Type 2 Diabetes Management With Lantus® (Malbec: Manejo C... | NCT00627471

Studies
Type 2 Diabetes Management With Lantus® (Malbec: Manejo Con Lantus® de Diabéticos Tipo 2)

NCT00627471

Sponsor

Sanofi

Status

Terminated

Last Update Posted

Jun 2, 2010Estimated

Enrollment

9Actual

Phase

Phase 4

Conditions

Type 2 Diabetes

Interventions

Insulin Glargine
Insulin Glargine

Countries

Argentina

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low recruitment in spite of strategies implemented

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Not provided

First Submitted Date

Feb 22, 2008

First Submission Date that Met QC Criteria

Feb 29, 2008

First Posted Date

Mar 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2010

Last Update Posted Date

Jun 2, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator	This group must follow a defined algorithm. Only the physicians assigned to this group will know the algorithm.	Drug: Insulin Glargine
B	Active Comparator	This is the control group, following the physician's standard practice.	Drug: Insulin Glargine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Insulin Glargine	Drug	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.

Measure	Description	Time Frame
Mean difference in HbA1c (efficacy)		6 months

Measure	Description	Time Frame
Minor, severe and nocturnal Hypoglycaemic events (safety)		from the begining of the treatment up to 5 days after the end of the study

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones