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

Diabetes Mellitus, Type 2 Clinical Trial

— CHANGING  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203111
• Other study ID #: LANTU_R_05048
• Secondary ID: U1111-1116-3517
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2010
• Last updated: August 29, 2012
• Start date: December 2010
• Est. completion date: July 2012

Study information

• Verified date: August 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
Algeria	Administrative office	Algiers
Brazil	Administrative office	Sao Paulo
Israel	Administrative office	Natanya
Lebanon	Administrative office	Beirut
Mexico	Administrative office	Col. Coyoacan
Morocco	Administrative office	Casablanca
Peru	Administrative office	Lima
Saudi Arabia	Administrative office	Jeddah
United Arab Emirates	Administrative office	Dubaï
Venezuela	Administrative office	Caracas

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Algeria,  Brazil,  Israel,  Lebanon,  Mexico,  Morocco,  Peru,  Saudi Arabia,  United Arab Emirates,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c level for patients with addition of glulisine at week 12		between week 12 and week 24 (end of treatment period)	No
Secondary	Percentage of patients with HbA1c level < 7%		at week 24 (end of treatment period)	No
Secondary	Percentage of patients with HbA1c level < 7% and no symptomatic nocturnal hypoglycemia event		at week 24 (end of treatment period)	No
Secondary	Fasting Plasma Glucose		at week 0, week 12 and week 24	No
Secondary	7-point Self Monitoring of Blood Glucose		at week 0, week 12 and week 24	No
Secondary	Daily dose of insulin glargine		at week 24 (end of treatment period)	No
Secondary	Daily dose of insulin glulisine		at week 24 (end of treatment period)	No
Secondary	Systolic / diastolic blood pressure, heart rate, weight change		from week 0 (baseline) to week 24 (end of treatment period)	No
Secondary	Hypoglycemia (asymptomatic, symptomatic, nocturnal symptomatic, severe and nocturnal severe)		from week 0 (from baseline) to week 24 (end of treatment)	Yes