Clinical trial NCT01204593: baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-09-17
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in hemoglobin A1c (HbA1c) values (following the reference of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC))
timeFrame: between baseline (week 0) and endpoint (week 24)
Secondary outcomes:
measure: Change of HbA1c
timeFrame: from baseline to week 12
measure: Percentage of patients with HbA1c < 7%
timeFrame: at week 12 and week 24
measure: Fasting Blood Glucose (FBG)
timeFrame: at baseline, week 12 and week 24
measure: 7-point Self Monitoring of Blood Glucose (SMBG)
timeFrame: at baseline, week 12 and week 24 (to be performed the week preceding each visit on two consecutive days)
measure: Daily dose for insulin glulisine
timeFrame: At baseline, week 12 and week 24
measure: Daily dose for insulin glargine
timeFrame: At baseline, week 12 and week 24
measure: Symptomatic hypoglycemias
timeFrame: From baseline (week 0) to endpoint (week 24)
Other outcomes:
Locations:
city: Algeries
country: Algeria
facility: Investigational Site Number 01201
city: Algiers
country: Algeria
facility: Investigational Site Number 01202
city: Algiers
country: Algeria
facility: Investigational Site Number 01203
city: Algiers
country: Algeria
facility: Investigational Site Number 01204
city: Caba
country: Argentina
facility: Investigational Site Number 03201
city: Caba
country: Argentina
facility: Investigational Site Number 03202
city: Caba
country: Argentina
facility: Investigational Site Number 03203
city: Caba
country: Argentina
facility: Investigational Site Number 03204
city: Morón
country: Argentina
facility: Investigational Site Number 03205
city: Curitiba
country: Brazil
facility: Investigational Site Number 076-007
city: Distrito Federal
country: Brazil
facility: Investigational Site Number 076-003
city: Fortaleza
country: Brazil
facility: Investigational Site Number 076-010
city: Marília
country: Brazil
facility: Investigational Site Number 076-006
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 076-004
city: São Paulo
country: Brazil
facility: Investigational Site Number 076-002
city: Barranquilla
country: Colombia
facility: Investigational Site Number 17003
city: Bogotá
country: Colombia
facility: Investigational Site Number 17004
city: Bogotá
country: Colombia
facility: Investigational Site Number 17005
city: Bogotá
country: Colombia
facility: Investigational Site Number 17007
city: Medellin
country: Colombia
facility: Investigational Site Number 17006
city: Kuwait
country: Kuwait
facility: Investigational Site Number 01
city: Guadalajara
country: Mexico
facility: Investigational Site Number 48401
city: Guadalajara
country: Mexico
facility: Investigational Site Number 48402
city: Guadalajara
country: Mexico
facility: Investigational Site Number 48404
city: Monterrey
country: Mexico
facility: Investigational Site Number 48403
city: Riyadh
country: Saudi Arabia
facility: Investigational Site Number 1
city: Benoni
country: South Africa
facility: Investigational Site Number 12468
city: Benoni
country: South Africa
facility: Investigational Site Number 710004
city: Bloemfontein
country: South Africa
facility: Investigational Site Number 12466
city: Bloemfontein
country: South Africa
facility: Investigational Site Number 710006
city: Durban
country: South Africa
facility: Investigational Site Number 12464
city: Durban
country: South Africa
facility: Investigational Site Number 12465
city: Durban
country: South Africa
facility: Investigational Site Number 710001
city: Durban
country: South Africa
facility: Investigational Site Number 710002
city: Port Elizabeth
country: South Africa
facility: Investigational Site Number 12484
city: Port Elizabeth
country: South Africa
facility: Investigational Site Number 710003
city: Pretoria
country: South Africa
facility: Investigational Site Number 12467
city: Pretoria
country: South Africa
facility: Investigational Site Number 710005
city: Sfax
country: Tunisia
facility: Investigational Site Number 78801
city: Sfax
country: Tunisia
facility: Investigational Site Number 78805
city: Tunis
country: Tunisia
facility: Investigational Site Number 78803
city: Tunis
country: Tunisia
facility: Investigational Site Number 78802
city: Tunis
country: Tunisia
facility: Investigational Site Number 78804
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: