Clinical trial NCT00665808: Observational Study on Treatment Satisfaction of Levemir® Versus Protaphane® During "Real-life" Usage in Germany
Official title: Insulin Detemir (Levemir®) Versus Isophane (NPH) Insulin (Protaphane®) in Combination With Oral Antidiabetic Agents (OAD) in Patients With Diabetes Mellitus Type 2 Comparing Treatment Satisfaction, Diabetes-related and General Health-related Quality of Life, as Well as Diabetes-control
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-04-24
Enrollment: 8125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients willing and able to give signed informed consent; Patients with Type 2 diabetes mellitus; Patients, who should intensify treatment with long acting insulin in addition to their treatment with oral antidiabetic agents, due to insufficient blood glucose control; Patients with no regular use of short acting insulin (occasional use for correction is allowed); Patients with no contraindication for use of Protaphane® or Levemir®

Brief summary: This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The purpose of this NON INTERVENTIONAL OBSERVATIONAL STUDY is to primarily investigate treatment satisfaction when using Levemir® versus Protaphane® in combination with OADs in daily settings.


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained from patient before first documentation of treatment in the observational study.
* Type 2 diabetes mellitus
* Patients, who should intensify treatment with long acting insulin in addition to their treatment with oral antidiabetic agents, due to insufficient blood glucose control
* No contraindication for use of Protaphane® or Levemir®

Exclusion Criteria:

* None

Primary outcomes:
measure: treatment satisfaction (DTSQs and DTSQc)
timeFrame: over whole study duration, 24 weeks per patient
Secondary outcomes:
measure: diabetes-related quality of life (ADDQoL)
timeFrame: over whole study duration, 24 weeks per patient
measure: general health-related quality of life (EQ-5D)
timeFrame: over whole study duration, 24 weeks per patient
measure: Body weight
timeFrame: over whole study duration, 24 weeks per patient
measure: metabolic control (HbA1c, fasting morning blood glucose)
timeFrame: over whole study duration, 24 weeks per patient
measure: Insulin dose
timeFrame: over whole study duration, 24 weeks per patient
measure: concomitant diabetes therapy (OADs)
timeFrame: over whole study duration, 24 weeks per patient
measure: Hypoglycemia
timeFrame: over whole study duration, 24 weeks per patient
measure: Adverse drug reactions, ADR
timeFrame: over whole study duration, 24 weeks per patient
measure: Serious adverse drug reactions, SADR
timeFrame: over whole study duration, 24 weeks per patient
measure: Pregnancy
timeFrame: over whole study duration, 24 weeks per patient
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: