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

Tracking Information
First Submitted Date ICMJE	May 16, 2011
First Posted Date ICMJE	May 17, 2011
Last Update Posted Date	April 12, 2013
Study Start Date ICMJE	September 2011
Actual Primary Completion Date	September 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 16, 2011)	Difference in mean 4-point SMBG during days 23-30 of treatment between the two groups. [ Time Frame: days 23-30 of treatment ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01354925 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Management of Type-2 Diabetic Patients Treated With Insulin During the Ramadan
Official Title ICMJE	Management of Type-2 Diabetic Patients Treated With Insulin During the Ramadan An Interventional, Community Based, Comparative Study
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 Provided
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Diabetes Type 2; Treatment During Ramadan
Intervention ICMJE	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
Study Arms	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
Publications *	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.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: April 8, 2013)	245
Original Estimated Enrollment ICMJE; (submitted: May 16, 2011)	288
Actual Study Completion Date	October 2011
Actual Primary Completion Date	September 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: All of these criteria should be present.; 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; HbA1c in the past three months ≤ 10%; Being capable, and willing, to perform self blood glucose monitoring and use a patient diary as required; Age > 18 years Exclusion Criteria: Any of the following: Patients with a diagnosis of type 1 diabetes; Hypoglycemia unawareness; Hypersensitivity to levemir; Hypersensitivity to NovoMix70; Creatinine > 2.5 mg/l; AST and or ALT > 1.5 times the upper limit; Pregnancy; Mental incapacity, unwillingness or language barrier precluding adequate understanding of the study protocol or cooperation
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Israel
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01354925
Other Study ID Numbers ICMJE	MeirMc062/2011
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Meir Medical Center
Study Sponsor ICMJE	Meir Medical Center
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Naim Shehadeh, MD Clalit HMO
PRS Account	Meir Medical Center
Verification Date	April 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP