Type 2 Diabetes Management With Lantus® (Malbec: Manejo Con Lantus® de Diabéticos Tipo 2) (Malbec)
Primary Purpose
Type 2 Diabetes
Status
Terminated
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
Insulin Glargine
Insulin Glargine
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria:
- Patients with type 2 diabetes.
- Patients in treatment with OADs (one or more) for at least 1 year who failed metabolic control (HbA1c > 8% and < 11%).
- FBG > 130 mg/dl and < 240 mg/dl.
- BMI < 40 kg/m2 and >25 kg/m2.
- Ability and willingness to follow a tight anti-diabetic therapy and to perform SMBG controls.
Exclusion Criteria:
- C peptide < 0.30 nmol/l.
- Unexplained weight loss of more than 10% of body weight in the last 6 months.
- Pregnant women or women with the intention of becoming pregnant.
- Women with childbearing potential who will not use contraceptive protection.
- Breastfeeding women.
- Patients using or that have used rapid or ultra-rapid acting insulins; except for those patients that have used rapid or ultra-rapid insulins during intercurrences such as AMI, severe infection or surgery.
- Renal impairment defined as serum creatinine >1.4 mg/dl in women and >1.5 mg/dl in men.
- Hepatic impairment defined as GPT or GOT above 2x the normal threshold.
- Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (non selective beta blockers and systemic corticosteroids).
- History of drug or alcoholic abuse.
- Diabetic retinopathy with surgical treatment in the 3 months prior to study entry or which may require surgical treatment within 6 months of study entry.
- Clinically relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, hematological, oncologic or other major systemic disease making implementation of the protocol or interpretation of the study results difficult, at the discretion of the investigator.
- Evidence of an uncooperative attitude, including poor compliance to any anti- diabetic treatment.
- Known hypersensitivity to insulin glargine.
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 administrative office Argentina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A
B
Arm Description
This group must follow a defined algorithm. Only the physicians assigned to this group will know the algorithm.
This is the control group, following the physician's standard practice.
Outcomes
Primary Outcome Measures
Mean difference in HbA1c (efficacy)
Secondary Outcome Measures
Minor, severe and nocturnal Hypoglycaemic events (safety)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00627471
Brief Title
Type 2 Diabetes Management With Lantus® (Malbec: Manejo Con Lantus® de Diabéticos Tipo 2)
Acronym
Malbec
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment in spite of strategies implemented
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
This group must follow a defined algorithm. Only the physicians assigned to this group will know the algorithm.
Arm Title
B
Arm Type
Active Comparator
Arm Description
This is the control group, following the physician's standard practice.
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean difference in HbA1c (efficacy)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Minor, severe and nocturnal Hypoglycaemic events (safety)
Time Frame
from the begining of the treatment up to 5 days after the end of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with type 2 diabetes.
Patients in treatment with OADs (one or more) for at least 1 year who failed metabolic control (HbA1c > 8% and < 11%).
FBG > 130 mg/dl and < 240 mg/dl.
BMI < 40 kg/m2 and >25 kg/m2.
Ability and willingness to follow a tight anti-diabetic therapy and to perform SMBG controls.
Exclusion Criteria:
C peptide < 0.30 nmol/l.
Unexplained weight loss of more than 10% of body weight in the last 6 months.
Pregnant women or women with the intention of becoming pregnant.
Women with childbearing potential who will not use contraceptive protection.
Breastfeeding women.
Patients using or that have used rapid or ultra-rapid acting insulins; except for those patients that have used rapid or ultra-rapid insulins during intercurrences such as AMI, severe infection or surgery.
Renal impairment defined as serum creatinine >1.4 mg/dl in women and >1.5 mg/dl in men.
Hepatic impairment defined as GPT or GOT above 2x the normal threshold.
Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (non selective beta blockers and systemic corticosteroids).
History of drug or alcoholic abuse.
Diabetic retinopathy with surgical treatment in the 3 months prior to study entry or which may require surgical treatment within 6 months of study entry.
Clinically relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, hematological, oncologic or other major systemic disease making implementation of the protocol or interpretation of the study results difficult, at the discretion of the investigator.
Evidence of an uncooperative attitude, including poor compliance to any anti- diabetic treatment.
Known hypersensitivity to insulin glargine.
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
Cristian von Schulz-Hausmann
Organizational Affiliation
Sanofi-aventis administrative office Argentina
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-aventis administrative office Argentina
City
Buenos Aires
Country
Argentina
12. IPD Sharing Statement
Learn more about this trial
Type 2 Diabetes Management With Lantus® (Malbec: Manejo Con Lantus® de Diabéticos Tipo 2)
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