Insulin Glargine [rDNA Origin] Injection vs Pioglitazone as add-on Therapy in Patients Failing Monotherapy With Sulfonylurea or Metformin

NCT00384215 | Completed Phase 4

• 1 other identifier: HOE901_4020
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will explore the various advantages and possible disadvantages of pioglitazone and insulin glargine when added to monotherapy. Glycemic control, hypoglycemia, weight, lipid profiles, quality of life and cost will be studied given a comprehensive set of data that may help future treatment decisions.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• To determine whether glycemic control as measured by HbA1c is different between insulin glargine [rDNA Origin] injection and pioglitazone when added to subjects who fail monotherapy with SU or metformin.

Secondary Outcomes (8)

• Compare occurrence of hypoglycemia

• Compare change in body weight

• Compare change in FPG

• Compare change in serum lipid profile

• Compare percentage of subjects achieving HbA1c levels </= 7%

Interventions

insulin glargine [rDNA origin] injection DRUG

Eligibility Criteria

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

You may qualify if:

• Diagnosis of type 2 diabetes mellitus for at least six months
• Continuous treatment with at least 1g metformin or half maximally labeled dose of a SU daily for at least three months
• HbA1c \>/= 8 % and \</= 12%, inclusive, as measured at screening week
• Willingness to accept, and demonstrated ability to inject insulin glargine therapy
• Demonstrated ability and willingness to perform SMBG using a plasma-referenced glucose meter at least twice a day
• Ability to understand and willingness to adhere to and be compliant with the study protocol

You may not qualify if:

• Stroke, myocardial infarction (MI), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months
• Congestive heart failure requiring pharmacological treatment
• Impaired renal function, as shown by but not limited to serum creatinine \>/= 1.5 mg/dl (133µmol/L) for males, or \>/= 1.4 mg/dl (124 µmol/L) for females
• Treatment with non-selective beta-blockers (including ocular)
• Acute infection
• History of or presence of signs of significant peripheral edema
• Acute or chronic or history of metabolic acidosis, including diabetic ketoacidosis
• Planned radiological examinations requiring administration of contrasting agents
• Clinical evidence of active liver disease, or serum ALT 2.5 times the upper limit of the normal range
• History of hypoglycemia unawareness
• Pregnant or breastfeeding females
• Failure to use adequate contraception (women of current reproductive potential only)
• BMI \< 25 kg/(m)(m)
• Treatment with systemic steroids or large doses of inhaled steroids
• Treatment with any diabetes medication other than the medications required by this study

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

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

Study Officials

• Karen Barch, B.S.

  Sanofi

  STUDY DIRECTOR

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: October 4, 2006
• First Posted: October 6, 2006
• Study Start: December 1, 2001
• Study Completion: February 1, 2005
• Last Updated: January 11, 2011

Record last verified: 2011-01

Locations

US (1)