Type 2 Diabetes Management With Lantus® (Malbec: Manejo Con Lantus® de Diabéticos Tipo 2) - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00627471

Purpose

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

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin glargine

U.S. FDA Resources

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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Mean difference in HbA1c (efficacy) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

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.	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.	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.

Arms

Assigned Interventions

A: Active Comparator

This group must follow a defined algorithm. Only the physicians assigned to this group will know the algorithm.

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.

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.

Eligibility

Ages Eligible for Study:	21 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627471

Contacts

Contact: PUBLIC REGISTRY GMA

publicregistrygma@sanofi-aventis.com

Locations

Argentina
Sanofi-aventis administrative office Argentina	Recruiting
Buenos Aires, Argentina

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Cristian von Schulz-Hausmann

Sanofi-aventis administrative office Argentina

More Information

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

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009