Health Assessment, Patient treatment satisfaction and Quality-of-Life in insulin-naive type 2 diabetes Patients uncontrolled on OHA treatment initiating basal insulin therapy with either insulin glargine or NPH insulin added to therapies with oral hypoglycemic agents. A multicenter, prospective, crossover, open randomized clinical phase-IV trial. - HAPPY

Sanofi-Aventis Deutschland GmbH0 sites332 target enrollmentApril 6, 2009

Overview

No summary available.

Registry

who.int

Start Date

April 6, 2009

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Written Informed Consent must be obtained for all patients before commencement in the study at visit 1 (Appendix A: Informed Consent document). Subjects meeting all of the following inclusion criteria will be considered for enrollment into the study:
•1\.Patients with type 2 diabetes mellitus (no history of ketoacidosis) according to ADA criteria (24\)
•2\.Treatment with one or maximum two oral antihyperglycemic agents on a stable dosage during at least at the last 4 weeks from the following substances/substance classes: metformin, sulfonylurea, DPP\-IV inhibitors.
•3\.No pre\-treatment with any insulin in the last 3 months before the study.
•4\.HbA1c value between \= 7\.0% and \= 10\.0%.
•5\.FBG \= 120 mg/dl (6\.7 mmol/l).
•6\.Men and women aged between 18\-80 years inclusive.
•7\.Body mass index \> 22 kg/m²and \<40 kg/m².
•8\.Ability to read and understand German language.
•9\.Ability and willingness to follow a tight antidiabetic therapy and to perform blood glucose self monitoring on a regular basis.

•1\.Patients with type 1 diabetes mellitus.
•2\.Any history of ketoacidosis
•3\.Pregnancy (as determined by pregnancy serum test at visit 1\).
•4\.Prior treatment with insulin within the last 3 months before the study
•5\.Treatment with more than two oral agents within the last 4 weeks or continuous treatment with thiazolidinediones or GLP\-1 receptor agonists.
•6\.History of drug or alcohol abuse.
•7\.Diabetic retinoathy with surgical treatment (laser photocoagulation or vitrectomy) in the last 3 months prior to study entry or which may require surgical treatment within 3 months of study entry.
•8\.Following pancreatectomy.
•9\.Impaired hepatic function, as shown by, but not limited to, SGPT (ALAT) or SGOT (ASAT), above 2x the upper limit of normal measured at visit 1\.
•10\.Impaired renal function, as shown by, but not limited to, serum creatinine \> 177 µmol/l (\> 2\.0 mg/dl) measured at visit 1\.