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

Diabetes Type 2 Clinical Trial

— DMR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354925
• Other study ID #: MeirMc062/2011
• Status: Completed
• Phase: Phase 4
• First received: May 16, 2011
• Last updated: April 11, 2013
• Start date: September 2011
• Est. completion date: October 2011

Study information

• Verified date: April 2013
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2
• Treatment During Ramadan

Intervention

Drug:
• Insulin treatment during Ramadan
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 care
Standard of care during Ramadan according to physicians decision

Locations

Country	Name	City	State
Israel	Clalit HMO	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in mean 4-point SMBG during days 23-30 of treatment between the two groups.		days 23-30 of treatment	No