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

• Register: EUCTR
• Last refreshed on: 27 May 2013
• Main ID: EUCTR2009-010913-59-DE
• Date of registration: 06/04/2009
• Prospective Registration: Yes
• Primary sponsor: Sanofi-Aventis Deutschland GmbH
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 19/05/2009
• Target sample size: 332
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-010913-59
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
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.
10. Women of childbearing potential who will take adequate contraceptive protection such as systemic hormones (birth control pills, implant), intrauterine device (IUD), a barrier method (diaphragm with intravaginal spermicide, cervical cap, male or female condom), or whose partner is sterilized or who perform sexual abstinence.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
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.
11. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
12. Evidence of an uncooperative attitude, including poor compliance to any (antidiabetic) treatment.
13. Inability to attend the visits according to the study schedule.
14. Absence of adequate contraception
15. Current treatment because of a psychiatric disease.
16. Patients that are in a relationship of dependance with the investigator(s) and/or the sponsor.
17. Systemic corticoids > 7,5 mg prednisolon equivalent or = 7,5 mg prednisolon equivalent for less than 2 months.
18. Current participation in other clinical studies or participation in a clinical study during the last 3 months prior to participation in this study.
19. Patient underwent bariatric surgery for weight reduction (e.g. gastric banding)
20. Patient undertook major dietary changes for weight management during the last 3 months prior to participation in this study, resulting in weight reduction of at least 5kg




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Diabetes mellitus type 2

Intervention(s)

Trade Name: Lantus

Product Name: Insulin glargine
Product Code: HOE 901
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin glargine
Current Sponsor code: HOE901
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: Insuman Basal
Product Name: Human insulin
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Insulin human
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Main Objective: Investigate the impact of insulin glargine vs. NPH basal insulin on a composite diabetes related quality of life score (DRQoL), consisting of a standardized and unweighted Insulin Treatment Experience Questionnaire Score (ITEQ), the Problem Areas in Diabetes Questionnaire score (PAID) and the mental health score of the SF 12® Health Survey (SF 12®). The treatments consist of a combination therapy of oral antidiabetic agents and either insulin glargine or NPH basal insulin

Primary end point(s): Health Assessment, Patient treatment satisfaction and Quality-of-Life

Secondary Objective: Comparison of combination therapy with insulin glargine vs. NPH basal insulin from baseline to endpoint in terms of:
- Glycaemic parameters: change in HbA1c, fasting
blood glucose, 7 point glucose profile, total daily
insulin dose at endpoints
- Incidence of confirmed symptomatic hypoglycemia
(ADA criteria) as well as confirmed severe
hypoglycemia (third party assistance, according to
ADA criteria)
- Change in lipid status (total cholesterol, HDL, LDL,
triglycerides), change in body weight
- Health Assessment, Patient treatment satisfaction and
Quality-of-Life

Secondary ID(s)

LANTU_L_04079