Insulin Glargine During and After the Period of Fasting in Ramadan

Sanofi

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Insulin glargine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00258804

HOE901_4055

Details and patient eligibility

About

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).

Sex

All

Ages

35+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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