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

Clalit Health Services

Status and phase: Completed; Phase 4

Conditions: Diabetes Type 2; Treatment During Ramadan

Treatments: Drug: Insulin treatment during Ramadan; Drug: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT01354925

MeirMc062/2011

Details and patient eligibility

About

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.

Enrollment: 245 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

All of these criteria should be present.

1. 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
2. HbA1c in the past three months ≤ 10%
3. Being capable, and willing, to perform self blood glucose monitoring and use a patient diary as required
4. Age > 18 years

Exclusion criteria

Any of the following:

1. Patients with a diagnosis of type 1 diabetes
2. Hypoglycemia unawareness
3. Hypersensitivity to levemir
4. Hypersensitivity to NovoMix70
5. Creatinine > 2.5 mg/l
6. AST and or ALT > 1.5 times the upper limit
7. Pregnancy
8. Mental incapacity, unwillingness or language barrier precluding adequate understanding of the study protocol or cooperation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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245 participants in 2 patient groups

Insulin treatment during Ramadan

Active Comparator group

Description:

Insulin analogs will be used: Levemir and NovoMix70. .

Treatment:

Drug: Insulin treatment during Ramadan

Standard treatment during Ramadan

Active Comparator group

Description:

Standard of care according to physicians choice

Treatment:

Drug: Standard of care