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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01354925
Recruitment Status : Completed
First Posted : May 17, 2011
Last Update Posted : April 12, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetes Type 2 Treatment During Ramadan Drug: Insulin treatment during Ramadan Drug: Standard of care Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Management of Type-2 Diabetic Patients Treated With Insulin During the Ramadan An Interventional, Community Based, Comparative Study
Study Start Date : September 2011
Primary Completion Date : September 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Insulin treatment during Ramadan
Insulin analogs will be used: Levemir and NovoMix70. .
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.
Active Comparator: Standard treatment during Ramadan
Standard of care according to physicians choice
Drug: Standard of care
Standard of care during Ramadan according to physicians decision

Outcome Measures

Primary Outcome Measures :
  1. Difference in mean 4-point SMBG during days 23-30 of treatment between the two groups. [ Time Frame: days 23-30 of treatment ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354925

Clalit HMO
Haifa, Israel
Sponsors and Collaborators
Meir Medical Center
Principal Investigator: Naim Shehadeh, MD Clalit HMO
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01354925     History of Changes
Other Study ID Numbers: MeirMc062/2011
First Posted: May 17, 2011    Key Record Dates
Last Update Posted: April 12, 2013
Last Verified: April 2013

Keywords provided by Meir Medical Center:
Diabetes type 2
Insulin analogues

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs