EUCTR2014-001253-16-DE
Active, not recruiting
Phase 1
A multi-center, open-label, single-arm, multiple dose study with HOE901-U300 to assess the Ease of Use and Safety of a new U300 pen injector in insulin-naïve patients with T2DM
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type 2 diabetes mellitus
- Sponsor
- Sanofi-aventis recherche & développement
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with T2DM inadequately controlled with non\-insulin, noninjectable antihyperglycemic drug(s) and for whom the
- •Investigator/treating physicians has decided that basal insulin is appropriate.
- •Signed written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 30
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 10
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.
Outcomes
Primary Outcomes
Not specified
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