Safety and Efficacy of Insulin Detemir in Combination With OADs in Type 2 Diabetes

January 26, 2017 updated by: Novo Nordisk A/S

Evaluation of Insulin Detemir in Combination With OADs in Type 2 Diabetes Mellitus

This trial is conducted in Asia.

The aim of this trial is to evaluate the blood glucose achieved with insulin detemir as add-on to current oral antidiabetic drug (OAD) treatment in subjects with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: insulin detemir

Study Type

Interventional

Enrollment (Actual)

132

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

India
- - Ahmedabad, India, 390009
    - Novo Nordisk Investigational Site
  - Chennai, India, 600-013
    - Novo Nordisk Investigational Site
  - Chennai, India, 600010
    - Novo Nordisk Investigational Site
  - Nagpur, India, 440012
    - Novo Nordisk Investigational Site
- Kerala
  - Kochi, Kerala, India, 682041
    - Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Type 2 diabetes for at least 12 months since diagnosis
Insulin naive subjects
OAD treatment for at least 4 months with max. two OAD treatments
Body mass index below 30.0 kg/m2
HbA1c between 7.0-11.0%

Exclusion Criteria:

OAD treatment with three or more OADs
Secondary diabetes
Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator
Uncontrolled hypertension
Known or suspected allergy to trial product or related products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HbA1c Time Frame: after 20 weeks of treatment	after 20 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Fasting plasma glucose (FPG)
Incidence of adverse events
Within-subject variation
Change in body weight

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Ramachandran A, Harish K, Sundaram A, Mayur P, Sunil GS, Srishyla MV. Improved Efficacy when Insulin Detemir is added to OADs in Indian Subjects with Type 2 Diabetes. Diabetes 2006; 55 (Suppl. 1): A469 (2028-PO)

Helpful Links

Clinical Trials at Novo Nordisk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)