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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
INSULIN GLARGINE
INSULIN GLULISINE
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 01201
  • Investigational Site Number 01202
  • Investigational Site Number 01203
  • Investigational Site Number 01204
  • Investigational Site Number 03201
  • Investigational Site Number 03202
  • Investigational Site Number 03203
  • Investigational Site Number 03204
  • Investigational Site Number 03205
  • Investigational Site Number 076-007
  • Investigational Site Number 076-003
  • Investigational Site Number 076-010
  • Investigational Site Number 076-006
  • Investigational Site Number 076-004
  • Investigational Site Number 076-002
  • Investigational Site Number 17003
  • Investigational Site Number 17004
  • Investigational Site Number 17005
  • Investigational Site Number 17007
  • Investigational Site Number 17006
  • Investigational Site Number 01
  • Investigational Site Number 48401
  • Investigational Site Number 48402
  • Investigational Site Number 48404
  • Investigational Site Number 48403
  • Investigational Site Number 1
  • Investigational Site Number 12468
  • Investigational Site Number 710004
  • Investigational Site Number 12466
  • Investigational Site Number 710006
  • Investigational Site Number 12464
  • Investigational Site Number 12465
  • Investigational Site Number 710001
  • Investigational Site Number 710002
  • Investigational Site Number 12484
  • Investigational Site Number 710003
  • Investigational Site Number 12467
  • Investigational Site Number 710005
  • Investigational Site Number 78801
  • Investigational Site Number 78805
  • Investigational Site Number 78803
  • Investigational Site Number 78802
  • Investigational Site Number 78804

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Insulin glargine + insulin glulisine

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change of HbA1c
Percentage of patients with HbA1c < 7%
Fasting Blood Glucose (FBG)
7-point Self Monitoring of Blood Glucose (SMBG)
Daily dose for insulin glulisine
Daily dose for insulin glargine
Symptomatic hypoglycemias

Full Information

First Posted
September 16, 2010
Last Updated
March 14, 2014
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01204593
Brief Title
baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin glargine + insulin glulisine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
INSULIN GLARGINE
Other Intervention Name(s)
Lantus SoloStar
Intervention Description
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day at bedtime
Intervention Type
Drug
Intervention Name(s)
INSULIN GLULISINE
Other Intervention Name(s)
Apidra SoloStar
Intervention Description
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: three times a day, preferably just before the meal
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
Change of HbA1c
Time Frame
from baseline to week 12
Title
Percentage of patients with HbA1c < 7%
Time Frame
at week 12 and week 24
Title
Fasting Blood Glucose (FBG)
Time Frame
at baseline, week 12 and week 24
Title
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)
Title
Daily dose for insulin glulisine
Time Frame
At baseline, week 12 and week 24
Title
Daily dose for insulin glargine
Time Frame
At baseline, week 12 and week 24
Title
Symptomatic hypoglycemias
Time Frame
From baseline (week 0) to endpoint (week 24)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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 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 Exclusion criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 01201
City
Algeries
Country
Algeria
Facility Name
Investigational Site Number 01202
City
Algiers
Country
Algeria
Facility Name
Investigational Site Number 01203
City
Algiers
Country
Algeria
Facility Name
Investigational Site Number 01204
City
Algiers
Country
Algeria
Facility Name
Investigational Site Number 03201
City
Caba
Country
Argentina
Facility Name
Investigational Site Number 03202
City
Caba
Country
Argentina
Facility Name
Investigational Site Number 03203
City
Caba
Country
Argentina
Facility Name
Investigational Site Number 03204
City
Caba
Country
Argentina
Facility Name
Investigational Site Number 03205
City
Morón
Country
Argentina
Facility Name
Investigational Site Number 076-007
City
Curitiba
ZIP/Postal Code
80540-010
Country
Brazil
Facility Name
Investigational Site Number 076-003
City
Distrito Federal
ZIP/Postal Code
71625-009
Country
Brazil
Facility Name
Investigational Site Number 076-010
City
Fortaleza
ZIP/Postal Code
60430-370
Country
Brazil
Facility Name
Investigational Site Number 076-006
City
Marília
ZIP/Postal Code
17519-101
Country
Brazil
Facility Name
Investigational Site Number 076-004
City
Porto Alegre
ZIP/Postal Code
91350-250
Country
Brazil
Facility Name
Investigational Site Number 076-002
City
São Paulo
ZIP/Postal Code
01244-030
Country
Brazil
Facility Name
Investigational Site Number 17003
City
Barranquilla
Country
Colombia
Facility Name
Investigational Site Number 17004
City
Bogotá
Country
Colombia
Facility Name
Investigational Site Number 17005
City
Bogotá
Country
Colombia
Facility Name
Investigational Site Number 17007
City
Bogotá
Country
Colombia
Facility Name
Investigational Site Number 17006
City
Medellin
Country
Colombia
Facility Name
Investigational Site Number 01
City
Kuwait
Country
Kuwait
Facility Name
Investigational Site Number 48401
City
Guadalajara
ZIP/Postal Code
44600
Country
Mexico
Facility Name
Investigational Site Number 48402
City
Guadalajara
ZIP/Postal Code
44656
Country
Mexico
Facility Name
Investigational Site Number 48404
City
Guadalajara
ZIP/Postal Code
44680
Country
Mexico
Facility Name
Investigational Site Number 48403
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Investigational Site Number 1
City
Riyadh
ZIP/Postal Code
11415
Country
Saudi Arabia
Facility Name
Investigational Site Number 12468
City
Benoni
Country
South Africa
Facility Name
Investigational Site Number 710004
City
Benoni
Country
South Africa
Facility Name
Investigational Site Number 12466
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Investigational Site Number 710006
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Investigational Site Number 12464
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Investigational Site Number 12465
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Investigational Site Number 710001
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Investigational Site Number 710002
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Investigational Site Number 12484
City
Port Elizabeth
ZIP/Postal Code
6000
Country
South Africa
Facility Name
Investigational Site Number 710003
City
Port Elizabeth
ZIP/Postal Code
6000
Country
South Africa
Facility Name
Investigational Site Number 12467
City
Pretoria
Country
South Africa
Facility Name
Investigational Site Number 710005
City
Pretoria
Country
South Africa
Facility Name
Investigational Site Number 78801
City
Sfax
Country
Tunisia
Facility Name
Investigational Site Number 78805
City
Sfax
Country
Tunisia
Facility Name
Investigational Site Number 78803
City
Tunis
ZIP/Postal Code
1006
Country
Tunisia
Facility Name
Investigational Site Number 78802
City
Tunis
Country
Tunisia
Facility Name
Investigational Site Number 78804
City
Tunis
Country
Tunisia

12. IPD Sharing Statement

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baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus

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