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
Overview
- Phase
- Phase 4
- Intervention
- Insulin Glargine
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Sanofi
- Enrollment
- 390
- Locations
- 1
- Primary Endpoint
- Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12
- Status
- Terminated
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects meeting all of the following criteria will be considered for enrollment into the study:
- •18 to 79 years of age, inclusive
- •Diagnosis of type 2 diabetes mellitus
- •Continuous treatment with therapeutic dosages of a thiazolidinedione (rosiglitazone or pioglitazone), metformin, and a sulfonylurea daily prior to entering the study
- •Screening HbA1c ≥ 7.0%
- •Fasting C-peptide concentration ≥ 0.27 ng/ml
- •Negative glutamic acid decarboxylase (GAD) antibodies
- •Demonstrated ability and willingness to perform self-monitoring blood glucose (SMBG) using a plasma-referenced glucose meter and to maintain an electronic diary
- •Demonstrated ability and willingness to use an electronic diary to record SMBG results, insulin doses, and hypoglycemic events.
- •Signed, informed consent and Health Insurance Portability and Accountability Act (HIPAA) documentation
Exclusion Criteria
- •Stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or angina pectoris, within the last 12 months
- •Cardiac status New York Heart Association (NYHA) III-IV
- •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
- •Chronic use of insulin: (more than 3 weeks of continuous use) in the past 12 months
- •Acute infection
- •Clinically significant peripheral edema
- •Acute or chronic history of metabolic acidosis, including diabetic ketoacidosis
- •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
- •History of hypoglycemia unawareness
- •Pregnancy or lactation
Arms & Interventions
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%)
Intervention: Insulin Glargine
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%)
Intervention: Insulin Glulisine
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%)
Intervention: Insulin Glargine
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%)
Intervention: Insulin Glulisine
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%)
Intervention: Insulin Glargine
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%)
Intervention: Insulin Glulisine
Outcomes
Primary Outcomes
Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12
Time Frame: 12 weeks from Baseline
Secondary Outcomes
- Percentage of Subjects Achieving an HbA1C Less Than (<) 7.0% and Less Than (<) 6.5%(60 weeks from Baseline)
- 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)(60 weeks from Baseline)
- Change From Baseline to Study Time Points in 7-point Blood Glucose (BG) Profile (Before Meals, 2 Hours After Meals, at Bedtime)(60 weeks from Baseline)
- Change From Baseline to Individual Time Points in HbA1c, Insulin Doses, and Total Insulin Dosage(60 weeks from Baseline)
- Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia(60 weeks from Baseline)
- Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia(60 Weeks from Baseline)