Observational Study on Levemir® in Obese Diabetic Patients

NCT00849342 | Completed

• 1 other identifier: NN304-3708
• Study Type: observational
• Target: 580
• Locations: 2 countries
• Sites: 2

Brief Summary

This study is conducted in Europe. The aim of this observational study is to investigate the effect of switch from other basal insulin treatments to Levemir® on body weight in obese diabetic patients. A local extension will be conducted in Slovenia in order to reach the planned 400 patients for the sub-analysis of Slovenian patients. Included in the study is a retrospective part to evaluate the weight progress since initiation of insulin treatment of another basal insulin and/or oral antidiabetic drugs (OAD) and/or bolus insulin therapy. Retrospective data will be collected at baseline and at approximately 6 and 12 months before starting insulin detemir therapy.

Conditions

Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in body weight and BMI

  during 12 months of treatment

Secondary Outcomes (7)

• Change in body weight at different BMI subgroups

  at insulin start, 12 and 6 months before treatment and after 3, 6, 9 and 12 months of treatment

• Change in waist perimeter

  from insulin start and after 6 and 12 months of treatment

• Change in FPG (Fasting Plasma Glucose)

  from 12 and 6 months before treatment after 6 and 12 months of treatment

• Change in HbA1C

  from insulin start and 12 and 6 months before treatment and after 6 and 12 months of treatment

• Change in number of hypoglycaemic events during 4 weeks proceeding routine visits

  after 6 and 12 months of treatment

Study Arms (1)

A

Drug: insulin detemir

Interventions

insulin detemir DRUG

Safety and effectiveness (weight and HbA1c) data collection in connection with the use of the drug Levemir® in daily clinical practice.

A

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from both general and speciality practice settings who have been deemed appropriate to receive Levemir® because of weight increase on other insulin therapies, and as part of routine out-patient care by the prescribing physician.

You may qualify if:

• Diabetes mellitus (Type 1 or type 2)
• BMI greater than 27 kg/m\^2, or more than 3 kg weight increase since start of insulin therapy

You may not qualify if:

• Subjects currently being treated with insulin detemir
• Subjects who were previously enrolled in this study;
• Subjects with a hypersensitivity to insulin detemir or to any of the excipients.
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months Female patients will be reminded to use adequate contraceptive during the study, where is relevant.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

Unknown Facility

Alphen aan den Rijn, Netherlands

Location

Unknown Facility

Ljubljana, SI-1000, Slovenia

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Interventions

Insulin Detemir

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2009
• First Posted: February 23, 2009
• Study Start: December 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: January 1, 2013
• Last Updated: August 15, 2014

Record last verified: 2014-07

Locations

SL (1); NL (1)