Glycemic Optimization Treatment Study

Overview[ - collapse ][ - ]

Purpose 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 mellitus, with inadequate glycemic control (A1C greater than or equal to 7.0%) on oral antidiabetic drug therapy(OAD).
ConditionDiabetes Mellitus, Type 2
InterventionDrug: Lantus®
PhasePhase 4
SponsorSanofi
Responsible PartySanofi
ClinicalTrials.gov IdentifierNCT00552370
First ReceivedOctober 31, 2007
Last UpdatedJuly 20, 2009
Last verifiedJuly 2009

Tracking Information[ + expand ][ + ]

First Received DateOctober 31, 2007
Last Updated DateJuly 20, 2009
Start DateMarch 2003
Estimated Primary Completion DateMarch 2005
Current Primary Outcome MeasuresTo 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). [Time Frame: From the start to the end of the study] [Designated as safety issue: No]
Current Secondary Outcome MeasuresTo compare the number of subjects whose final A1c is <7.0% at the end of the study for the 5 dosing algorithms. [Time Frame: From the start to the end of the study] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleGlycemic Optimization Treatment Study
Official TitleA Randomized, Open-Label, Parallel-Design Trial. Glycemia Optimization Treatment: Safety of Glucose Control Using Dosing Algorithms With Lantus®(Insulin Glargine [rDNA Origin[) in Adult Individuals With Type 2 Diabetes.
Brief Summary
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 mellitus, with inadequate glycemic
control (A1C greater than or equal to 7.0%) on oral antidiabetic drug therapy(OAD).
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionDiabetes Mellitus, Type 2
InterventionDrug: Lantus®
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment5062
Estimated Completion DateMarch 2005
Estimated Primary Completion DateMarch 2005
Eligibility Criteria
Inclusion Criteria:

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
therapy.

Exclusion Criteria:

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
μmol/L) for males or greater than 1.4 mg/dL (124 μmoL) for females, the inability or
unwillingness to discontinue these medications, and to remain off them through the
entire study.

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 μmol/L).

6. Serum glutamic pyruvic transaminase (SGPT) greater than 2.5 x the upper limit of
normal range.

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.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT00552370
Other Study ID NumbersHOE901_4045
Has Data Monitoring CommitteeNot Provided
Information Provided BySanofi
Study SponsorSanofi
CollaboratorsNot Provided
Investigators Study Director: Karen Barch Sanofi
Verification DateJuly 2009