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

Observational Safety and Efficacy Study in Subjects Using Insulin for the Treatment of Type 2 Diabetes Mellitus Failing on Oral Anti-diabetic Agents

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Intervention / Treatment: Drug: insulin detemir; Drug: insulin aspart; Drug: biphasic insulin aspart; Drug: soluble human insulin; Drug: biphasic human insulin; Drug: insulin NPH

• Study Type: Observational
• Enrollment (Actual): 1667

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 12520
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Type 2 diabetic patients

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

A

Drug: insulin detemir; Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation; Drug: insulin aspart; Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation; Drug: biphasic insulin aspart; Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation; Drug: soluble human insulin; Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation; Other Names: Actrapid®; Drug: biphasic human insulin; Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation; Drug: insulin NPH; Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of major hypoglycaemic episodes	during 26 weeks of insulin therapy

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Change in FPG from baseline	during 26 weeks of insulin therapy
Subjects' insulin treatment satisfaction	during 26 weeks of insulin therapy
Physicians' satisfaction with insulin therapy	during 26 weeks of insulin therapy
Weight change	at the end of the study
Percentage of patients reaching the target of HbA1c less than 7.5%	at the end of the study
Percentage of patients reaching the target of HbA1c less than 7%	at the end of the study
Percentage of patients reaching the target of HbA1c less than 6.5%	at the end of the study

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: July 14, 2008
• First Submitted That Met QC Criteria: July 14, 2008
• First Posted (Estimate): July 15, 2008

Study Record Updates

• Last Update Posted (Estimate): November 6, 2016
• Last Update Submitted That Met QC Criteria: November 4, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin Detemir; Biphasic Insulins; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
• Other Study ID Numbers: INS-3615