Clinical trial NCT00258804: Insulin Glargine During and After the Period of Fasting in Ramadan
Official title: Evaluation (Safety and Efficacy) of Treatment With Insulin Glargine and Glimepiride in Patients With Type 2 Diabetes Before, During and After the Period of Fasting in Ramadan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-11-28
Enrollment: 450
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 glimepiride (Amaryl®), before, during and after the period of fasting in Ramadan.

Secondary Objectives :

* To assess glycaemic control before, during and after Ramadan in terms of HbA1c, FBG, and 8-point blood glucose profile (FBG and 8-point blood glucose profile will be collected with a blood glucose monitor through a monthly patient diary).
* To assess the relationship between hypoglycaemia events during Ramadan and blood glucose control prior and during Ramadan.
* To assess patient satisfaction
* To document adverse events (all serious adverse events, non serious adverse events) throughout the study (all events will be collected through the monthly patient diary).


Eligibility criteria: 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:

Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Hypoglycaemic events (severe, symptomatic, asymptomatic, nocturnal) before, during and after Ramadan
measure: Glycemic control before, during and after Ramadan in terms of HbA1c, FBG, 8-point blood glucose profile
measure: All other adverse events before, during and after Ramadan
measure: Patient satisfaction before, during and after Ramadan.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Patrick SINNASSAMY, MD
role: STUDY_DIRECTOR
References: