Effect of Insulin Glargine in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s)
Target Glycemic Control and the Incidence of Symptomatic Nocturnal Hypoglycemia in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s) and Treated With Insulin Glargine or NPH Human Insulin.
1 other identifier
interventional
764
2 countries
2
Brief Summary
The primary objective of this study is to compare the percentage of subjects who reach the target HbA1c level (\< or = 7.0% at endpoint) and do not experience symptomatic nocturnal hypoglycemia during treatment with insulin glargine or NPH human insulin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus-type-2
Started Jan 2000
Typical duration for phase_3 diabetes-mellitus-type-2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2001
CompletedFirst Submitted
Initial submission to the registry
April 1, 2008
CompletedFirst Posted
Study publicly available on registry
April 4, 2008
CompletedApril 20, 2009
April 1, 2009
1.8 years
April 1, 2008
April 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of subjects reaching target HbA1c = or < 7% at endpoint and not experiencing symptomatic nocturnal hypoglycemia
Secondary Outcomes (1)
Safety data (Adverse events, vital signs, laboratory values, etc.)
Interventions
Eligibility Criteria
You may qualify if:
- Insulin naïve subjects with type 2 diabetes treated with oral hypoglycemic agents
- Body mass index between 26 and 40 kg/m2
- HbA1c between 7.5% and 10.0%
- Fasting plasma glucose \>7.8 mmol/L and fasting C-peptide \> or =0.25 nmol/L
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (2)
Sanofi-aventis administrative office
Bridgewater, New Jersey, 08807, United States
Sanofi-aventis administrative office
Laval, Canada
Related Publications (2)
Riddle MC, Rosenstock J, Gerich J; Insulin Glargine 4002 Study Investigators. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care. 2003 Nov;26(11):3080-6. doi: 10.2337/diacare.26.11.3080.
PMID: 14578243RESULTSemlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
PMID: 33166419DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Public Registry ICD
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 1, 2008
First Posted
April 4, 2008
Study Start
January 1, 2000
Primary Completion
October 1, 2001
Study Completion
October 1, 2001
Last Updated
April 20, 2009
Record last verified: 2009-04