TARGET: Insulin Glargine in Type 2 Diabetic Patients
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: Insulin Glargine (Drug); Glyburide, Glyclazide,Glimiperide,Glipizide, Metformin (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Bruno Jolain, Study Director, Affiliation: Sanofi-Aventis
Summary
Primary:
- To investigate the efficacy of insulin glargine (in terms of change in A1c from baseline
to endpoint A1c < 7%)
Secondary:
- To investigate the safety of insulin glargine (in terms of hypoglycaemia, including
symptomatic, non-symptomatic and nocturnal hypoglycaemia)
- To investigate whether beta cell function is preserved if this therapy is initiated
before 2nd OAD (oral anti-diabetic drug) failure
Clinical Details
Official title: Treatment of Early Insulinization With Glargine in Type 2 Diabetes Patients Uncontrolled on Sulfonylurea or Metformin Monotherapy
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: A1c values
Secondary outcome: Adverse events including hypoglycemia
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Type 2 diabetes patients with 1st OAD (Sulfonylurea [SU] or Metformin) failure
- Patients who are insulin naive (unless it was used for gestational diabetes or if
insulin therapy was less than 1 week)
- Serum creatinine
- BMI: 21-41 kg/m2
- 7. 5%< A1c <11%
- Fasting plasma glucose > 7. 5mmol/L
- On diet and exercise therapy and stable OAD treatment (SU or metformin > ½ maximal
dose)for more than 1 month prior to enrolment
- Women not of childbearing potential (sterilization procedure done or menopausal > 2
years), or if of childbearing potential, agree to take reliable contraceptive measures
during the study
- Able and willing to monitor blood glucose
- Able and willing to perform 7 point blood glucose self monitoring at baseline, 12 week
and 24 week
- Understand that there is a 50% chance of being randomized to the insulin treatment arm
and is willing to self inject insulin
Exclusion Criteria:
- Type 1 diabetes
- Acute complication of diabetes, such as diabetic ketoacidosis and hyperosmolar coma
- Pregnancy, breast-feeding
- People who work night shifts
- Hypersensitivity to investigational drugs or its additives, or intolerability to
metformin
- Need for use of medications prohibited by the protocol during the study for treatment
purpose
- Significant diseases in cardiovascular, liver, nerve, endocrine or other systems,
unable to complete the study or difficult to be used in study analysis
- Drugs or alcohol abuse
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
Locations and Contacts
Sanofi-Aventis, Beijing, China
Additional Information
Starting date: June 2006
Last updated: March 12, 2008
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