Insulin Glargine During and After the Period of Fasting in Ramadan

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin glargine

Drug

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Nov 28, 2005
Registry last updated: Jun 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed