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

Phase 4

Completed

• Conditions: Diabetes Type 2; Treatment During Ramadan
• Interventions: Drug: Standard of care; Drug: Insulin treatment during Ramadan

• Registration Number: NCT01354925
• Lead Sponsor: Meir Medical Center

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-16
• Study First Submitted QC: 2011-05-16
• Study First Posted: 2011-05-17
• Study Start: 2011-09
• Primary Completion: 2011-09
• Study Completion: 2011-10
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-11
• Last Update Posted: 2013-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard treatment during Ramadan	Standard of care	Standard of care according to physicians choice
Insulin treatment during Ramadan	Insulin treatment during Ramadan	Insulin analogs will be used: Levemir and NovoMix70. .

Primary Outcome Measures

Name	Time	Method
Difference in mean 4-point SMBG during days 23-30 of treatment between the two groups.	days 23-30 of treatment

Trial Locations

Locations (1)

Clalit HMO; 🇮🇱 Haifa, Israel