Status:
COMPLETED
Insulin Glargine During and After the Period of Fasting in Ramadan
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
35+ years
Phase:
PHASE4
Brief Summary
Primary Objectives : * To compare the number of hypoglycaemic events (severe, symptomatic, asymptomatic, nocturnal) in patients with type 2 diabetes treated with insulin glargine (Lantus®) and glimep...
Eligibility Criteria
Inclusion
- The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
- Main criteria are listed hereafter:
- Patients with Type 2 Diabetes mellitus (but without history of ketoacidosis);
- BMI \> 25 and \< 40 kg/m2;
- Willingness to participate and to fast during Ramadan;
- Patients should be either:
- Insulin naïve patients
- Patients already receiving insulin
Exclusion
- Pregnancy (as determined by pregnancy blood test at inclusion visit)
- Breast- feeding
- Women of childbearing potential who do not have adequate contraceptive protection
- Need for treatment during the study period with medications that may interfere with the study protocol
- Treatment with any investigational drug (only if in trial) in the last 3 months before entry into the study
- History of drug or alcohol abuse
- Severe and unbalanced diabetic retinopathy
- Clinically relevant cardiovascular, gastrointestinal, hepatic, renal, neurological, endocrine, hematological or other major systemic diseases that may interfere with the study protocol or complicate the interpretation of study results
- Night shift workers
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00258804
Start Date
May 1 2005
End Date
February 1 2006
Last Update
June 8 2011
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