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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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • 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 ]

Enrollment: 245
Study Start Date: September 2011
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354925

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

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01354925     History of Changes
Other Study ID Numbers: MeirMc062/2011
Study First Received: May 16, 2011
Last Updated: April 11, 2013
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on November 23, 2014