A Trial Comparing Lantus Algorithms to Achieve Normal Blo... | NCT00399724

Studies
A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar With Type 2 Diabetes Mellitus

NCT00399724

Sponsor

Sanofi

Status

Completed

Last Update Posted

Aug 31, 2010Estimated

Enrollment

7,376

Phase

Phase 4

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin glargine

Countries

Not provided

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

Official Title

A Multicentre, Multinational, Randomised, Open Study to Establish the Optimal Method for Initiating and Maintaining Lantus® (Insulin Glargine) Therapy Based on a Comparison of Two Treatment Algorithms to Determine Optimal Metabolic Outcomes, Safety, and Satisfaction in Subjects With Type 2 Diabetes Mellitus.

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2002

Primary Completion Date

Aug 2003Actual

Completion Date

Aug 2003Actual

First Submitted Date

Nov 14, 2006

First Submission Date that Met QC Criteria

Nov 14, 2006

First Posted Date

Nov 15, 2006Estimated

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

Aug 30, 2010

Last Update Posted Date

Aug 31, 2010Estimated

Description Module

Brief Summary

Primary objective:

To determine the optimal treatment algorithm for the clinical use of insulin glargine based on the incidence of severe hypoglycaemia.

Secondary objectives:

To determine for each treatment algorithm the incidence of asymptomatic, symptomatic and nocturnal hypoglycaemia.
To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between the treatment algorithms.
To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between baseline and end of treatment.
To obtain safety data on the use of insulin glargine in each treatment algorithm.
To measure change in subject weight and insulin dose between baseline and end of treatment.
To determine subject quality of life and treatment satisfaction (sub-study)

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

7,376

Name	Type	Description	Arm Group Labels	Other Names
Insulin glargine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of severe hypoglycaemia

Secondary Outcomes

Measure	Description	Time Frame
Incidence of any hypoglycaemia
Incidence of symptomatic hypoglycaemia
Incidence of nocturnal hypoglycaemia

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Subjects with Type 2 Diabetes Mellitus,
Subjects on antidiabetic treatment (oral and/or insulin therapy) for > 6 months,
Subjects who require a basal long-acting insulin for the control of hyperglycaemia,
HbA1c values > 7.0% and < 12 %,
BMI < 40 kg/m².

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

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Patrick Sinnassamy, MD	Sanofi	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18355327	Result	Davies M, Lavalle-Gonzalez F, Storms F, Gomis R; AT.LANTUS Study Group. Initiation of insulin glargine therapy in type 2 diabetes subjects suboptimally controlled on oral antidiabetic agents: results from the AT.LANTUS trial. Diabetes Obes Metab. 2008 May;10(5):387-99. doi: 10.1111/j.1463-1326.2008.00873.x. Epub 2008 Mar 18.
17980928

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