Intensive Insulin Glulisine Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs

NCT01203111 | Completed Phase 4

• 2 other identifiers: LANTU_R_05048U1111-1116-3517
• Study Type: interventional
• Target: 207
• Locations: 10 countries
• Sites: 10

Brief Summary

Primary Objective: To evaluate the efficacy of an intensive insulin regimen with insulin glargine and insulin glulisine in terms of change in Hemoglobin A1c (HbA1c) level from week 12 (visit 7) to week 24 (visit 10). Secondary Objectives:

1. 1.Percentage of patients with HbA1c \< 7% at week 24.
2. 2.Percentage of patients with HbA1c \< 7% and no symptomatic nocturnal hypoglycemia event at week 24.
3. 3.Fasting Plasma Glucose (FPG) and 7-point Self Monitoring of Blood Glucose (SMBG) at week 0, week 12 and week 24.
4. 4.Doses of insulin glargine and insulin glulisine: the daily dose (U) and the daily dose / kg (U/kg) will be calculated at week 24.
5. 5.Systolic and diastolic blood pressure, heart rate, weight change will be measured at week 0, week 12 and week 24.
6. 6.Number of patients suffering hypoglycemias (asymptomatic, symptomatic, nocturnal symptomatic, severe and nocturnal severe) will be evaluated during the treatment period. 7-Adverse events.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c level for patients with addition of glulisine at week 12

  between week 12 and week 24 (end of treatment period)

Secondary Outcomes (8)

• Percentage of patients with HbA1c level < 7%

  at week 24 (end of treatment period)

• Percentage of patients with HbA1c level < 7% and no symptomatic nocturnal hypoglycemia event

  at week 24 (end of treatment period)

• Fasting Plasma Glucose

  at week 0, week 12 and week 24

• 7-point Self Monitoring of Blood Glucose

  at week 0, week 12 and week 24

• Daily dose of insulin glargine

  at week 24 (end of treatment period)

Study Arms (2)

Intensive insulin regimen

EXPERIMENTAL

Treatment Period 1: Insulin glargine + metformin + other OGLDs, if any Treatment period 2: + insulin glulisine if HbA1c ≥7% at week 12 (end of treatment period 1)

Drug: INSULIN GLARGINE; Drug: INSULIN GLULISINE

insulin regimen

EXPERIMENTAL

Treatment Period 1: Insulin glargine + metformin + other OGLDs, if any Treatment period 2: no change, if HbA1c \<7% at week 12 (end of treatment period 1)

Drug: INSULIN GLARGINE

Interventions

INSULIN GLARGINE DRUG

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

Also known as: Lantus SoloStar

Intensive insulin regimen; insulin regimen

INSULIN GLULISINE DRUG

Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day, 0 to 15 minutes before the main meal

Also known as: Apidra SoloStar

Intensive insulin regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• in the run-in period:
• Uncontrolled Type 2 diabetes mellitus defined as HbA1c level between 7,5% and 10% assessed over the past 6 months
• Male or female patients from 18-75 years old inclusive
• Body Mass Index (BMI) between 25 and 40 kg/m2
• Currently treated with a basal insulin (NPH, insulin zinc or insulin detemir), plus at least 1g metformin daily, and other Oral Glucose Lowering Drug (OGLD) if any for at least 3 months
• Signed Informed consent obtained prior to any study procedures
• in the treatment period:
• HbA1c level between 7,5% and 10% assessed between week -2 and week 0
• Serum creatinine \<= 135 µmol/L in men and \<= 110 µmol/L in women
• Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) \<= 3 times the upper limit of normal
• Negative pregnancy test for women of childbearing potential

You may not qualify if:

• Type 1 diabetes mellitus
• Active proliferative diabetic retinopathy, defined as the application of photocoagulation or surgery performed within 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (confirmed by an optic fundus performed over the past 2 years)
• Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
• History of impaired hepatic function defined as Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal
• History of impaired renal function defined as serum creatinine \>135 µmol/l in men and \> 110 µmol/l in women
• History of drug or alcohol abuse
• Type 2 Diabetes Mellitus (T2DM) patients treated exclusively with OGLDs
• T2DM patients treated with an insulin other than basal insulin (Premix, rapid insulin, fast-acting insulin analogue)
• Previous treatment with insulin glulisine
• Concomitant treatment with thiazolidinediones, exenatide or pramlintide
• Treatment with systemic corticosteroids within 3 months prior to study entry
• Treatment with any investigational product within 2 months prior to study entry
• History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
• Presence of mental condition that, in the opinion of the investigator, indicates that participation in the study is not in the best interest of the patient
• Presence of geographic or social conditions that would restrict or limit the patient participation for the duration of the study

Sponsors & Collaborators

• Sanofi: lead

Study Sites (10)

Administrative office

Algiers, Algeria

Location

Administrative office

São Paulo, Brazil

Location

Administrative office

Netanya, Israel

Location

Administrative office

Beirut, Lebanon

Location

Administrative office

Col. Coyoacan, Mexico

Location

Administrative office

Casablanca, Morocco

Location

Administrative office

Lima, Peru

Location

Administrative office

Jeddah, Saudi Arabia

Location

Administrative office

Dubai, United Arab Emirates

Location

Administrative office

Caracas, Venezuela

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; insulin glulisine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine 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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 16, 2010
• Study Start: December 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 30, 2012

Record last verified: 2012-08

Locations

AE (1); IL (1); BR (1); VE (1); ME (1); PE (1); MO (1); AL (1); LE (1); SA (1)