Lantus in Prediabetes | NCT00348972

Studies
Lantus in Prediabetes

NCT00348972

Sponsor

Sanofi

Status

Completed

Last Update Posted

Jul 6, 2006Estimated

Enrollment

Phase

Phase 1

Conditions

Hyperglycemia
Diabetes Mellitus

Interventions

Lantus® (insulin glargine)

Countries

United States

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

ID	Type	Description	Link
HOE901

Status Module

Record Verification Date

Jul 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Feb 2002

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 4, 2006

First Submission Date that Met QC Criteria

Jul 4, 2006

First Posted Date

Jul 6, 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

Jul 4, 2006

Last Update Posted Date

Jul 6, 2006Estimated

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Lantus® (insulin glargine)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy: 8-point blood glucose measurements.
Safety / tolerability: hypoglycemia

Secondary Outcomes

Measure	Description	Time Frame
Blood glucose in response to exercise.
Fasting supine levels of counterregulatory hormones

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hyperglycemia (either IGT , IFG, or untreated type 2 diabetes)
HbA1c < 7.0%
BMI < 40kg/m2
Able to perform moderate stationary bicycle exercise

Exclusion Criteria:

Chronic pharmacologic treatment for hyperglycemia, past or present
CAD
serum creatinine > 2.0mg/dL
BP > 180/105
History of hypoglycemia unawareness

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Peter JOHNSTON, MD	Sanofi	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis		Bridgewater	New Jersey	08807	United States

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D006943	Hyperglycemia
D003920	Diabetes Mellitus
D011236	Prediabetic State
D018149	Glucose Intolerance

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069036	Insulin Glargine

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided