Insulin Glargine During and After the Period of Fasting in Ramadan

NCT ID: NCT00258804

Last Updated: 2011-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2006-02-28

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).

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Insulin glargine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Patrick SINNASSAMY, MD

Role: STUDY_DIRECTOR

Sanofi

Other Identifiers

HOE901_4055

Identifier Type: -

Identifier Source: org_study_id