Comparison Safety and Efficacy of Basal Insulin Lantus® (Insulin Glargine) vs NPH Insulin in Combination With Oral Antidiabetic Drugs (OADs) in Patients With Diabetes Mellitus, Type 2 (DMT2) (COBIN 2)

July 29, 2010 updated by: Sanofi

Comparison Safety and Efficacy of Basal Insulin Lantus® (Insulin Glargine) vs NPH Insulin in Combination With OADs in Patients With DMT2, Assessed by Continuous Glucose Monitoring System (CGMS). Multicentre, Prospective, Open- Label, Single Arm, Comparative Study in Patients Switched From NPH Insulin to Insulin Lantus®.

Aim of the study is to compare two treatment regimens (insulin Lantus as basal insulin vs insulin NPH) plus oral antidiabetics in type 2 diabetic patients and confirm superiority of insulin glargine. Comparison is focused on: blood glucose (BG) variability of the two treatment regimens, quality of diabetes compensation (HbA1c, FBG/Fasting blood glucose), body weight development, dose of insulin and occurrence of symptomatic hypoglycaemia and other adverse events.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

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

  • Czech Republic
      • Praha, Czech Republic
        • Sanofi-Aventis Administrative Office

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetes type 2
  • Patients treated NPH insulin with stable dosage of OADs (Oral antidiabetic drugs) for at least 2 months prior to study start and OADs treatment with metformin at least 1,7 g /day in combination with sulfonylurea or glinides.
  • Patients must have a HbA1c range of >= 4,5% ( 6,2% DCCT/Diabetes Control and Complication Trials) and <= 8% ( 9,4 % DCCT/Diabetes Control and Complication Trials)
  • Ability and willingness to perform continuous glucose monitoring system / CGMS (examination within the study)
  • Written informed consent obtained prior to enrollment in the study
  • Women are either not of childbearing potential or women of childbearing potential must not be pregnant and must use a reliable contraceptive measure for the duration of the study

Exclusion Criteria:

  1. Fasting value C peptide <= 400 pmol/l
  2. Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable rapidly progressing retinopathy that may require photocoagulation or surgery during the study.
  3. Pregnant women or women planning gravidity during clinical study protocol
  4. Breast-feeding
  5. History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
  6. Treatment with systemic corticosteroids in the 3 months prior to study entry and during study and other treatment, that can significantly have impression to glycaemia.
  7. Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
  8. Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
  9. Impaired hepatic function as shown by Alamine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal range at study entry
  10. Impaired renal function as shown by serum creatinine >/= 133 micromol/L in men and >/= 124 micromol/L in women at study entry
  11. History of drug or alcohol abuse in the last year
  12. Mental condition causing the patient unable to understand the nature, scope and possible consequences of the study
  13. Patient unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the study
  14. Use of insulin glargine outside the scope of the current SPC (Summary of Product Characteristics)

16. Patients included in other clinical studies

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single arm
Drug: insulin glargine
once daily
Other Names:
  • Lantus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change in blood glucose variability
Time Frame: before start with insulin glargine treatment and at the end of the study
before start with insulin glargine treatment and at the end of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of adverse events
Time Frame: From signing of informed consent to the end of study
From signing of informed consent to the end of study
Development of diabetes compensation - fastig blood glucose and HbA1
Time Frame: before starting therapy with Lantus and at the end of study
before starting therapy with Lantus and at the end of study
Development of weight of patients
Time Frame: Before starting Lantus vs at the end of the study
Before starting Lantus vs at the end of the study
Comparison of dose of insulins NPH vs Lantus
Time Frame: Before starting Lantus and at the end of the study
Before starting Lantus and at the end of the study

Collaborators and Investigators

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

Sponsor

Sanofi

Investigators

  • Study Director: Zuzana Priborska, MD, 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

March 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

April 10, 2008

First Submitted That Met QC Criteria

April 15, 2008

First Posted (Estimate)

April 16, 2008

Study Record Updates

Last Update Posted (Estimate)

July 30, 2010

Last Update Submitted That Met QC Criteria

July 29, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LANTU_L_02673
  • EudraCT #: 2007-003393-25

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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