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Intensive Insulin Glulisine Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs

NCT01203111 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2012-08-30

No results posted yet for this study

Summary

Primary Objective:

To evaluate the efficacy of an intensive insulin regimen with insulin glargine and insulin glulisine in terms of change in Hemoglobin A1c (HbA1c) level from week 12 (visit 7) to week 24 (visit 10).

Secondary Objectives:

1. Percentage of patients with HbA1c \< 7% at week 24.
2. Percentage of patients with HbA1c \< 7% and no symptomatic nocturnal hypoglycemia event at week 24.
3. Fasting Plasma Glucose (FPG) and 7-point Self Monitoring of Blood Glucose (SMBG) at week 0, week 12 and week 24.
4. Doses of insulin glargine and insulin glulisine: the daily dose (U) and the daily dose / kg (U/kg) will be calculated at week 24.
5. Systolic and diastolic blood pressure, heart rate, weight change will be measured at week 0, week 12 and week 24.
6. Number of patients suffering hypoglycemias (asymptomatic, symptomatic, nocturnal symptomatic, severe and nocturnal severe) will be evaluated during the treatment period. 7-Adverse events.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

INSULIN GLARGINE

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

DRUG

INSULIN GLULISINE

Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day, 0 to 15 minutes before the main meal

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Algeria
  • Brazil
  • Israel
  • Lebanon
  • Mexico
  • Morocco
  • Peru
  • Saudi Arabia
  • United Arab Emirates
  • Venezuela

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 NCT01203111 on ClinicalTrials.gov