetes are prone to hypo and hyper glycemia during fasting. When treating diabetic patients with a treatment guideline the rate of these complications can be reduced. Little data is available on patients with type 2 diabetes treated with insulin. The investigators therefore propose to assess the effect of a protocol containing detemir (levemir) and a premix of insulin aspart (NovoMix70) on glucose control in patients with type 2 diabetes during the Ramadan and to compare this regimen to the standard care patients receive during this period. The investigators assume that patients receiving the intervention will have better glucose control during the Ramadan compared to patients receiving the standard care. As approximately 45 million Muslims suffer from type 2 diabetes and most of them fast during the Ramadan the results of this intervention may be significant and may improve the care of these patients allowing Muslims to respect their religious obligations without compromising their health.
- Conditions
- Diabetes Type 2, Treatment During Ramadan
- Being tested
- Insulin treatment during Ramadan, Standard of care
- Keywords
- Diabetes type 2, Fasting, Ramadan, Insulin analogues
- Medical subject headings
- Diabetes Mellitus, Type 2, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin treatment during RamadanDrug
Insulin analogs will be used: Levemir and NovoMix70. The daily insulin dose will be calculated as follows: Sixty percent of the total daily dose will be used as the beginning daily dose at the first day of fasting. Sixty percent of the daily dose will be given as NovoMix70 before the Eftar (the main meal in the evening that breaks the fast). Forty percent of the amount will be given as Levemir (Early in the morning before the beginning of fasting.
Standard of careDrug
Standard of care during Ramadan according to physicians decision
| Study group | Role | What they receive |
|---|---|---|
| Insulin treatment during Ramadan | Active comparator | Insulin analogs will be used: Levemir and NovoMix70. . Receives: Drug: Insulin treatment during Ramadan |
| Standard treatment during Ramadan | Active comparator | Standard of care according to physicians choice Receives: Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean 4-point SMBG during days 23-30 of treatment between the two groups.
Measured: days 23-30 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Type 2Studies 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
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naim Shehadeh, MD, Principal investigator, Clalit HMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354925
- Sponsor's protocol ID
- MeirMc062/2011
- Acronym
- DMR
- Status last verified
- Apr 2013
- First submitted
- 16 May 2011
- Last updated
- 12 Apr 2013
- Results posted
- No
Publications
Shehadeh N, Maor Y; Ramadan Study Group. Effect of a new insulin treatment regimen on glycaemic control and quality of life of Muslim patients with type 2 diabetes mellitus during Ramadan fast - an open label, controlled, multicentre, cluster randomised study. Int J Clin Pract. 2015 Nov;69(11):1281-8. doi: 10.1111/ijcp.12695. Epub 2015 Jul 31.
PubMed 26234442
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Type-2 Diabetic Patients Treated With Insulin During the Ramadan An Interventional, Community Based, Comparative Study
- ClinicalTrials.gov ID
- NCT01354925
- Acronym / sponsor ID
- DMR / MeirMc062/2011
- Conditions
- Diabetes Type 2, Treatment During Ramadan
- Keywords
- Diabetes type 2, Fasting, Ramadan, Insulin analogues
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 17 May 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.
Fasting during the Ramadan is one of the five pillars of Islam and is a mandatory duty for all healthy adult Muslims. Fasting is considered safe in young healthy subjects but it can induce harmful effects and complications in patients with diabetes. Several studies have demonstrated that patients with type 2 diabetes are prone to hypo and hyper glycemia during fasting. When treating diabetic patients with a treatment guideline the rate of these complications can be reduced. Little data is available on patients with type 2 diabetes treated with insulin. The investigators therefore propose to assess the effect of a protocol containing detemir (levemir) and a premix of insulin aspart (NovoMix70) on glucose control in patients with type 2 diabetes during the Ramadan and to compare this regimen to the standard care patients receive during this period. The investigators assume that patients receiving the intervention will have better glucose control during the Ramadan compared to patients receiving the standard care. As approximately 45 million Muslims suffer from type 2 diabetes and most of them fast during the Ramadan the results of this intervention may be significant and may improve the care of these patients allowing Muslims to respect their religious obligations without compromising their health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin treatment during Ramadan | Active comparator | Drug: Insulin treatment during RamadanInsulin analogs will be used: Levemir and NovoMix70. . |
| Standard treatment during Ramadan | Active comparator | Drug: Standard of careStandard of care according to physicians choice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All of these criteria should be present.
- Patients with a diagnosis of type 2 diabetes treated with insulin (premix preparations or basal and rapid acting insulin) with or without metformin and/or a sulfonylurea drug for at least three months
- HbA1c in the past three months ≤ 10%
- Being capable, and willing, to perform self blood glucose monitoring and use a patient diary as required
- Age > 18 years
Key exclusion criteria (9 listed)
- Patients with a diagnosis of type 1 diabetes
- Hypoglycemia unawareness
- Hypersensitivity to levemir
- Hypersensitivity to NovoMix70
- Creatinine > 2.5 mg/l
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 |
|---|---|---|
| Insulin treatment during RamadanInsulin analogs will be used: Levemir and NovoMix70. The daily insulin dose will be calculated as follows: Sixty percent of the total daily dose will be used as the beginning daily dose at the first day of fasting. Sixty percent of the daily dose will be given as NovoMix70 before the Eftar (the main meal in the evening that breaks the fast). Forty percent of the amount will be given as Levemir (Early in the morning before the beginning of fasting. | Drug | Insulin treatment during Ramadan |
| Standard of careStandard of care during Ramadan according to physicians decision | Drug | Standard treatment during Ramadan |
Primary outcome
Difference in mean 4-point SMBG during days 23-30 of treatment between the two groups.
Time frame: days 23-30 of treatment
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 12 Apr 2013.
- Derived from this study: PubMed 26234442Shehadeh N, Maor Y; Ramadan Study Group. Effect of a new insulin treatment regimen on glycaemic control and quality of life of Muslim patients with type 2 diabetes mellitus during Ramadan fast - an open label, controlled, multicentre, cluster randomised study. Int J Clin Pract. 2015 Nov;69(11):1281-8. doi: 10.1111/ijcp.12695. Epub 2015 Jul 31.
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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.
Naim Shehadeh, MD principal investigator
Clalit HMO
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 Insulin treatment during Ramadan in people with Diabetes Type 2 and Treatment During Ramadan, run by Meir Medical Center at 1 site in Israel.
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 5 inclusion and 9 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 12 Apr 2013. 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 Israel. 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?
Difference in mean 4-point SMBG during days 23-30 of treatment between the two groups. (time frame: days 23-30 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01354925, which also lists 1 linked publication.
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 Apr 2013.