An Observational Study in Type 2 Diabetic Patients on Oral Antidiabetic Drugs and Basal Insulin in Near East Countries

NCT00842192 | Completed

• 1 other identifier: NN304-3735
• Study Type: observational
• Target: 2,155
• Locations: 4 countries
• Sites: 4

Brief Summary

This study is conducted in Asia. The aim of this observational study is to investigate the safety and efficacy of insulin detemir as add-on therapy in type 2 diabetic patients who are using oral antidiabetic drugs.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Change in number of hypoglycaemic events from baseline

  at 12 and 24 weeks

• HbA1c

  at 12 and 24 weeks

Secondary Outcomes (6)

• Percentage of subjects to reach HbA1c between 6.5 and 7.0%

  at 12 and 24 weeks

• Glucose variability as measured by FPG

  at 12 and 24 weeks

• Postprandial glycaemic control as measured by PPG

  at 12 and 24 weeks

• Insulin dose and number of injections

  at 12 and 24 weeks

• Body weight

  at 12 and 24 weeks

Study Arms (1)

A

Drug: insulin detemir

Interventions

insulin detemir DRUG

Insulin detemir for s.c. injection, once daily, in addition to current OAD treatment. Dose to be determined by physician.

Also known as: NN304, Levemir®

A

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 2 diabetes who is newly diagnosed or treated with OADs only is eligible for the study. The selection of the subjects as well as the treatment insulin will be at the discretion of the individual physician based on clinical judgement.

You may qualify if:

• After the physician decision has been made to use insulin detemir therapy, any subject with Type 2 diabetes who is treated with any one or more of the oral antidiabetic drug (metformin, SU, repaglinide, TZDs) is eligible for the study. The selection of the subjects will be at the discretion of the individual physician. Particular attention should be paid to the drug interactions that are listed within the product label

You may not qualify if:

• Subjects currently being treated with insulin detemir or any other insulin regimen including regular(bolus) insulin
• 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 6 months. Women of childbearing potential who are not using adequate contraceptive methods

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (4)

Novo Nordisk Investigational Site

Kfar Saba, 44425, Israel

Location

Novo Nordisk Investigational Site

Amman, 11844, Jordan

Location

Novo Nordisk Investigational Site

Amman, 11844, Lebanon

Location

Novo Nordisk Investigational Site

Karachi, Pakistan

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 ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2009
• First Posted: February 12, 2009
• Study Start: April 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: December 7, 2016

Record last verified: 2016-12

Locations

LE (1); IL (1); JO (1); PA (1)