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baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus

NCT01204593 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2014-03-17

No results posted yet for this study

Summary

Primary Objective:

To evaluate the efficacy of the association Lantus (once-a-day, od) Apidra (thrice-a-day, tid) in terms of change HbA1c from baseline to end of study (week 24), in patients with Type 1 Diabetes Mellitus (T1DM).

Secondary Objectives:

To evaluate:

* The change of hemoglobin A1c (HbA1c) from baseline to week 12
* The percentage of patients with HbA1c \< 7% at week 12 and week 24
* The FBG and the 7-point self monitoring of blood glucose (SMBG) at baseline, week 12 and week 24
* The daily dose for both insulin glulisine insulin glargine at baseline, week 12 and week 24
* The incidence of symptomatic hypoglycemias
* Adverse events

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

INSULIN GLARGINE

Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day at bedtime

DRUG

INSULIN GLULISINE

Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: three times a day, preferably just before the meal

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Algeria
  • Argentina
  • Brazil
  • Colombia
  • Kuwait
  • Mexico
  • Saudi Arabia
  • South Africa
  • Tunisia

Study Locations

More Related Trials

Entities

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 NCT01204593 on ClinicalTrials.gov