baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus (SUBSTITUTE)

March 14, 2014 updated by: Sanofi

Phase IV, Multicenter, International, Non-comparative, Open Label Study of Efficacy and Safety of Basal Bolus Therapy (Insulin Glargine + Insulin Glulisine) in Patients With T1 Diabetes Previously Uncontrolled on Any Insulin Regimen.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After a two-week run-in period patients will enter a six-month treatment period.

Estimated study duration per patient : 26 weeks (including a 2-week run-in period).

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Algeria
      • Algeries, Algeria
        • Investigational Site Number 01201
      • Algiers, Algeria
        • Investigational Site Number 01202
      • Algiers, Algeria
        • Investigational Site Number 01203
      • Algiers, Algeria
        • Investigational Site Number 01204
  • Argentina
      • Caba, Argentina
        • Investigational Site Number 03201
      • Caba, Argentina
        • Investigational Site Number 03202
      • Caba, Argentina
        • Investigational Site Number 03203
      • Caba, Argentina
        • Investigational Site Number 03204
      • Morón, Argentina
        • Investigational Site Number 03205
  • Brazil
      • Curitiba, Brazil, 80540-010
        • Investigational Site Number 076-007
      • Distrito Federal, Brazil, 71625-009
        • Investigational Site Number 076-003
      • Fortaleza, Brazil, 60430-370
        • Investigational Site Number 076-010
      • Marília, Brazil, 17519-101
        • Investigational Site Number 076-006
      • Porto Alegre, Brazil, 91350-250
        • Investigational Site Number 076-004
      • São Paulo, Brazil, 01244-030
        • Investigational Site Number 076-002
  • Colombia
      • Barranquilla, Colombia
        • Investigational Site Number 17003
      • Bogotá, Colombia
        • Investigational Site Number 17004
      • Bogotá, Colombia
        • Investigational Site Number 17005
      • Bogotá, Colombia
        • Investigational Site Number 17007
      • Medellin, Colombia
        • Investigational Site Number 17006
  • Kuwait
      • Kuwait, Kuwait
        • Investigational Site Number 01
  • Mexico
      • Guadalajara, Mexico, 44600
        • Investigational Site Number 48401
      • Guadalajara, Mexico, 44656
        • Investigational Site Number 48402
      • Guadalajara, Mexico, 44680
        • Investigational Site Number 48404
      • Monterrey, Mexico, 64460
        • Investigational Site Number 48403
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11415
        • Investigational Site Number 1
  • South Africa
      • Benoni, South Africa
        • Investigational Site Number 12468
      • Benoni, South Africa
        • Investigational Site Number 710004
      • Bloemfontein, South Africa, 9301
        • Investigational Site Number 12466
      • Bloemfontein, South Africa, 9301
        • Investigational Site Number 710006
      • Durban, South Africa, 4091
        • Investigational Site Number 710002
      • Durban, South Africa, 4091
        • Investigational Site Number 12464
      • Durban, South Africa, 4091
        • Investigational Site Number 12465
      • Durban, South Africa, 4091
        • Investigational Site Number 710001
      • Port Elizabeth, South Africa, 6000
        • Investigational Site Number 12484
      • Port Elizabeth, South Africa, 6000
        • Investigational Site Number 710003
      • Pretoria, South Africa
        • Investigational Site Number 12467
      • Pretoria, South Africa
        • Investigational Site Number 710005
  • Tunisia
      • Sfax, Tunisia
        • Investigational Site Number 78805
      • Sfax, Tunisia
        • Investigational Site Number 78801
      • Tunis, Tunisia
        • Investigational Site Number 78802
      • Tunis, Tunisia, 1006
        • Investigational Site Number 78803
      • Tunis, Tunisia
        • Investigational Site Number 78804

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Known Type 1 diabetic patients (male or female) treated with any type of insulin regimen, except:

    • continuous subcutaneous insulin infusion (CSII, or pump), and
    • patients already treated with insulin glargine
  2. Age: 18-60 years inclusive
  3. HbA1c: 8% - 10% assessed over the past 6 month
  4. At least 1 year of continuous insulin treatment

  5. Willingness to accept, and ability to follow:

    • a basal bolus regimen (glargine x1 and glulisine x3 per day),
    • self-monitoring blood glucose (SMBG)
    • a fixed meal plan, or CHO counting
  6. Signed informed consent obtained prior to any study procedure

Criteria for entry in the treatment period:

  1. HbA1c 8-10% assessed between week -2 and week 0
  2. Serum creatinine ≤135 micromol/L in men and ≤110 micromol/L in women
  3. Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) lower or equal to three times the upper limit of normal
  4. Pregnancy test negative if women of childbearing potential

Exclusion criteria:

  1. History of hypersensitivity to insulin glargine and/or insulin glulisine
  2. Pregnant, breast-feeding or women of childbearing potential not using efficient contraception
  3. Brittle diabetes
  4. Known impaired renal function defined as serum creatinine > 135 micromol/L in men and > 110 micromol/L in women at study entry
  5. Known impaired hepatic function defined as Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal at study entry
  6. Diabetes ketoacidosis
  7. History of drug or alcohol abuse
  8. Psychiatric or mental disease
  9. Inclusion in another study in the past 6 months or previous inclusion in this study
  10. Patient unable or unwilling to manage properly the basal bolus regimen

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Insulin glargine + insulin glulisine

Insulin glargine dosage will be individually titrated once a week to obtain FPG 80-120 mg/dL (4.5-6.7 mmol/L).

Insulin glulisine dosage will be individually titrated once a week to obtain a 2-hour postprandial plasma glucose (PPG) < 180 mg/dL (<10.0 mmol/L) and ideally around 140 mg/dL.
Drug: INSULIN GLARGINE
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day at bedtime
Other Names:
  • Lantus SoloStar
Drug: INSULIN GLULISINE
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: three times a day, preferably just before the meal
Other Names:
  • Apidra SoloStar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in hemoglobin A1c (HbA1c) values (following the reference of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC))
Time Frame: between baseline (week 0) and endpoint (week 24)
between baseline (week 0) and endpoint (week 24)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of HbA1c
Time Frame: from baseline to week 12
from baseline to week 12
Percentage of patients with HbA1c < 7%
Time Frame: at week 12 and week 24
at week 12 and week 24
Fasting Blood Glucose (FBG)
Time Frame: at baseline, week 12 and week 24
at baseline, week 12 and week 24
7-point Self Monitoring of Blood Glucose (SMBG)
Time Frame: at baseline, week 12 and week 24 (to be performed the week preceding each visit on two consecutive days)
at baseline, week 12 and week 24 (to be performed the week preceding each visit on two consecutive days)
Daily dose for insulin glulisine
Time Frame: At baseline, week 12 and week 24
At baseline, week 12 and week 24
Daily dose for insulin glargine
Time Frame: At baseline, week 12 and week 24
At baseline, week 12 and week 24
Symptomatic hypoglycemias
Time Frame: From baseline (week 0) to endpoint (week 24)
From baseline (week 0) to endpoint (week 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

September 16, 2010

First Submitted That Met QC Criteria

September 16, 2010

First Posted (Estimate)

September 17, 2010

Study Record Updates

Last Update Posted (Estimate)

March 17, 2014

Last Update Submitted That Met QC Criteria

March 14, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LANTU_R_05033
  • U1111-1116-3450 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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