A Phase 4 interventional study of Insulin Glargine (HOE901) [Lantus] and Glimepiride in Diabetes Mellitus, Type 2, sponsored by Sanofi. Completed at 87 sites in 17 countries. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-08-21.
Sponsored by Sanofi · Phase 4, Interventional, and Treatment
Primary Objective:
To demonstrate the superiority of insulin glargine over insulin NPH (Neutral Protamin Hagedornon) the change in HbA1c from baseline to the end of the treatment period.
Secondary Objective:
To compare between treatment groups:
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 708 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Before randomization (common with arm 2): 2 weeks of Screening phase: Oral Anti Diabetics (OAD) 2 weeks of Run-In phase: switch of OAD (Sulfonylurea (except Glimepiride), glinides or alpha-glucosidase inhibitor) to Glimepiride After randomization: 36 weeks of study treatment phase: Insulin Glargine + OAD(s) at stable dose
Drug: Insulin Glargine (HOE901) [Lantus] · Drug: Glimepiride
Before randomization (common with arm 1): 2 weeks of Screening phase: Oral Anti Diabetics (OAD) 2 weeks of Run-In phase: switch of OAD (Sulfonylurea (except Glimepiride), glinides or alpha-glucosidase inhibitor) to Glimepiride After randomization: 36 weeks of study treatment phase: NPH + OAD(s) at stable dose
Drug: Glimepiride · Drug: human insulin [NPH]
100 Units/ml solution for injection in a pre-filled pen SoloStar® (3 ml)
tablets of 1 and 2 mg
100 IU/ml suspension for injection in a prefilled pen OptiSet® (3 ml)
HbA1c
Time frame: Recorded at baseline (week 0), week 12, week 24 and week 36
Self-monitored fasting plasma glucose (FPG)
Time frame: Before baseline (week 0), weeks 12, 24 and 36
8-points profiles
Time frame: The week before baseline, at 12, 24 and 36 weeks
Episodes of hypoglycemia
Time frame: From the week -2 to the week 36
Daily doses of insulin
Time frame: At week 1, week 2, week 3, week 4, week 6, week 8, week 10, week 12, week 14, week 16, week 20, week 24, week 28, week 32, week 36
Need of additional prandial insulin
Time frame: At week 24
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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