Comparison of Insulin Glargine/Insulin Glulisine Regimen to Insulin Aspart/Insulin Aspart Protamine 30/70 in Type 2 Diabetes Mellitus Patients (T2DM) (B to B)

July 5, 2013 updated by: Sanofi

Comparison of a Basal Plus (Insulin Glargine/Insulin Glulisine) Regimen to Biphasic Insulin (InsulinAspart/Insulin Aspart Protamine 30/70) in T2DM Patients Who Require Insulin Intensification After Basal Insulin Optimization.

Primary Objective:

To demonstrate the non-inferiority of hemoglobin A1c (HbA1c) control at six months between the basal plus one and the biphasic insulin regimen.

Secondary Objective:

To demonstrate favorable outcome for basal plus over biphasic insulin when it comes to comparing when both hemoglobin A1c (HbA1c) target goal achievement and non-hypoglycemic event is taken into account.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Sub-optimally controlled Type 2 Diabetes Mellitus (T2DM) patients treated with insulin glargine for a minimum of 3 months:

    • Sub-optimal: HbA1c level >7% and fasting blood glucose <130mg/dL
  2. Male or Female ≥18 years old
  3. Body Mass Index (BMI) <40
  4. 10% ≥HbA1c ≥7%
  5. If taking Oral anti-diabetics (OADs), must be on stable dose for at least 1 months
  6. Patients willing to sign data release consent form

Exclusion criteria:

  1. Diabetes other than T2DM
  2. Enrolled in other clinical trials
  3. Previous treatment with an insulin other than insulin glargine
  4. Treatment with Glucagon-like peptide-1 (GLP-1) receptor agonists or with Di Peptidyl Peptidase 4 (DPP-IV) inhibitors
  5. Pregnant or lactating women
  6. Contraindicated to Lantus (insulin glargine) / Apidra (insulin glulisine) / Novomix 30 (insulin aspart)
  7. Treatment with systemic corticoid steroids within the last 3 months prior to study enter
  8. Treatment with any investigational product within the last 3 months prior to study entry

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1: Basal plus
Insulin glargine with dosage adjustment determined according to the mean value of the last three days Fasting Blood Glucose (FBG) Insulin glulisine, at initial dosing of 4IU, then weekly adjusted according to the mean value of the last three days PostPrandial Blood Glucose (PPBG)
Drug: INSULIN GLARGINE
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily
Other Names:
  • Lantus
Drug: INSULIN GLULISINE
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily
Other Names:
  • Apidra
Active Comparator: group 2: Biphasic insulin
Insulin aspart/insulin aspart protamine 30/70 (novomix 30) given twice daily and titrated weekly (before breakfast and dinner) according to the lowest of three previous days' pre-meal levels (both breakfast and dinner). Target is 70 mg/dL < Pre-meal blood glucose (dinner and breakfast).
Drug: Insulin aspart
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: twice daily
Other Names:
  • NovoMix 30

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in hemoglobin A1c level (HbA1c)
Time Frame: At 6 months of treatment
At 6 months of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of hypoglycemic events (total, severe, nocturnal)
Time Frame: from baseline to the study endpoint (over 6 months of treatment)
from baseline to the study endpoint (over 6 months of treatment)
Proportion of patients with HbA1c < 7%
Time Frame: from baseline to the study endpoint (over 6 months of treatment)
from baseline to the study endpoint (over 6 months of treatment)
Change in body weight
Time Frame: from baseline to the study endpoint (over 6 months of treatment)
from baseline to the study endpoint (over 6 months of treatment)
Reactive Oxidative Stress (ROS) level changes
Time Frame: from baseline to the study endpoint (over 6 months of treatment)
from baseline to the study endpoint (over 6 months of treatment)
Change in Quality of Life
Time Frame: from baseline to the study endpoint (over 6 months of treatment)
from baseline to the study endpoint (over 6 months of treatment)
Continuous Glucose Monitoring System (CGMS) data
Time Frame: at baseline, 3 and 6 months
at baseline, 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

September 30, 2010

First Submitted That Met QC Criteria

September 30, 2010

First Posted (Estimate)

October 1, 2010

Study Record Updates

Last Update Posted (Estimate)

July 8, 2013

Last Update Submitted That Met QC Criteria

July 5, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LANTU_L_04867
  • U1111-1117-2786 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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