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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01204593
First received: September 16, 2010
Last updated: March 14, 2014
Last verified: March 2014
History of Changes
  Purpose

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

Condition Intervention Phase
Diabetes Mellitus, Type 1
 Drug: INSULIN GLARGINE
Drug: INSULIN GLULISINE
 Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of HbA1c [ Time Frame: from baseline to week 12 ] [ Designated as safety issue: No ]
  • Percentage of patients with HbA1c < 7% [ Time Frame: at week 12 and week 24 ] [ Designated as safety issue: No ]
  • Fasting Blood Glucose (FBG) [ Time Frame: at baseline, week 12 and week 24 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Daily dose for insulin glulisine [ Time Frame: At baseline, week 12 and week 24 ] [ Designated as safety issue: No ]
  • Daily dose for insulin glargine [ Time Frame: At baseline, week 12 and week 24 ] [ Designated as safety issue: No ]
  • Symptomatic hypoglycemias [ Time Frame: From baseline (week 0) to endpoint (week 24) ] [ Designated as safety issue: Yes ]
Enrollment: 206
Study Start Date: November 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

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

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
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204593

  Show 43 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01204593     History of Changes
Other Study ID Numbers: LANTU_R_05033  U1111-1116-3450 
Study First Received: September 16, 2010
Last Updated: March 14, 2014
Health Authority: Mexico: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin, Globin Zinc
Insulin glulisine
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016