Insulin Glargine in Type 2 Diabetic Patients

Diabetes Mellitus, Type 2 Clinical Trial

— TARGET  

Official title:

Treatment of Early Insulinization With Glargine in Type 2 Diabetes Patients Uncontrolled on Sulfonylurea or Metformin Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00347100
• Other study ID #: LANTU_L_01051
• Status: Completed
• Phase: Phase 4
• First received: June 30, 2006
• Last updated: September 14, 2009
• Start date: June 2006

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 387
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes patients with first 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 = 1.5mg/dL

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin Glargine
Throughout study period
• Glyburide
Combination throughout the study period. Titrate to FPG = 100 mg/dl.
• Glyclazide
Combination throughout the study period. Titrate to FPG = 100 mg/dl.
• Glimiperide
Combination throughout the study period. Titrate to FPG = 100 mg/dl.
• Glipizide
Combination throughout the study period. Titrate to FPG = 100 mg/dl.
• Metformin
Combination throughout the study period. Titrate to FPG = 100 mg/dl.

Locations

Country	Name	City	State
China	Sanofi-Aventis	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A1c values		At baseline and 24 weeks	No
Secondary	Adverse events including hypoglycemia		From the beginning to the end of the study	Yes