baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus

NCT01204593 | Completed Phase 4

• 2 other identifiers: LANTU_R_05033U1111-1116-3450
• Study Type: interventional
• Target: 206
• Locations: 9 countries
• Sites: 43

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

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

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

  between baseline (week 0) and endpoint (week 24)

Secondary Outcomes (7)

• Change of HbA1c

  from baseline to week 12

• Percentage of patients with HbA1c < 7%

  at week 12 and week 24

• Fasting Blood Glucose (FBG)

  at baseline, week 12 and week 24

• 7-point Self Monitoring of Blood Glucose (SMBG)

  at baseline, week 12 and week 24 (to be performed the week preceding each visit on two consecutive days)

• Daily dose for insulin glulisine

  At baseline, week 12 and week 24

Study Arms (1)

Insulin glargine + insulin glulisine

EXPERIMENTAL

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; Drug: INSULIN GLULISINE

Interventions

INSULIN GLARGINE DRUG

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

Also known as: Lantus SoloStar

Insulin glargine + insulin glulisine

INSULIN GLULISINE DRUG

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

Also known as: Apidra SoloStar

Insulin glargine + insulin glulisine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (43)

Investigational Site Number 01201

Algeries, Algeria

Location

Investigational Site Number 01202

Algiers, Algeria

Location

Investigational Site Number 01203

Algiers, Algeria

Location

Investigational Site Number 01204

Algiers, Algeria

Location

Investigational Site Number 03201

Caba, Argentina

Location

Investigational Site Number 03202

Caba, Argentina

Location

Investigational Site Number 03203

Caba, Argentina

Location

Investigational Site Number 03204

Caba, Argentina

Location

Investigational Site Number 03205

Morón, Argentina

Location

Investigational Site Number 076-007

Curitiba, 80540-010, Brazil

Location

Investigational Site Number 076-003

Distrito Federal, 71625-009, Brazil

Location

Investigational Site Number 076-010

Fortaleza, 60430-370, Brazil

Location

Investigational Site Number 076-006

Marília, 17519-101, Brazil

Location

Investigational Site Number 076-004

Porto Alegre, 91350-250, Brazil

Location

Investigational Site Number 076-002

São Paulo, 01244-030, Brazil

Location

Investigational Site Number 17003

Barranquilla, Colombia

Location

Investigational Site Number 17004

Bogotá, Colombia

Location

Investigational Site Number 17005

Bogotá, Colombia

Location

Investigational Site Number 17007

Bogotá, Colombia

Location

Investigational Site Number 17006

Medellín, Colombia

Location

Investigational Site Number 01

Kuwait City, Kuwait

Location

Investigational Site Number 48401

Guadalajara, 44600, Mexico

Location

Investigational Site Number 48402

Guadalajara, 44656, Mexico

Location

Investigational Site Number 48404

Guadalajara, 44680, Mexico

Location

Investigational Site Number 48403

Monterrey, 64460, Mexico

Location

Investigational Site Number 1

Riyadh, 11415, Saudi Arabia

Location

Investigational Site Number 12468

Benoni, South Africa

Location

Investigational Site Number 710004

Benoni, South Africa

Location

Investigational Site Number 12466

Bloemfontein, 9301, South Africa

Location

Investigational Site Number 710006

Bloemfontein, 9301, South Africa

Location

Investigational Site Number 12464

Durban, 4091, South Africa

Location

Investigational Site Number 12465

Durban, 4091, South Africa

Location

Investigational Site Number 710001

Durban, 4091, South Africa

Location

Investigational Site Number 710002

Durban, 4091, South Africa

Location

Investigational Site Number 12484

Port Elizabeth, 6000, South Africa

Location

Investigational Site Number 710003

Port Elizabeth, 6000, South Africa

Location

Investigational Site Number 12467

Pretoria, South Africa

Location

Investigational Site Number 710005

Pretoria, South Africa

Location

Investigational Site Number 78801

Sfax, Tunisia

Location

Investigational Site Number 78805

Sfax, Tunisia

Location

Investigational Site Number 78803

Tunis, 1006, Tunisia

Location

Investigational Site Number 78802

Tunis, Tunisia

Location

Investigational Site Number 78804

Tunis, Tunisia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine; insulin glulisine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 17, 2010
• Study Start: November 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 17, 2014

Record last verified: 2014-03

Locations

AL (4); AR (5); SA (1); CO (5); TU (5); BR (6); KU (1); ZA (12); ME (4)