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Insulin
Insulin Glargine Injection Treatment in Place of Thiazolidinedione (TZD), Sulfonylurea, or Metformin in Triple Agent Therapy for Type 2 Diabetes Mellitus (T2DM) Adult Subjects With Unsatisfactory Control
Phase 4
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 weeks from baseline
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
The purpose of this study is to compare the change in hemoglobin A1c (HbA1c) from baseline to Week 12 between the 3 treatment arms.
Eligible Conditions
- Diabetes
- Type 2 Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 weeks from baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 weeks from baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia
Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Insulins + Sulfonylurea (SU) + Thiazolidinedione (TZD)Experimental Treatment2 Interventions
Arm 1: Insulin glargine administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
Group II: Insulins + Metformin (MET) + Thiazolidinedione (TZD)Experimental Treatment2 Interventions
Arm 2: Insulin glargine administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
Group III: Insulins + Metformin (MET) + Sulfonylurea (SU)Experimental Treatment2 Interventions
Arm 3: Insulin glargine administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added arms after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin glargine
FDA approved
Insulin glulisine
FDA approved
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,215 Previous Clinical Trials
4,046,746 Total Patients Enrolled
19 Trials studying Diabetes
20,597 Patients Enrolled for Diabetes
Lisa Jean-LouisStudy DirectorSanofi
2 Previous Clinical Trials
692 Total Patients Enrolled