Observational Study in Type 2 Diabetics Failing on Oral Antidiabetic Therapy and Starting on Insulin Treatment

NCT00865397 | Completed

• 1 other identifier: NN304-3699
• Study Type: observational
• Target: 1,032
• Locations: 1 country
• Sites: 2

Brief Summary

This study is conducted in Europe. The aim of this observational study is to evaluate glycaemic control in subjects with type 2 diabetes using once daily Levemir® as initiation of insulin therapy in Hungary.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  after 24 weeks

Secondary Outcomes (4)

• Percentage of subjects to reach HbA1c below 7.0% and equal to or more than 6.5%

  after 12 weeks and 24 weeks

• Change in FPG (Fasting Plasma Glucose)

  after 12 weeks and 24 weeks

• Change in body weight

  after 12 weeks and 24 weeks

• Change in waist and hip circumference

  after 12 weeks and 24 weeks

Study Arms (1)

A

Drug: insulin detemir

Interventions

insulin detemir DRUG

Effectiveness data collection in connection with the use of the drug Levemir® in daily clinical practice.

Also known as: Levemir®, NN304

A

Eligibility Criteria

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

Study Population

A non-randomised sample of approximately 1000 subjects with OAD failure from specialists - diabetologists practice who have been deemed appropriate to receive insulin detemir as add-on to OAD therapy as part of routine out-patient care by the prescribing physician.

You may qualify if:

• Patient with type 2 diabetes inadequately controlled by OAD therapy based on the discretion of individual physician
• Patient willing to sign informed consent
• Particular attention should be paid to age limits, indications and contraindications and the drug interactions that are listed within the product labels

You may not qualify if:

• Subjects with diagnosed type 1 diabetes mellitus
• Subjects who are unlikely to comply with observational plan, (e.g., uncooperative attitude, inability to return for further visits)
• Subjects with hypersensitivity to Levemir® or to any of the ingredients
• Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 months.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

Novo Nordisk Investigational Site

Budapest, 1025, Hungary

Location

Novo Nordisk Investigational Site

Budapest, H-1025, Hungary

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Insulin Detemir

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine 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 CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2009
• First Posted: March 19, 2009
• Study Start: February 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: November 23, 2016

Record last verified: 2016-11

Locations

HU (2)