Observational Study to Observe the Efficacy of Levemir® (Insulin Detemir) in Patients With Type 2 Diabetes.
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00793273
First received: November 18, 2008
Last updated: June 28, 2012
Last verified: April 2012
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Purpose
This study is conducted in Europe. The aim of this observational study is to observe the efficacy of Levemir® treatment in patients with type 2 diabetes in everyday clinical practice in Switzerland. Furthermore the time period between diagnosis of type 2 diabetes and insulin initiation is evaluated.
| Condition | Intervention |
|---|---|
|
Diabetes Diabetes Mellitus, Type 2 |
Drug: insulin detemir |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Evaluation of Glycaemic Control After Initiation of Levemir® in Patients With Type 2 Diabetes Mellitus and Time Period Between Diagnosis of Type 2 Diabetes Mellitus and Insulin Initiation. |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Change in HbA1c of treatment [ Time Frame: after 12 to 16 weeks ] [ Designated as safety issue: No ]
- Change in FPG (fasting plasma glucose) of treatment [ Time Frame: after 12 to 16 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Occurrence of adverse events [ Time Frame: after 12 to 16 weeks ] [ Designated as safety issue: No ]
- Insulin dose and concomitant oral antidiabetic medication time period between diagnosis of type 2 diabetes and insulin initiation [ Time Frame: after 12 to 16 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 1072 |
| Study Start Date: | November 2008 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| A |
Drug: insulin detemir
Effectiveness and safety data collection in connection with the use of the drug Levemir® in daily clinical practice
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients from general practice setting who have been deemed appropriate to receive Levemir® as part of routine out-patient care by the prescribing physician.
Criteria
Inclusion Criteria:
- Patients with type 2 diabetes mellitus
- Insulin-naive or currently treated with another basal insulin
- Inclusion of patients at the discretion of the treating physician after the decision to prescribe Levemir®
Exclusion Criteria:
- Type 1 diabetes mellitus
- Patients treated with short acting or with premix insulin
- Women who are pregnant, breast feeding or have the intention to become pregnant
- Known or suspected allergy to the study product or related product
- Any exclusion criteria according to the Swiss Levemir® SPC (Summary of Product Characteristics)
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00793273 History of Changes |
| Other Study ID Numbers: | NN304-3694 |
| Study First Received: | November 18, 2008 |
| Last Updated: | June 28, 2012 |
| Health Authority: | Switzerland: Swissmedic |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013