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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01203111
First received: September 14, 2010
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

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. Percentage of patients with HbA1c < 7% at week 24.
  2. Percentage of patients with HbA1c < 7% and no symptomatic nocturnal hypoglycemia event at week 24.
  3. Fasting Plasma Glucose (FPG) and 7-point Self Monitoring of Blood Glucose (SMBG) at week 0, week 12 and week 24.
  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. Systolic and diastolic blood pressure, heart rate, weight change will be measured at week 0, week 12 and week 24.
  6. Number of patients suffering hypoglycemias (asymptomatic, symptomatic, nocturnal symptomatic, severe and nocturnal severe) will be evaluated during the treatment period. 7-Adverse events.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: INSULIN GLARGINE
Drug: INSULIN GLULISINE
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Intensive Insulin Therapy With Insulin Glulisine in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in HbA1c level for patients with addition of glulisine at week 12 [ Time Frame: between week 12 and week 24 (end of treatment period) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with HbA1c level < 7% [ Time Frame: at week 24 (end of treatment period) ] [ Designated as safety issue: No ]
  • Percentage of patients with HbA1c level < 7% and no symptomatic nocturnal hypoglycemia event [ Time Frame: at week 24 (end of treatment period) ] [ Designated as safety issue: No ]
  • Fasting Plasma Glucose [ Time Frame: at week 0, week 12 and week 24 ] [ Designated as safety issue: No ]
  • 7-point Self Monitoring of Blood Glucose [ Time Frame: at week 0, week 12 and week 24 ] [ Designated as safety issue: No ]
  • Daily dose of insulin glargine [ Time Frame: at week 24 (end of treatment period) ] [ Designated as safety issue: No ]
  • Daily dose of insulin glulisine [ Time Frame: at week 24 (end of treatment period) ] [ Designated as safety issue: No ]
  • Systolic / diastolic blood pressure, heart rate, weight change [ Time Frame: from week 0 (baseline) to week 24 (end of treatment period) ] [ Designated as safety issue: No ]
  • Hypoglycemia (asymptomatic, symptomatic, nocturnal symptomatic, severe and nocturnal severe) [ Time Frame: from week 0 (from baseline) to week 24 (end of treatment) ] [ Designated as safety issue: Yes ]

Enrollment: 207
Study Start Date: December 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive insulin regimen
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
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day in the evening at bedtime
Other Name: Lantus SoloStar
Drug: INSULIN GLULISINE
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day, 0 to 15 minutes before the main meal
Other Name: Apidra SoloStar
Experimental: insulin regimen
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
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day in the evening at bedtime
Other Name: Lantus SoloStar

Detailed Description:

The study is divided in 3 periods:

  1. a 2-week run-in period,
  2. a 12-week treatment period 1
  3. a 12-week treatment period 2 study treatment duration per patient: 24 weeks study duration per patient: 26 weeks
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • in the run-in period:

    1. Uncontrolled Type 2 diabetes mellitus defined as HbA1c level between 7,5% and 10% assessed over the past 6 months
    2. Male or female patients from 18-75 years old inclusive
    3. Body Mass Index (BMI) between 25 and 40 kg/m2
    4. 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
    5. Signed Informed consent obtained prior to any study procedures
  • in the treatment period:

    1. HbA1c level between 7,5% and 10% assessed between week -2 and week 0
    2. Serum creatinine <= 135 µmol/L in men and <= 110 µmol/L in women
    3. Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) <= 3 times the upper limit of normal
    4. Negative pregnancy test for women of childbearing potential

Exclusion criteria:

  1. Type 1 diabetes mellitus
  2. 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)
  3. Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
  4. History of impaired hepatic function defined as Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal
  5. History of impaired renal function defined as serum creatinine >135 µmol/l in men and > 110 µmol/l in women
  6. History of drug or alcohol abuse
  7. Type 2 Diabetes Mellitus (T2DM) patients treated exclusively with OGLDs
  8. T2DM patients treated with an insulin other than basal insulin (Premix, rapid insulin, fast-acting insulin analogue)
  9. Previous treatment with insulin glulisine
  10. Concomitant treatment with thiazolidinediones, exenatide or pramlintide
  11. Treatment with systemic corticosteroids within 3 months prior to study entry
  12. Treatment with any investigational product within 2 months prior to study entry
  13. History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
  14. 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
  15. Presence of geographic or social conditions that would restrict or limit the patient participation for the duration of the study
  16. Pregnant or breast feeding women
  17. Women of childbearing potential not protected by effective contraceptive method of birth control

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: NCT01203111

Locations
Algeria
Administrative office
Algiers, Algeria
Brazil
Administrative office
Sao Paulo, Brazil
Israel
Administrative office
Natanya, Israel
Lebanon
Administrative office
Beirut, Lebanon
Mexico
Administrative office
Col. Coyoacan, Mexico
Morocco
Administrative office
Casablanca, Morocco
Peru
Administrative office
Lima, Peru
Saudi Arabia
Administrative office
Jeddah, Saudi Arabia
United Arab Emirates
Administrative office
Dubaï, United Arab Emirates
Venezuela
Administrative office
Caracas, Venezuela
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01203111     History of Changes
Other Study ID Numbers: LANTU_R_05048, U1111-1116-3517
Study First Received: September 14, 2010
Last Updated: August 29, 2012
Health Authority: Mexico: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Insulin glulisine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014