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

NCT00283049 | Terminated Phase 4 Results

• 1 other identifier: HOE901_4052
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12

  12 weeks from Baseline

Secondary Outcomes (6)

• Change From Baseline to Individual Time Points in HbA1c, Insulin Doses, and Total Insulin Dosage

  60 weeks from Baseline

• Percentage of Subjects Achieving an HbA1C Less Than (<) 7.0% and Less Than (<) 6.5%

  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 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

• Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia

  60 weeks from Baseline

Study Arms (3)

Insulins + Sulfonylurea (SU) + Thiazolidinedione (TZD)

EXPERIMENTAL

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%)

Drug: Insulin Glargine; Drug: Insulin Glulisine

Insulins + Metformin (MET) + Thiazolidinedione (TZD)

EXPERIMENTAL

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%)

Drug: Insulin Glargine; Drug: Insulin Glulisine

Insulins + Metformin (MET) + Sulfonylurea (SU)

EXPERIMENTAL

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%)

Drug: Insulin Glargine; Drug: Insulin Glulisine

Interventions

Insulin Glargine DRUG

Insulin glargine administered subcutaneously once daily.

Insulins + Metformin (MET) + Sulfonylurea (SU); Insulins + Metformin (MET) + Thiazolidinedione (TZD); Insulins + Sulfonylurea (SU) + Thiazolidinedione (TZD)

Insulin Glulisine 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); Insulins + Metformin (MET) + Thiazolidinedione (TZD); Insulins + Sulfonylurea (SU) + Thiazolidinedione (TZD)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Known hypersensitivity to insulin glargine or any of the components of Lantus®
• Known hypersensitivity to insulin glulisine or any of the components of Apidra®
• 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
• Current addiction or current alcohol abuse, or history of substance or alcohol abuse within the last 2 years
• Diagnosis of dementia

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

sanofi-aventis, US

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; insulin glulisine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.

Results Point of Contact

• Title: Medical Affairs study director
• Organization: sanofi-aventis

publicregistryUSMA@sanofi-aventis.com

Study Officials

• Lisa Jean-Louis

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 26, 2006
• First Posted: January 27, 2006
• Study Start: February 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: January 13, 2011
• Results First Posted: February 19, 2010

Record last verified: 2011-01

Locations

US (1)