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

NCT ID: NCT01354925

Last Updated: 2013-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 245 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2011-10-31

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.

Conditions

Diabetes Type 2; Treatment During Ramadan

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin treatment during Ramadan

Insulin analogs will be used: Levemir and NovoMix70. .

Group Type: ACTIVE_COMPARATOR

Insulin treatment during Ramadan

Intervention Type: DRUG

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 treatment during Ramadan

Standard of care according to physicians choice

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: DRUG

Standard of care during Ramadan according to physicians decision

Interventions

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.

Intervention Type: DRUG

Standard of care

Standard of care during Ramadan according to physicians decision

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naim Shehadeh, MD

Role: PRINCIPAL_INVESTIGATOR

Clalit HMO

Locations

Clalit HMO

Haifa, , Israel

Countries

Israel

References

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.

Reference Type: DERIVED

PMID: 26234442 (View on PubMed)

Other Identifiers

MeirMc062/2011

Identifier Type: -

Identifier Source: org_study_id