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Insulin Glargine in Type 2 Diabetic Patients

NCT00347100 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 387

Last updated 2009-09-15

No results posted yet for this study

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

Interventions

DRUG

Insulin Glargine

Throughout study period

DRUG

Glyburide

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

DRUG

Glyclazide

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

DRUG

Glimiperide

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

DRUG

Glipizide

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

DRUG

Metformin

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

Sponsors & Collaborators

Principal Investigators

  • Bruno Jolain · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2008-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00347100 on ClinicalTrials.gov