Liraglutide or Insulin in Real Life Usage in Patients With Diabetes Mellitus Type 2
This study is enrolling participants by invitation only.
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01484262
First received: November 22, 2011
Last updated: April 4, 2013
Last verified: April 2013
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Purpose
This study is conducted in Europe. The intention of this health service research study is to obtain data from daily routine to evaluate the quality of life and the costs of the disease for patients with type 2 diabetes mellitus.
| Condition | Intervention |
|---|---|
|
Diabetes Diabetes Mellitus, Type 2 |
Drug: liraglutide Drug: insulin |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Liraglutide or Insulin in Real Life Usage in Patients With Diabetes Mellitus Type 2 |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Diabetes-related quality of life assessed by ADDQoL (Audit of Diabetes-Dependent Quality of Life) [ Time Frame: At the end of the observational period (52 weeks) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Total cost of patient's diseases [ Time Frame: At the end of the observational period (52 weeks) ] [ Designated as safety issue: No ]
- Total cost of patient education [ Time Frame: At the end of the observational period (52 weeks) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1500 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Liraglutide |
Drug: liraglutide
Patients will be treated according to routine clinical practice at the discretion of the treating physician according to current labelling.
|
| Any insulin |
Drug: insulin
Any insulin in any device available on the market may be used by patients as part of routine clinical practice according to current labelling.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients diagnosed with type 2 diabetes mellitus, currently treated with oral antidiabetics (OADs), who need treatment intensification with insulin or liraglutide due to inadequate blood glucose control.
Criteria
Inclusion Criteria:
- Informed consent obtained before any study-related activities. (Study-related activities are any procedures related to recording of data according to the protocol)
- Patients willing and able to give signed consent on matching patient data with sick fund data
- Patients diagnosed with type 2 diabetes mellitus, currently treated with oral antidiabetic medication, who need treatment intensification with insulin or liraglutide (Victoza®) due to inadequate blood glucose control
- Patient is a member of the involved sick fund (AOK Plus)
Exclusion Criteria:
- Known or suspected contra-indication to the relevant study product according to current SPC
- Previous participation in this study
- History of type 1 diabetes mellitus
- Previous insulin treatment excluding emergency administration (treatment duration up to a maximum of 3 days)
- Previous treatment with liraglutide
- History of diabetic gastroparesis, diabetic precoma or diabetic ketoacidosis
- Progressive fatal disease
- Any reason in judgement of the treating physician that precludes study participation e.g. lack of compliance, safety concerns, alcohol or drug abuse
- Patients without legal capacity
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT01484262 History of Changes |
| Other Study ID Numbers: | NN2211-3962, U1111-1123-5044 |
| Study First Received: | November 22, 2011 |
| Last Updated: | April 4, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin Glucagon-Like Peptide 1 |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013