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Completed

NCT Number: NCT01204593

baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus

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

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigational Site Number 01201, Algeries, Algeria

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insulin glargine

Drug

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

Other names: Lantus SoloStar

insulin glulisine

Drug

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

Other names: Apidra SoloStar

Primary outcomes

  1. 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 outcomes

  1. Change of HbA1c

    Time frame: from baseline to week 12

  2. Percentage of patients with HbA1c < 7%

    Time frame: at week 12 and week 24

  3. Fasting Blood Glucose (FBG)

    Time frame: at baseline, week 12 and week 24

  4. 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)

  5. Daily dose for insulin glulisine

    Time frame: At baseline, week 12 and week 24

  6. Daily dose for insulin glargine

    Time frame: At baseline, week 12 and week 24

  7. Symptomatic hypoglycemias

    Time frame: From baseline (week 0) to endpoint (week 24)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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.

Acronym: SUBSTITUTE

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 17, 2010
Registry last updated
Mar 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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