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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00627471 |
To compare in terms of HbA1c insulin naive patients with Type 2 Diabetes starting with insulin glargine on an algorithm with insulin naive patients starting with insulin glargine on the physician's standard practice.
To compare in terms of FBG insulin naïve patients starting with insulin glargine on an algorithm with insulin naïve patients starting with insulin glargine on the physician's standard practice.
To compare the percentage of patients achieving HbA1c< 7% in each treatment group.
To compare hypoglycaemic events (minor, severe and nocturnal) between groups.
To compare average insulin dose between groups.
To compare PRO (patients' reported outcomes) between groups.
To compare mean changes in body weight between treatment groups.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes |
Drug: Insulin Glargine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 24 Weeks, Randomized, 2 Arms, Controlled, Multi-Centre, National, Open-Labeled, Parallel Study in Insulin naïve Patients With Type 2 Diabetes to Compare a Lantus Titration Algorithm vs. Physician's Standard Practice |
Estimated Enrollment: | 200 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
This group must follow a defined algorithm. Only the physicians assigned to this group will know the algorithm.
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Drug: Insulin Glargine
In the group following the algorithm, fasting SMBG will be asked 3 times a week until FBG<100 mg/dl is achieved. Afterwards, 1 fasting SMBG will be asked weekly. Pre-prandial SMBG will be performed at the discretion of the physician. For the group following the algorithm, during the titration period, weekly telephone contacts will be required and a minimum of 4 visits to the clinic. |
B: Active Comparator
This is the control group, following the physician's standard practice.
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Drug: Insulin Glargine
For the control group (following the physician's standard practice) a minimum of 4 visits to the clinic is required. Insulin titration and concomitant medications will be done at the discretion of the physician. Strips will be distributed among patients in this group, but there will not be a requirement in frequency or type of SMBG.
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Ages Eligible for Study: | 21 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Contact: PUBLIC REGISTRY GMA | publicregistrygma@sanofi-aventis.com |
Argentina | |
Sanofi-aventis administrative office Argentina | Recruiting |
Buenos Aires, Argentina |
Study Director: | Cristian von Schulz-Hausmann | Sanofi-aventis administrative office Argentina |
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | LANTU_L_02936 |
Study First Received: | February 22, 2008 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00627471 |
Health Authority: | Argentina: Human Research Bioethics Committee |
Metabolic Diseases Diabetes Mellitus, Type 2 Glargine Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |