NCT00687063

Brief Summary

The study is conducted in Asia. The aim of this observational study is to evaluate the weight change from baseline while using Levemir® in subjects with type 2 diabetes mellitus under normal clinical practice conditions in India.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,008

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

May 27, 2008

Last Update Submit

October 31, 2023

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Weight change from baseline

    after 26 weeks

Secondary Outcomes (7)

  • Number of serious adverse events

    after 26 weeks

  • Number of all adverse events

    after 26 weeks

  • Number of all hypoglycemic episodes (24 hr, daytime and nocturnal)

    after 26 weeks

  • HbA1c change from baseline

    after 26 weeks

  • FBG (Fasting Blood Glucose) change from baseline

    after 26 weeks

  • +2 more secondary outcomes

Study Arms (1)

A

Drug: insulin detemir

Interventions

insulin detemirDRUG

Start dose and frequency of insulin detemir is to be decided by physician. The choice of patient is also at the discretion of Physician

Also known as: Levemir®
A

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Type 2 diabetics

You may qualify if:

  • Any subject with type 2 diabetes

You may not qualify if:

  • Subjects with a hypersensitivity to insulin detemir or any of its excipient
  • Children below 6 years
  • Subjects who are pregnant, lactating or planning to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Bangalore, 560001, India

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Insulin Detemir

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452), MD

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2008

First Posted

May 30, 2008

Study Start

April 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

November 2, 2023

Record last verified: 2023-10

Locations

IN(1)