Insulin Glargine During and After the Period of Fasting in Ramadan - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00258804

Purpose

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).

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Insulin glargine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin Insulin beef Insulin glargine

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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.

Estimated Enrollment:	450
Study Start Date:	May 2005
Study Completion Date:	February 2006
Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258804

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Patrick SINNASSAMY, MD

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00258804 History of Changes
Other Study ID Numbers:	HOE901_4055
Study First Received:	November 24, 2005
Last Updated:	June 7, 2011
Health Authority:	India: Institutional Review Board

Additional relevant MeSH terms:

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

Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012