Glycemic Optimization Treatment Study
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: Lantus┬« (Drug)
Phase: Phase 4
Sponsored by: Sanofi-Aventis
Official(s) and/or principal investigator(s):
Karen Barch, Study Director, Affiliation: Sanofi-Aventis
To compare the frequency of severe hypoglycemia events for 5 dosing algorithms of Lantus«,
each of varying intensity and defined by their end-of - study target for self monitored plasma
glucose(SMPG), in patients with Type 2 diabetes mellitis, with inadequate glycemic control
(A1C greater than or equal to 7. 0%) on oral antidiabetic drug therapy(OAD).
Official title: Glycemia Optimization Treatment: Safety of Glucose Control Using Dosing Algorithms With Lantus«(Insulin Glargine [rDNA Origin[) in Adult Individuals With Type 2 Diabetes.
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To compare the frequency of severe hypoglycemia events for 5 dosing algorithms of Lantus«, each of varying intensity and defined by their end-of-study target for self monitored blood glucose (SMBG).
Secondary outcome: To compare the number of subjects whose final A1c is <7.0% at the end of the study for the 5 dosing algorithms.
Minimum age: 18 Years.
Maximum age: N/A.
1. Subjects must give their signed informed consent.
2. Diagnosis of Type 2 DM for at least 6 months.
3. Males and females greater than or equal to 18 years of age.
4. A1c greater than or equal to 7. 0%.
5. Current (last 2 months) diabetes therapy with oral anti-hyperglycemia agents only.
6. Demonstrated willingness and ability to inject insulin glargine.
7. Able to understand and willing to comply with procedures required by the protocol and
have access to a phone.
8. Demonstrated ability and willingness to perform self-monitoring of blood glucose
(SMBG) and use of the algorithm calculator (AL-CAL).
9. BMI greater than 25. 0 kg/m2.
10. Subjects who, in the opinion of the investigator, should be initiated on insulin
1. Cardiac status New York Heart Association (NYHA) III-IV (Appendix A).
2. For subjects treated with metformin (Glucophager, Glucophage XRr, Glucovancer,
Metaglipr , or Avandametr) plus a serum creatinine greater than 1. 5 mg/dL (133 ╬╝mol/L)
for males or greater than 1. 4 mg/dL (124 ╬╝moL) for females, the inability or
unwillingness to discontinue these medications, and to remain off them through the
3. For subjects on thiazolidinediones, the inability or unwillingness to discontinue
these medications and to remain off them through the entire study.
4. Planned pregnancy, pregnancy, or lactation.
5. Serum creatinine greater than 3. 0 mg/dL (266 ╬╝mol/L).
6. Serum glutamic pyruvic transaminase (SGPT) greater than 2. 5 x the upper limit of
7. Any current malignancy or cancer within the past 5 years (except adequately treated
basal cell carcinoma or cervical carcinoma in situ).
8. Diagnosis of dementia or mental condition rendering the subject unable to understand
the nature, scope, and possible consequences of the study.
9. Hypersensitivity to Lantus┬« insulin or any of its components.
10. Any disease or condition, including the abuse of illicit drugs, prescription
medicines, or alcohol that, in opinion of the sponsor/investigator, may interfere with
the completion of the study.
11. Current (last 2 months) insulin therapy.
12. With the exception of thiazolidinediones (for all potential subjects) and for subjects
who are taking metformin and have an exclusionary creatinine level, the ability or
unwillingness to continue pre-study anti-hyperglycemia agents at pre-study dosages
through the entire study.
Locations and Contacts
Starting date: March 2003
Ending date: February 2005
Last updated: April 22, 2008