Management of Type-2 Diabetic Patients Treated With Insulin During the Ramadan

Study Overview
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Brief Summary
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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.

Official Title
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Management of Type-2 Diabetic Patients Treated With Insulin During the Ramadan An Interventional, Community Based, Comparative Study

Conditions
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Diabetes Type 2, Treatment During Ramadan

Intervention / Treatment
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* Drug: Insulin treatment during Ramadan
* Drug: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Insulin treatment during Ramadan<br>Insulin analogs will be used: Levemir and NovoMix70. . | Drug: Insulin treatment during Ramadan<br>* 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.<br>|
| Active Comparator: Standard treatment during Ramadan<br>Standard of care according to physicians choice | Drug: Standard of care<br>* Standard of care during Ramadan according to physicians decision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in mean 4-point SMBG during days 23-30 of treatment between the two groups. |  | days 23-30 of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes type 2, Ramadan, Insulin analogues, Fasting