Evaluation of the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 Diabetes Mellitus (DM) Patients Uncontrolled With a Basal Insulin or Premix Once a Day

Diabetes Mellitus, Type 2 Clinical Trial

— SeLan  

Official title:

A Comparative Study to Evaluate the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 DM Patients Uncontrolled With a Basal Insulin or Premix Once a Day

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01234597
• Other study ID #: LANTU_L_05146
• Secondary ID: U1111-1116-2926
• Status: Completed
• Phase: Phase 4
• First received: November 3, 2010
• Last updated: July 12, 2016
• Start date: December 2012
• Est. completion date: April 2015

Study information

• Verified date: July 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

To evaluate the effect of prandial treatment adjustment, based on continuous blood glucose monitoring, on glucose control in type 2 diabetes patients who are not controlled by treatment with once daily basal insulin or mixed insulin, requiring treatment with basal plus regimen

Description:

The study duration for each patient is 24 weeks +/- 1 week broken down as follows:

• Run-in phase: 8 weeks

• Follow - up Period: 16 weeks

The maximal possible time window during the study is +/- one week throughout the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion criteria:

Run-in period:

1. Type 2 diabetes

2. HbA1c= 8.5% (in a test of the last month)

3. Age above 21 years

4. Patients continuously treated with basal insulin or mixed insulin once daily for the last 6 months

5. Signed informed consent form

6. Patients who according to their physician are eligible to the study

Randomization:

1. HbA1c > 7.5%

2. FPG < 130 mg/dl

Exclusion criteria:

1. Type 1 diabetes

2. Patients continuously treated with short-acting insulin or mixed insulin more than once daily for 3 weeks during the last 6 months.

3. Pregnant or breastfeeding women.

4. Patients with allergy to insulin.

5. Patients with severe diseases characterized by recurrent hospitalizations, including:

Severe renal insufficiency, severe cardiac insufficiency, active oncological disease or oncological disease requiring chemotherapy.

6. Patients with mobility difficulties and/or difficulties communicating with the investigator

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• INSULIN GLARGINE (HOE901)
Pharmaceutical form: solution for injection Route of administration: subcutaneous
• INSULIN GLULISINE (HMR1964)
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous

Locations

Country	Name	City	State
Israel	Investigational Site Number 376003	Beer Sheva
Israel	Investigational Site Number 376007	Haifa
Israel	Investigational Site Number 376004	Kfar Saba
Israel	Investigational Site Number 376012	Lod
Israel	Investigational Site Number 376013	Nazareth
Israel	Investigational Site Number 376006	Netanya
Israel	Investigational Site Number 376001	Ramat-Gan
Israel	Investigational Site Number 376009	Sachnin
Israel	Investigational Site Number 376008	Tel Aviv
Israel	Investigational Site Number 376010	Tel-Aviv
Israel	Investigational Site Number 376011	Tel-aviv

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Hemoglobin A1c (HbA1c) level		Baseline, week 24	No
Secondary	Rate of hypoglycemia		Week 24	Yes
Secondary	Changes in insulin glargine dose		Baseline, week 24	No
Secondary	Changes in insulin glulisine dose		Baseline, week 24	No