Back to resultsLANTUSTITR: Insulin Glargine in Type 2 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Type 2
Status
Terminated
Phase
Phase 4
Locations
Hungary
Study Type
Interventional
Intervention
Insuline glargine
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria: Type 2 Diabetes Mellitus Insufficient combined oral antidiabetic treatment (biguanide + sulfonylurea) BMI >25 kg/m2 , <30 kg/m2 HbA1c value >7.0%, <9.0% within one month Exclusion Criteria: Type 1 Diabetes Mellitus Known malignancy Drug or alcohol abuse Severe liver disease Renal failure (se Creatinine > 150 micro mol/l) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Sanofi-Aventis
Outcomes
Primary Outcome Measures
HgbA1c measurement
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00349986
Brief Title
LANTUSTITR: Insulin Glargine in Type 2 Diabetes Mellitus
Official Title
The Determination of the First Dose and the Optimal Time of Administration of Insulin Glargine Combined With Oral Antidiabetic Drug in Poorly Controlled Type II Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Terminated
Why Stopped
prematurely terminated due to loss of interest
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
The rationale of the study is to determine:
the first dose and the titration of basal insulin
the exact daily time administration of basal insulin in poorly controlled type II diabetic patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Insuline glargine
Primary Outcome Measure Information:
Title
HgbA1c measurement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 Diabetes Mellitus
Insufficient combined oral antidiabetic treatment (biguanide + sulfonylurea)
BMI >25 kg/m2 , <30 kg/m2
HbA1c value >7.0%, <9.0% within one month
Exclusion Criteria:
Type 1 Diabetes Mellitus
Known malignancy
Drug or alcohol abuse
Severe liver disease
Renal failure (se Creatinine > 150 micro mol/l)
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
László Erős, MD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Budapest
Country
Hungary
12. IPD Sharing Statement
Learn more about this trial
LANTUSTITR: Insulin Glargine in Type 2 Diabetes Mellitus
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