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) - Full Text View

Purpose

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	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: insulin glargine	Phase IV

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Insulin Insulin glargine Dextrose Insulin, isophane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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®.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

The change in blood glucose variability [ Time Frame: before start with insulin glargine treatment and at the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurrence of adverse events [ Time Frame: From signing of informed consent to the end of study ] [ Designated as safety issue: Yes ]
Development of diabetes compensation - fastig blood glucose and HbA1 [ Time Frame: before starting therapy with Lantus and at the end of study ] [ Designated as safety issue: No ]
Development of weight of patients [ Time Frame: Before starting Lantus vs at the end of the study ] [ Designated as safety issue: Yes ]
Comparison of dose of insulins NPH vs Lantus [ Time Frame: Before starting Lantus and at the end of the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	March 2008
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
single arm: Experimental	Drug: insulin glargine once daily

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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:

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)

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659477

Contacts


Contact: Public Registry GMA		publicregistrygma@sanofi-aventis.com

Locations


Czech Republic
	Sanofi-aventis	Recruiting
	Prague, Czech Republic

Sponsors and Collaborators

Sanofi-Aventis

Investigators


Study Director:	Zuzana Priborska, MD	Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	LANTU_L_02673, EudraCT #: 2007-003393-25
First Received:	April 10, 2008
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00659477
Health Authority:	Czech Republic: State Institute for Drug Control