baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus

Diabetes Mellitus, Type 1 Clinical Trial

— SUBSTITUTE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01204593
• Other study ID #: LANTU_R_05033
• Secondary ID: U1111-1116-3450
• Status: Completed
• Phase: Phase 4
• First received: September 16, 2010
• Last updated: March 14, 2014
• Start date: November 2010
• Est. completion date: January 2013

Study information

• Verified date: March 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical 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).

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• INSULIN GLARGINE
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day at bedtime
• INSULIN GLULISINE
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: three times a day, preferably just before the meal

Locations

Country	Name	City	State
Algeria	Investigational Site Number 01201	Algeries
Algeria	Investigational Site Number 01202	Algiers
Algeria	Investigational Site Number 01203	Algiers
Algeria	Investigational Site Number 01204	Algiers
Argentina	Investigational Site Number 03201	Caba
Argentina	Investigational Site Number 03202	Caba
Argentina	Investigational Site Number 03203	Caba
Argentina	Investigational Site Number 03204	Caba
Argentina	Investigational Site Number 03205	Morón
Brazil	Investigational Site Number 076-007	Curitiba
Brazil	Investigational Site Number 076-003	Distrito Federal
Brazil	Investigational Site Number 076-010	Fortaleza
Brazil	Investigational Site Number 076-006	Marília
Brazil	Investigational Site Number 076-004	Porto Alegre
Brazil	Investigational Site Number 076-002	São Paulo
Colombia	Investigational Site Number 17003	Barranquilla
Colombia	Investigational Site Number 17004	Bogotá
Colombia	Investigational Site Number 17005	Bogotá
Colombia	Investigational Site Number 17007	Bogotá
Colombia	Investigational Site Number 17006	Medellin
Kuwait	Investigational Site Number 01	Kuwait
Mexico	Investigational Site Number 48401	Guadalajara
Mexico	Investigational Site Number 48402	Guadalajara
Mexico	Investigational Site Number 48404	Guadalajara
Mexico	Investigational Site Number 48403	Monterrey
Saudi Arabia	Investigational Site Number 1	Riyadh
South Africa	Investigational Site Number 12468	Benoni
South Africa	Investigational Site Number 710004	Benoni
South Africa	Investigational Site Number 12466	Bloemfontein
South Africa	Investigational Site Number 710006	Bloemfontein
South Africa	Investigational Site Number 12464	Durban
South Africa	Investigational Site Number 12465	Durban
South Africa	Investigational Site Number 710001	Durban
South Africa	Investigational Site Number 710002	Durban
South Africa	Investigational Site Number 12484	Port Elizabeth
South Africa	Investigational Site Number 710003	Port Elizabeth
South Africa	Investigational Site Number 12467	Pretoria
South Africa	Investigational Site Number 710005	Pretoria
Tunisia	Investigational Site Number 78801	Sfax
Tunisia	Investigational Site Number 78805	Sfax
Tunisia	Investigational Site Number 78802	Tunis
Tunisia	Investigational Site Number 78803	Tunis
Tunisia	Investigational Site Number 78804	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin A1c (HbA1c) values (following the reference of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC))		between baseline (week 0) and endpoint (week 24)	No
Secondary	Change of HbA1c		from baseline to week 12	No
Secondary	Percentage of patients with HbA1c < 7%		at week 12 and week 24	No
Secondary	Fasting Blood Glucose (FBG)		at baseline, week 12 and week 24	No
Secondary	7-point Self Monitoring of Blood Glucose (SMBG)		at baseline, week 12 and week 24 (to be performed the week preceding each visit on two consecutive days)	No
Secondary	Daily dose for insulin glulisine		At baseline, week 12 and week 24	No
Secondary	Daily dose for insulin glargine		At baseline, week 12 and week 24	No
Secondary	Symptomatic hypoglycemias		From baseline (week 0) to endpoint (week 24)	Yes