Insulin Glargine During and After the Period of Fasting in Ramadan

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00258804
First received: November 24, 2005
Last updated: June 7, 2011
Last verified: June 2011
  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 4

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:


Further study details as provided by Sanofi:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Patrick SINNASSAMY, MD Sanofi
  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 July 29, 2014