Clinical trial NCT00283049: 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
Official title: Safety and Efficacy of Insulin Glargine Injection [rDNA Origin] Treatment in Place of the TZD or the Sulfonylurea or Metformin in Triple Agent Therapy for T2DM Adult Subjects With Unsatisfactory Control
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-01-27
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12
timeFrame: 12 weeks from Baseline
Secondary outcomes:
measure: Change From Baseline to Individual Time Points in HbA1c, Insulin Doses, and Total Insulin Dosage
timeFrame: 60 weeks from Baseline
measure: Percentage of Subjects Achieving an HbA1C Less Than (<) 7.0% and Less Than (<) 6.5%
timeFrame: 60 weeks from Baseline
measure: Change From Baseline to Study Time Points in 7-point Blood Glucose (BG) Profile (Before Meals, 2 Hours After Meals, at Bedtime)
timeFrame: 60 weeks from Baseline
measure: Change From Baseline to End of Study and to Individual Time Points in Components of Lipid Profile (Total Cholesterol, High-density Lipoprotein Cholesterol [HDL], Low-density Lipoprotein Cholesterol [LDL], Triglycerides, LDL Subfractions)
timeFrame: 60 weeks from Baseline
measure: Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia
timeFrame: 60 weeks from Baseline
measure: Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia
timeFrame: 60 Weeks from Baseline
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: sanofi-aventis, US
state: New Jersey
Study officials:
affiliation: Sanofi
name: Lisa Jean-Louis
role: STUDY_DIRECTOR
References: