Insulin Glargine During and After the Period of Fasting in Ramadan

NCT00258804 | Completed Phase 4

• 1 other identifier: HOE901_4055
• Study Type: interventional
• Target: 450
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (4)

• 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.

Interventions

Insulin glargine DRUG

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Patrick SINNASSAMY, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 24, 2005
• First Posted: November 28, 2005
• Study Start: May 1, 2005
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: June 8, 2011

Record last verified: 2011-06