Observational Study to Evaluate Safety and Efficacy of Insulin Therapy in Type 2 Diabetes Mellitus Subjects Failing on Oral Anti-diabetic Agents

NCT00715780 | Completed

• 1 other identifier: INS-3615
• Study Type: observational
• Target: 1,667
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes and other adverse events, and to evaluate efficacy while using insulin under normal clinical practice conditions. The switch from OAD treatment to insulin therapy will be determined by physician.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Incidence of major hypoglycaemic episodes

  during 26 weeks of insulin therapy

Secondary Outcomes (12)

• Frequency and type of hypoglycaemic episodes

  during 26 weeks of insulin therapy

• Frequency and type of adverse events

  during 26 weeks of insulin therapy

• Frequency and type of adverse drug reactions

  during 26 weeks of insulin therapy

• Change in HbA1c from baseline

  during 26 weeks of insulin therapy

• Change in PPG from baseline

  during 26 weeks of insulin therapy

Study Arms (1)

A

Drug: soluble human insulin; Drug: biphasic human insulin; Drug: insulin NPH; Drug: insulin aspart; Drug: biphasic insulin aspart; Drug: insulin detemir

Interventions

soluble human insulin DRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Also known as: Actrapid®

A

biphasic human insulin DRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

A

insulin NPH DRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

A

insulin aspart DRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

A

biphasic insulin aspart DRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

A

insulin detemir DRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

A

Eligibility Criteria

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

Study Population

Type 2 diabetic patients

You may qualify if:

• Type 2 diabetes for at least 12 months and currently receiving oral anti-diabetic (OAD) treatment, whether single or combination, for at least 3 months before this study
• Insulin naive
• Poor glycaemic control on OADs and decided by the physician to start insulin therapy

You may not qualify if:

• Type 1 diabetes patients
• Patients who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
• Patients with a hypersensitivity to insulin or to any of the excipients
• Patient groups not approved in the product label

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Jakarta, 12520, Indonesia

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Insulin; biphasic human insulin 30; Insulin, Isophane; Insulin Aspart; insulin aspart, insulin aspart protamine drug combination 30:70; Insulin Detemir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting; 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: July 14, 2008
• First Posted: July 15, 2008
• Study Start: June 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: November 7, 2016

Record last verified: 2016-11

Locations

ID (1)