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)

NCT00659477 | Completed Phase 4

• 2 other identifiers: LANTU_L_02673EudraCT #: 2007-003393-25
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• The change in blood glucose variability

  before start with insulin glargine treatment and at the end of the study

Secondary Outcomes (4)

• Occurrence of adverse events

  From signing of informed consent to the end of study

• Development of diabetes compensation - fastig blood glucose and HbA1

  before starting therapy with Lantus and at the end of study

• Development of weight of patients

  Before starting Lantus vs at the end of the study

• Comparison of dose of insulins NPH vs Lantus

  Before starting Lantus and at the end of the study

Study Arms (1)

single arm

EXPERIMENTAL

Drug: insulin glargine

Interventions

insulin glargine DRUG

once daily

Also known as: Lantus

single arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Fasting value C peptide \<= 400 pmol/l
• 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.
• Pregnant women or women planning gravidity during clinical study protocol
• Breast-feeding
• History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
• 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.
• Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
• Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
• 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
• Impaired renal function as shown by serum creatinine \>/= 133 micromol/L in men and \>/= 124 micromol/L in women at study entry
• History of drug or alcohol abuse in the last year
• Mental condition causing the patient unable to understand the nature, scope and possible consequences of the study
• Patient unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the study
• Use of insulin glargine outside the scope of the current SPC (Summary of Product Characteristics)
• \. Patients included in other clinical studies

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Prague, Czechia

Location

Related Publications (1)

• Zdarska DJ, Kvapil M, Rusavy Z, Krcma M, Broz J, Krivska B, Kadlecova P. Comparison of glucose variability assessed by a continuous glucose-monitoring system in patients with type 2 diabetes mellitus switched from NPH insulin to insulin glargine: the COBIN2 study. Wien Klin Wochenschr. 2014 Apr;126(7-8):228-37. doi: 10.1007/s00508-014-0508-6. Epub 2014 Feb 22.

  PMID: 24563017 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

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

• Zuzana Priborska, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 10, 2008
• First Posted: April 16, 2008
• Study Start: March 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: July 30, 2010

Record last verified: 2010-07

Locations

CZ (1)