Insulin Glargine Injection Treatment in Place of Thiazolidinedione (TZD), Sulfonylurea, or Metformin in Triple Agent Therapy for Type 2 Diabetes Mellitus (T2DM) Adult Subjects With Unsatisfactory Control

NCT ID: NCT00283049

Last Updated: 2011-01-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-11-30

Brief Summary

The purpose of this study is to compare the change in hemoglobin A1c (HbA1c) from baseline to Week 12 between the 3 treatment arms.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulins + Sulfonylurea (SU) + Thiazolidinedione (TZD)

Arm 1: Insulin glargine administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)

Group Type: EXPERIMENTAL

Insulin Glargine

Intervention Type: DRUG

Insulin glargine administered subcutaneously once daily.

Insulin Glulisine

Intervention Type: DRUG

Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)

Insulins + Metformin (MET) + Thiazolidinedione (TZD)

Arm 2: Insulin glargine administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)

Group Type: EXPERIMENTAL

Insulin Glargine

Intervention Type: DRUG

Insulin glargine administered subcutaneously once daily.

Insulin Glulisine

Intervention Type: DRUG

Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)

Insulins + Metformin (MET) + Sulfonylurea (SU)

Arm 3: Insulin glargine administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added arms after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)

Group Type: EXPERIMENTAL

Insulin Glargine

Intervention Type: DRUG

Insulin glargine administered subcutaneously once daily.

Insulin Glulisine

Intervention Type: DRUG

Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)

Interventions

Insulin Glargine

Insulin glargine administered subcutaneously once daily.

Intervention Type: DRUG

Insulin Glulisine

Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Subjects meeting all of the following criteria will be considered for enrollment into the study:

1. 18 to 79 years of age, inclusive

2. Diagnosis of type 2 diabetes mellitus

3. Continuous treatment with therapeutic dosages of a thiazolidinedione (rosiglitazone or pioglitazone), metformin, and a sulfonylurea daily prior to entering the study

4. Screening HbA1c ≥ 7.0%

5. Fasting C-peptide concentration ≥ 0.27 ng/ml

6. Negative glutamic acid decarboxylase (GAD) antibodies

7. Demonstrated ability and willingness to perform self-monitoring blood glucose (SMBG) using a plasma-referenced glucose meter and to maintain an electronic diary

8. Demonstrated ability and willingness to use an electronic diary to record SMBG results, insulin doses, and hypoglycemic events.

9. Signed, informed consent and Health Insurance Portability and Accountability Act (HIPAA) documentation

Exclusion Criteria

1. Stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or angina pectoris, within the last 12 months

2. Cardiac status New York Heart Association (NYHA) III-IV

3. Impaired renal function as shown by, but not limited to, serum creatinine ≥ 1.5 mg/dL for males, or ≥ 1.4 mg/dL for females

4. Chronic use of insulin: (more than 3 weeks of continuous use) in the past 12 months

5. Acute infection

6. Clinically significant peripheral edema

7. Acute or chronic history of metabolic acidosis, including diabetic ketoacidosis

8. Clinical evidence of active liver disease, or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2.5 times the upper limit of the normal range

9. History of hypoglycemia unawareness

10. Pregnancy or lactation

11. Known hypersensitivity to insulin glargine or any of the components of Lantus®

12. Known hypersensitivity to insulin glulisine or any of the components of Apidra®

13. Any malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ

14. Current addiction or current alcohol abuse, or history of substance or alcohol abuse within the last 2 years

15. Diagnosis of dementia

16. Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol

17. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study

18. subject is currently taking or was treated with the following medications 3 months prior to screening: Byetta(exenatide), Starlix(nateglinide),Prandin (repaglinide), Januvia(sitagliptin), Janumet(metformin + sitagliptin)

19. Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Lisa Jean-Louis

Role: STUDY_DIRECTOR

Sanofi

Locations

sanofi-aventis, US

Bridgewater, New Jersey, United States

Countries

United States

Other Identifiers

HOE901_4052

Identifier Type: -

Identifier Source: org_study_id