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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)

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ClinicalTrials.gov Identifier: NCT00659477
Recruitment Status : Completed
First Posted : April 16, 2008
Last Update Posted : July 30, 2010
Sponsor:
Information provided by:
Sanofi

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: insulin glargine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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®.
Study Start Date : March 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: single arm Drug: insulin glargine
once daily
Other Name: Lantus




Primary Outcome Measures :
  1. The change in blood glucose variability [ Time Frame: before start with insulin glargine treatment and at the end of the study ]

Secondary Outcome Measures :
  1. Occurrence of adverse events [ Time Frame: From signing of informed consent to the end of study ]
  2. Development of diabetes compensation - fastig blood glucose and HbA1 [ Time Frame: before starting therapy with Lantus and at the end of study ]
  3. Development of weight of patients [ Time Frame: Before starting Lantus vs at the end of the study ]
  4. Comparison of dose of insulins NPH vs Lantus [ Time Frame: Before starting Lantus and at the end of the study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659477


Locations
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Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Zuzana Priborska, MD Sanofi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00659477     History of Changes
Other Study ID Numbers: LANTU_L_02673
EudraCT #: 2007-003393-25
First Posted: April 16, 2008    Key Record Dates
Last Update Posted: July 30, 2010
Last Verified: July 2010
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Insulin, Isophane
Isophane Insulin, Human
Isophane insulin, beef
Hypoglycemic Agents
Physiological Effects of Drugs