Insulin Glargine During and After the Period of Fasting in Ramadan

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00258804
• Other study ID #: HOE901_4055
• Status: Completed
• Phase: Phase 4
• First received: November 24, 2005
• Last updated: June 7, 2011
• Start date: May 2005
• Est. completion date: February 2006

Study information

• Verified date: June 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin glargine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoglycaemic events (severe, symptomatic, asymptomatic, nocturnal) before, during and after Ramadan
Primary	Glycemic control before, during and after Ramadan in terms of HbA1c, FBG, 8-point blood glucose profile
Primary	All other adverse events before, during and after Ramadan
Primary	Patient satisfaction before, during and after Ramadan.