Insulin Glargine in Type 2 Diabetic Patients

NCT00347100 | Completed Phase 4

• 1 other identifier: LANTU_L_01051
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 1

Brief Summary

Primary:

• To investigate the efficacy of insulin glargine (in terms of change in A1c from baseline to endpoint A1c \< 7%) Secondary:
• To investigate the safety of insulin glargine (in terms of hypoglycaemia, including symptomatic, non-symptomatic and nocturnal hypoglycaemia)
• To investigate whether beta cell function is preserved if this therapy is initiated before 2nd OAD (oral anti-diabetic drug) failure

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• A1c values

  At baseline and 24 weeks

Secondary Outcomes (1)

• Adverse events including hypoglycemia

  From the beginning to the end of the study

Study Arms (2)

1

EXPERIMENTAL

Administration of Insulin Glargine and Sulfonylurea or Metformin

Drug: Insulin Glargine; Drug: Metformin

2

ACTIVE COMPARATOR

Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin

Drug: Glyburide; Drug: Glyclazide; Drug: Glimiperide; Drug: Glipizide; Drug: Metformin

Interventions

Insulin Glargine DRUG

Throughout study period

1

Glyburide DRUG

Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.

2

Glyclazide DRUG

Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.

2

Glimiperide DRUG

Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.

2

Glipizide DRUG

Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.

2

Metformin DRUG

Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.

1; 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes patients with first OAD (Sulfonylurea \[SU\] or Metformin) failure
• Patients who are insulin naive (unless it was used for gestational diabetes or if insulin therapy was less than 1 week)
• Serum creatinine ≤ 1.5mg/dL
• BMI: 21-41 kg/m²
• %\< A1c \<11%
• Fasting plasma glucose \> 7.5mmol/L
• On diet and exercise therapy and stable OAD treatment (SU or metformin \> ½ maximal dose)for more than 1 month prior to enrolment
• Women not of childbearing potential (sterilization procedure done or menopausal \> 2 years), or if of childbearing potential, agree to take reliable contraceptive measures during the study
• Able and willing to monitor blood glucose
• Able and willing to perform 7 point blood glucose self monitoring at baseline, 12 week and 24 week
• Understand that there is a 50% chance of being randomized to the insulin treatment arm and is willing to self inject insulin

You may not qualify if:

• Type 1 diabetes
• Acute complication of diabetes, such as diabetic ketoacidosis and hyperosmolar coma
• Pregnancy, breast-feeding
• People who work night shifts
• Hypersensitivity to investigational drugs or its additives, or intolerability to metformin
• Need for use of medications prohibited by the protocol during the study for treatment purpose
• Significant diseases in cardiovascular, liver, nerve, endocrine or other systems, unable to complete the study or difficult to be used in study analysis
• Drugs or alcohol abuse
• 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

Beijing, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; Glyburide; Gliclazide; Glipizide; Metformin

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; Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Benzenesulfonamides; Sulfonamides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Biguanides; Guanidines; Amidines

Study Officials

• Bruno Jolain

  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: June 30, 2006
• First Posted: July 4, 2006
• Study Start: June 1, 2006
• Primary Completion: May 1, 2008
• Last Updated: September 15, 2009

Record last verified: 2009-09

Locations

CN (1)