baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus

NCT ID: NCT01204593

Last Updated: 2014-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-01-31

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).

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

INSULIN GLARGINE

Intervention Type: DRUG

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

INSULIN GLULISINE

Intervention Type: DRUG

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

Interventions

INSULIN GLARGINE

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

Intervention Type: DRUG

INSULIN GLULISINE

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

Intervention Type: DRUG

Other Intervention Names

Lantus SoloStar; Apidra SoloStar

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 01201

Algeries, , Algeria

Investigational Site Number 01202

Algiers, , Algeria

Investigational Site Number 01203

Algiers, , Algeria

Investigational Site Number 01204

Algiers, , Algeria

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, , Argentina

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, , Brazil

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

Medellín, , Colombia

Investigational Site Number 01

Kuwait City, , Kuwait

Investigational Site Number 48401

Guadalajara, , Mexico

Investigational Site Number 48402

Guadalajara, , Mexico

Investigational Site Number 48404

Guadalajara, , Mexico

Investigational Site Number 48403

Monterrey, , Mexico

Investigational Site Number 1

Riyadh, , Saudi Arabia

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, , South Africa

Investigational Site Number 78801

Sfax, , Tunisia

Investigational Site Number 78805

Sfax, , Tunisia

Investigational Site Number 78803

Tunis, , Tunisia

Investigational Site Number 78802

Tunis, , Tunisia

Investigational Site Number 78804

Tunis, , Tunisia

Countries

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

Other Identifiers

U1111-1116-3450

Identifier Type: OTHER

Identifier Source: secondary_id

LANTU_R_05033

Identifier Type: -

Identifier Source: org_study_id