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®.

Sanofi1 site in 1 country117 target enrollmentMarch 2008

ConditionsDiabetes Mellitus, Type 2

Interventionsinsulin glargine

Drugsinsulin glargine

Overview

Phase: Phase 4
Intervention: insulin glargine
Conditions: Diabetes Mellitus, Type 2
Sponsor: Sanofi
Enrollment: 117
Locations: 1
Primary Endpoint: The change in blood glucose variability
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

June 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sanofi

Eligibility 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

Arms & Interventions

single arm

Intervention: insulin glargine

Outcomes

Primary Outcomes

The change in blood glucose variability

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

Secondary Outcomes

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)