Assessment of Insulin Glargine in Type 2 Patients for Good Glycemic Control

NCT00701831 | Completed Phase 4

• 1 other identifier: LANTU_L_03502
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective:

• To observe the efficacy of the forced titration to reach good glycemic control in Lantus treated patients Secondary objectives:
• To assess the forced titration on physician and patient satisfaction
• To evaluate the impact of training tools by means of patient profile

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (4)

• HbA1c, FBG

  after treatment end (6 months)

• Final dose

  after treatment end (6 months)

• Number of dose adjustment

  after treatment end (6 months)

• Time to dose titration

  after treatment end (6 months)

Secondary Outcomes (4)

• Hypoglycemia

  after treatment end (6 months)

• Noctural hypoglycemia

  after treatment end (6 months)

• DTSQ

  after treatment end (6 months)

• Physician Satisfaction Questionnaire

  after treatment end (6 months)

Study Arms (1)

1

EXPERIMENTAL

Insulin glargine

Drug: Insulin glargine

Interventions

Insulin glargine DRUG

The dose is titrated according to patient needs

1

Eligibility Criteria

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

You may qualify if:

• T2 insulin naïve patients
• Patients whom their physician is considering initiation of Lantus treatment
• Poor glycemic control 7,5 %10 %
• T2 treatment with OADs more than 3 months
• BMI\<40 kg/m2

You may not qualify if:

• Impaired renal function (Cr\>2mg/dl or current renal dialysis)
• Acute or chronic metabolic acidosis
• Active liver disease or serum ALT or AST \>2,5 than normal
• History of hypoglycemia unawareness
• Diabetic retinopathy with surgery in the previous 3 months or planned within 3 months after study entry
• Pregnancy, breast feeding
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Istanbul, Turkey (Türkiye)

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

• Zeynep Cetin

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 18, 2008
• First Posted: June 19, 2008
• Study Start: May 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 4, 2010

Record last verified: 2010-11

Locations

TU (1)