Status:
COMPLETED
Ease of Use and Safety of the New U300 Pen Injector in Insulin-Naïve Patients With T2DM
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary Objective: To demonstrate the ease of use of the U300 pen injector in pen-naïve and insulin-naïve type 2 diabetes mellitus (T2DM) patients in a 4-week once-daily dosing regimen with HOE901-U3...
Detailed Description
The total study duration for a participants can be approximately up to 10 weeks.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with T2DM inadequately controlled with non-insulin, non-injectable anti-hyperglycemic drug(s) and for whom the Investigator/treating physicians has decided that basal insulin is appropriate.
- Signed written informed consent.
- Exclusion criteria:
- Glycated hemoglobin A1c (HbA1c) \<7.0% (\<53 mmol/mol) or \>11% (97 mmol/mol) at screening.
- Age \<18 years at the time of screening.
- Body Mass Index (BMI) \>40 kg/m2.
- Diabetes other than T2DM.
- History of T2DM for less than 1 year before screening.
- Less than 6 months anti-hyperglycemic treatment before screening.
- Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit.
- Previous treatment with Glucagon Like Peptide-1 (GLP-1) agonist.
- Patients receiving only non-insulin anti-hyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinides.
- Current or previous insulin use except for a maximum of 8 consecutive days and a total of 14 days (eg, acute illness, surgery) during the last year prior to screening.
- Any contraindication to insulin glargine (Lantus) according to the National Product labeling or any excipients.
- Any contraindication to the mandatory background non-insulin anti-hyperglycemic medication according to the respective National Product labeling.
- Latest eye examination by an ophthalmologist \>12 months prior to inclusion.
- More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months.
- Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02227212
Start Date
August 1 2014
End Date
November 1 2014
Last Update
December 3 2014
Active Locations (7)
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1
Investigational Site Number 276011
Augsburg, Germany, 86150
2
Investigational Site Number 276008
Berlin, Germany, 10115
3
Investigational Site Number 276009
Essen, Germany, 45355
4
Investigational Site Number 276002
Hamburg, Germany, 22607