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

NCT01234597 | Completed Phase 4

• 2 other identifiers: LANTU_L_05146U1111-1116-2926
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 11

Brief 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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Changes in Hemoglobin A1c (HbA1c) level

  Baseline, week 24

Secondary Outcomes (3)

• Rate of hypoglycemia

  Week 24

• Changes in insulin glargine dose

  Baseline, week 24

• Changes in insulin glulisine dose

  Baseline, week 24

Study Arms (2)

Arm A: Without Continous Glucose Monitoring (CGM) sensor

ACTIVE COMPARATOR

Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer . Treatment phase: insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the treating physician

Drug: INSULIN GLARGINE (HOE901); Drug: INSULIN GLULISINE (HMR1964)

Arm B: Continous Glucose Monitoring (CGM) sensor

EXPERIMENTAL

Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer . Treatment phase: the patients are connected to a CGM sensor. Insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the national coordinator based on the data collected in the past previous days of CGM sensor monitoring.

Drug: INSULIN GLARGINE (HOE901); Drug: INSULIN GLULISINE (HMR1964)

Interventions

INSULIN GLARGINE (HOE901) DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Arm A: Without Continous Glucose Monitoring (CGM) sensor; Arm B: Continous Glucose Monitoring (CGM) sensor

INSULIN GLULISINE (HMR1964) DRUG

Pharmaceutical form:Solution for injection Route of administration: Subcutaneous

Arm A: Without Continous Glucose Monitoring (CGM) sensor; Arm B: Continous Glucose Monitoring (CGM) sensor

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Run-in period:
• Type 2 diabetes
• HbA1c≥ 8.5% (in a test of the last month)
• Age above 21 years
• Patients continuously treated with basal insulin or mixed insulin once daily for the last 6 months
• Signed informed consent form
• Patients who according to their physician are eligible to the study
• Randomization:
• HbA1c \> 7.5%
• FPG \< 130 mg/dl

You may not qualify if:

• Type 1 diabetes
• Patients continuously treated with short-acting insulin or mixed insulin more than once daily for 3 weeks during the last 6 months.
• Pregnant or breastfeeding women.
• Patients with allergy to insulin.
• Patients with severe diseases characterized by recurrent hospitalizations, including: Severe renal insufficiency, severe cardiac insufficiency, active oncological disease or oncological disease requiring chemotherapy.
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (11)

Investigational Site Number 376003

Beersheba, Israel

Location

Investigational Site Number 376007

Haifa, Israel

Location

Investigational Site Number 376004

Kfar Saba, 44281, Israel

Location

Investigational Site Number 376012

Lod, Israel

Location

Investigational Site Number 376013

Nazareth, Israel

Location

Investigational Site Number 376006

Netanya, Israel

Location

Investigational Site Number 376001

Ramat Gan, Israel

Location

Investigational Site Number 376009

Sakhnin, Israel

Location

Investigational Site Number 376008

Tel Aviv, Israel

Location

Investigational Site Number 376010

Tel Aviv, Israel

Location

Investigational Site Number 376011

Tel Aviv, Israel

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2010
• First Posted: November 4, 2010
• Study Start: December 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

IL (11)