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Diabetes Mellitus, Type 1Phase 4SUBSTITUTENCT01204593

baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus

A Phase 4 study testing INSULIN GLARGINE and INSULIN GLULISINE in people with Diabetes Mellitus, Type 1, run by Sanofi at 43 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
INSULIN GLARGINE and INSULIN GLULISINE
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
206 participants
Where
43 sitesin 9 countries
Study dates
Nov 2010to Jan 2013
Phase
Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
  • Age: 18-60 years inclusive
  • HbA1c: 8% - 10% assessed over the past 6 month
  • At least 1 year of continuous insulin treatment
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  • 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
  • Signed informed consent obtained prior to any study procedure
  • Criteria for entry in the treatment period:
  • HbA1c 8-10% assessed between week -2 and week 0
  • Serum creatinine ≤135 micromol/L in men and ≤110 micromol/L in women
  • Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) lower or equal to three times the upper limit of normal
  • Pregnancy test negative if women of childbearing potential

Who cannot join

  • History of hypersensitivity to insulin glargine and/or insulin glulisine
  • Pregnant, breast-feeding or women of childbearing potential not using efficient contraception
  • Brittle diabetes
  • Known impaired renal function defined as serum creatinine > 135 micromol/L in men and > 110 micromol/L in women at study entry
  • 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
  • Diabetes ketoacidosis
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  • History of drug or alcohol abuse
  • Psychiatric or mental disease
  • Inclusion in another study in the past 6 months or previous inclusion in this study
  • 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.

Trial locations and contacts

43 sites in 9 countries.

43 sites in 9 countries

South Africa12 sites

  • Investigational Site Number 12468

    Benoni

  • Investigational Site Number 710004

    Benoni

  • Investigational Site Number 12466

    Bloemfontein, 9301

  • Investigational Site Number 710006

    Bloemfontein, 9301

  • Investigational Site Number 12464

    Durban, 4091

  • Investigational Site Number 12465

    Durban, 4091

  • Investigational Site Number 710001

    Durban, 4091

  • Investigational Site Number 710002

    Durban, 4091

  • Investigational Site Number 12484

    Port Elizabeth, 6000

  • Investigational Site Number 710003

    Port Elizabeth, 6000

  • Investigational Site Number 12467

    Pretoria

  • Investigational Site Number 710005

    Pretoria

Other trials in South Africa

Brazil6 sites

  • Investigational Site Number 076-007

    Curitiba, 80540-010

  • Investigational Site Number 076-003

    Distrito Federal, 71625-009

  • Investigational Site Number 076-010

    Fortaleza, 60430-370

  • Investigational Site Number 076-006

    Marília, 17519-101

  • Investigational Site Number 076-004

    Porto Alegre, 91350-250

  • Investigational Site Number 076-002

    São Paulo, 01244-030

Other trials in Brazil

Argentina5 sites

  • Investigational Site Number 03201

    Caba

  • Investigational Site Number 03202

    Caba

  • Investigational Site Number 03203

    Caba

  • Investigational Site Number 03204

    Caba

  • Investigational Site Number 03205

    Morón

Other trials in Argentina

Colombia5 sites

  • Investigational Site Number 17003

    Barranquilla

  • Investigational Site Number 17004

    Bogotá

  • Investigational Site Number 17005

    Bogotá

  • Investigational Site Number 17007

    Bogotá

  • Investigational Site Number 17006

    Medellín

Other trials in Colombia

Tunisia5 sites

  • Investigational Site Number 78801

    Sfax

  • Investigational Site Number 78805

    Sfax

  • Investigational Site Number 78803

    Tunis, 1006

  • Investigational Site Number 78802

    Tunis

  • Investigational Site Number 78804

    Tunis

Other trials in Tunisia

Algeria4 sites

  • Investigational Site Number 01201

    Algeries

  • Investigational Site Number 01202

    Algiers

  • Investigational Site Number 01203

    Algiers

  • Investigational Site Number 01204

    Algiers

Other trials in Algeria

Mexico4 sites

  • Investigational Site Number 48401

    Guadalajara, 44600

  • Investigational Site Number 48402

    Guadalajara, 44656

  • Investigational Site Number 48404

    Guadalajara, 44680

  • Investigational Site Number 48403

    Monterrey, 64460

Other trials in Mexico

Kuwait1 site

  • Investigational Site Number 01

    Kuwait City

Other trials in Kuwait

Saudi Arabia1 site

  • Investigational Site Number 1

    Riyadh, 11415

Other trials in Saudi Arabia

About this study

Official title: 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
Read the 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).

Being tested
INSULIN GLARGINE, INSULIN GLULISINE
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INSULIN GLARGINEDrug

    Also called Lantus SoloStar

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

  • INSULIN GLULISINEDrug

    Also called Apidra SoloStar

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

Study groups in NCT01204593
Study groupRoleWhat they receive
Insulin glargine + insulin glulisineExperimentalInsulin 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.
Receives: Drug: INSULIN GLARGINE; Drug: INSULIN GLULISINE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in hemoglobin A1c (HbA1c) values (following the reference of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC))

    Measured: between baseline (week 0) and endpoint (week 24)

Secondary outcomes (7)

  1. Change of HbA1c

    Measured: from baseline to week 12

  2. Percentage of patients with HbA1c < 7%

    Measured: at week 12 and week 24

  3. Fasting Blood Glucose (FBG)

    Measured: at baseline, week 12 and week 24

  4. 7-point Self Monitoring of Blood Glucose (SMBG)

    Measured: at baseline, week 12 and week 24 (to be performed the week preceding each visit on two consecutive days)

  5. Daily dose for insulin glulisine

    Measured: At baseline, week 12 and week 24

  6. Daily dose for insulin glargine

    Measured: At baseline, week 12 and week 24

  7. Symptomatic hypoglycemias

    Measured: From baseline (week 0) to endpoint (week 24)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01204593
Sponsor's protocol ID
LANTU_R_05033
Other IDs
U1111-1116-3450
Acronym
SUBSTITUTE
Status last verified
Mar 2014
First submitted
16 Sep 2010
Last updated
17 Mar 2014
Results posted
No
Data monitoring committee
No

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