Glycemic Optimization Treatment Study

NCT00552370 | Completed Phase 4

• 1 other identifier: HOE901_4045
• Study Type: interventional
• Target: 5,062
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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).

  From the start to the end of the study

Secondary Outcomes (1)

• To compare the number of subjects whose final A1c is <7.0% at the end of the study for the 5 dosing algorithms.

  From the start to the end of the study

Interventions

Lantus® DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must give their signed informed consent.
• Diagnosis of Type 2 DM for at least 6 months.
• Males and females greater than or equal to 18 years of age.
• A1c greater than or equal to 7.0%.
• Current (last 2 months) diabetes therapy with oral anti-hyperglycemia agents only.
• Demonstrated willingness and ability to inject insulin glargine.
• Able to understand and willing to comply with procedures required by the protocol and have access to a phone.
• Demonstrated ability and willingness to perform self-monitoring of blood glucose (SMBG) and use of the algorithm calculator (AL-CAL).
• BMI greater than 25.0 kg/m2.
• Subjects who, in the opinion of the investigator, should be initiated on insulin therapy.

You may not qualify if:

• Cardiac status New York Heart Association (NYHA) III-IV (Appendix A).
• 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.
• For subjects on thiazolidinediones, the inability or unwillingness to discontinue these medications and to remain off them through the entire study.
• Planned pregnancy, pregnancy, or lactation.
• Serum creatinine greater than 3.0 mg/dL (266 μmol/L).
• Serum glutamic pyruvic transaminase (SGPT) greater than 2.5 x the upper limit of normal range.
• Any current malignancy or cancer within the past 5 years (except adequately treated basal cell carcinoma or cervical carcinoma in situ).
• Diagnosis of dementia or mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
• Hypersensitivity to Lantus® insulin or any of its components.
• 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.
• Current (last 2 months) insulin therapy.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Karen Barch

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 31, 2007
• First Posted: November 1, 2007
• Study Start: March 1, 2003
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: July 21, 2009

Record last verified: 2009-07