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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 | Clinical Trials | Clareo Health

TERMINATEDPHASE4

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

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

NCT00283049•Sanofi

View on ClinicalTrials.gov

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

Age

18 - 79 years

Sex

ALL

Healthy Volunteers

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
+9 more criteria

Locations (1)

sanofi-aventis, US

Bridgewater, New Jersey, United States

Key Dates

Start Date

February 1, 2006

Primary Completion Date

November 1, 2008

Completion Date

November 1, 2008

Last Updated

January 13, 2011

Enrollment

390

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

DRUG

Insulin Glulisine

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

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