A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar With Type 2 Diabetes Mellitus
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: Insulin glargine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s): Patrick Sinnassamy, MD, Study Director, Affiliation: Sanofi
Summary
Primary objective:
- To determine the optimal treatment algorithm for the clinical use of insulin glargine
based on the incidence of severe hypoglycaemia.
Secondary objectives:
- To determine for each treatment algorithm the incidence of asymptomatic, symptomatic
and nocturnal hypoglycaemia.
- To determine the difference in glycaemic control as measured by HbA1c and fasting blood
glucose between the treatment algorithms.
- To determine the difference in glycaemic control as measured by HbA1c and fasting blood
glucose between baseline and end of treatment.
- To obtain safety data on the use of insulin glargine in each treatment algorithm.
- To measure change in subject weight and insulin dose between baseline and end of
treatment.
- To determine subject quality of life and treatment satisfaction (sub-study)
Clinical Details
Official title: A Multicentre, Multinational, Randomised, Open Study to Establish the Optimal Method for Initiating and Maintaining Lantus® (Insulin Glargine) Therapy Based on a Comparison of Two Treatment Algorithms to Determine Optimal Metabolic Outcomes, Safety, and Satisfaction in Subjects With Type 2 Diabetes Mellitus.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Incidence of severe hypoglycaemia
Secondary outcome: Incidence of any hypoglycaemiaIncidence of symptomatic hypoglycaemia Incidence of nocturnal hypoglycaemia Incidence of asymptomatic hypoglycaemia Adjusted mean change in Hb1Ac (%) Adjusted mean change in fasting blood glucose (FBG) (mg/dl) Adjusted mean change in nocturnal blood glucose (NBG) (mg/dl) Adjusted mean change in mean daily blood glucose (MBG) (mg/dl) % of subjects at v12 with Hb1Ac < or = 6.5 % % of subjects at v12 with Hb1Ac < or = 7.0 % % of subjects at v12 with FBG < or = 100 mg/dl Weight change (kg) Change in insulin glargine dose v2 - v12 (IU) Safety data Quality of Life and treatment satisfaction before, during and at the end of treatment using the Diabetes Treatment Satisfaction Questionnaire
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion criteria:
- Subjects with Type 2 Diabetes Mellitus,
- Subjects on antidiabetic treatment (oral and/or insulin therapy) for > 6 months,
- Subjects who require a basal long-acting insulin for the control of hyperglycaemia,
- HbA1c values > 7. 0% and < 12 %,
- BMI < 40 kg/mĀ².
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
Locations and Contacts
Additional Information
Starting date: March 2002
Last updated: August 30, 2010
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