Observational Study of the Predictability of Levemir® in Terms of Metabolic Control, Change of Body Weight and Hypos

NCT01542489 | Completed

• 1 other identifier: NN304-1927
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the effect of Levemir® (insulin detemir) on glycaemic control, weight and incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c (glycosylated haemoglobin)

Secondary Outcomes (6)

• Change in 7-point blood glucose variability

• Change in body weight

• Insulin dose

• Number of injections

• Number of hypoglycaemic episodes

Study Arms (2)

IDet + IAsp users

Drug: insulin detemir; Drug: insulin aspart

IDet + HI users

Drug: insulin detemir; Drug: human soluble insulin

Interventions

insulin detemir DRUG

Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any

IDet + HI users; IDet + IAsp users

insulin aspart DRUG

Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any

IDet + IAsp users

human soluble insulin DRUG

Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any

IDet + HI users

Eligibility Criteria

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

Study Population

Any subject with type 1 or type 2 diabetes treated with insulin in whom at the discretion of the participating physicians it was decide to switch insulin treatment to the long-acting insulin analogue Levemir® in combination with either insulin aspart (NovoRapid®) or human insulin (Actrapid®)

You may qualify if:

• Any subject with type 1 or type 2 diabetes treated with insulin in whom at the discretion of the participating physicians it was decide to switch insulin treatment to the long-acting insulin analogue insulin detemir (Levemir®) in combination with either insulin aspart (NovoRapid®) or human insulin (Actrapid®)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Bratislava, 811 05, Slovakia

Location

Related Publications (1)

• Emil Martinka; Improved Glycemic Control and Weight Loss in Slovakian Patients Switching from NPH to Insulin Detemir; 2049-PO; 69th Scientific Sessions (2009); American Diabetes Association

  RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

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

Interventions

Insulin Detemir; Insulin Aspart

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; Insulin, Short-Acting

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: March 2, 2012
• Study Start: October 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

SL (1)