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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01354925
First received: May 16, 2011
Last updated: April 11, 2013
Last verified: April 2013
History of Changes

May 16, 2011
April 11, 2013
September 2011
September 2011   (final data collection date for primary outcome measure)
Difference in mean 4-point SMBG during days 23-30 of treatment between the two groups. [ Time Frame: days 23-30 of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01354925 on ClinicalTrials.gov Archive Site
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Management of Type-2 Diabetic Patients Treated With Insulin During the Ramadan
Management of Type-2 Diabetic Patients Treated With Insulin During the Ramadan An Interventional, Community Based, Comparative Study
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.
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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes Type 2
  • Treatment During Ramadan
  • 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.
  • Drug: Standard of care
    Standard of care during Ramadan according to physicians decision
  • Active Comparator: Insulin treatment during Ramadan
    Insulin analogs will be used: Levemir and NovoMix70. .
    Intervention: Drug: Insulin treatment during Ramadan
  • Active Comparator: Standard treatment during Ramadan
    Standard of care according to physicians choice
    Intervention: Drug: Standard of care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
245
October 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01354925
MeirMc062/2011
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Meir Medical Center
Meir Medical Center
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Principal Investigator: Naim Shehadeh, MD Clalit HMO
Meir Medical Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP