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Insulin Glargine Combination Therapies in Type II Diabetics

NCT00783744 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2009-09-28

No results posted yet for this study

Summary

To compare efficacy of combination therapy of insulin glargine plus glimepiride and metformin versus 2 injections insulin monotherapy with premixed insulin NPH 30/70 bid in terms of change of HbA1c (baseline to endpoint) to show non-inferiority of insulin glargine plus glimepiride and metformin.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin Glargine

In the morning to target FBG ≤ 100 mg/dl

DRUG

Glimepiride

Glimepiride 3 or 4 mg

DRUG

Metformin

At least 850 mg od

DRUG

Insulin monotherapy with premixed insulin NPH 30/70

Given before breakfast and before dinner, target of pre-prandial BG ≤ 100 mg/dl

Sponsors & Collaborators

Principal Investigators

  • Christine Kliebe-Frisch, MD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-12-31
Primary Completion
2003-08-31

Countries

  • Austria
  • Finland
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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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 NCT00783744 on ClinicalTrials.gov