Insulin Glargine During and After the Period of Fasting in Ramadan

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Insulin glargine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Patrick SINNASSAMY, MD, Study Director, Affiliation: Sanofi-Aventis

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).

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 design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

Hypoglycaemic events (severe, symptomatic, asymptomatic, nocturnal) before, during and after Ramadan

Glycemic control before, during and after Ramadan in terms of HbA1c, FBG, 8-point blood glucose profile

All other adverse events before, during and after Ramadan

Patient satisfaction before, during and after Ramadan.

Minimum age: 35 Years. Maximum age: N/A. Gender(s): Both.

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

Starting date: May 2005
Last updated: October 13, 2006