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Insulin Glargine During and After the Period of Fasting in Ramadan

NCT00258804 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2011-06-08

No results posted yet for this study

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

Interventions

DRUG

Insulin glargine

Sponsors & Collaborators

Principal Investigators

  • Patrick SINNASSAMY, MD · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2006-02-28
Completion
2006-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00258804 on ClinicalTrials.gov