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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01204593

First Posted: September 17, 2010

Last Update Posted: March 17, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Sanofi

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 Intervention Model: Single Group Assignment Masking: None (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:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Type 1

Drug Information available for: Insulin Insulin human Insulin glargine Insulin glulisine

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) ]

Secondary Outcome Measures:

Change of HbA1c [ Time Frame: from baseline to week 12 ]
Percentage of patients with HbA1c < 7% [ Time Frame: at week 12 and week 24 ]
Fasting Blood Glucose (FBG) [ Time Frame: at baseline, week 12 and week 24 ]
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) ]
Daily dose for insulin glulisine [ Time Frame: At baseline, week 12 and week 24 ]
Daily dose for insulin glargine [ Time Frame: At baseline, week 12 and week 24 ]
Symptomatic hypoglycemias [ Time Frame: From baseline (week 0) to endpoint (week 24) ]


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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( Other Identifier: WHO )
First Submitted:	September 16, 2010
First Posted:	September 17, 2010
Last Update Posted:	March 17, 2014
Last Verified:	March 2014

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

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