NCT00184665

Brief Summary

This trial is conducted in Africa, Asia, Europe, Oceania, and South America. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir compared to NPH insulin administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight, and insulin antibodies and side effects).

Trial Health

98
On Track

Trial Health Score

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

Enrollment
501

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline
Completed

Started Jun 2004

Longer than P75 for phase_3 diabetes

Geographic Reach
10 countries

29 active sites

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

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

2.3 years

First QC Date

September 13, 2005

Last Update Submit

January 26, 2017

Conditions

DiabetesDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    after a two-year trial period

Secondary Outcomes (6)

  • Adverse events

  • Body weight

  • Antibodies

  • Body composition

  • Blood glucose

  • +1 more secondary outcomes

Interventions

insulin detemirDRUG
insulin NPHDRUG
insulin aspartDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes
  • Currently on basal-bolus regimen
  • BMI = 35.0 kg/m2
  • HbA1c =11.0%

You may not qualify if:

  • Proliferative retinopathy or maculopathy
  • Recurrent major hypoglycaemia
  • Cardial problems
  • Uncontrolled hypertension
  • Impaired hepatic or renal function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Novo Nordisk Investigational Site

Buenos Aires, Argentina

Location

Novo Nordisk Investigational Site

Ciudad Autonoma de Bs As, C1405CWB, Argentina

Location

Novo Nordisk Investigational Site

Ciudad Autónoma de BsAs, C1406FWY, Argentina

Location

Novo Nordisk Investigational Site

Mar del Plata, B7602CBM, Argentina

Location

Novo Nordisk Investigational Site

St Leonards, New South Wales, 2065, Australia

Location

Novo Nordisk Investigational Site

Hobart, Tasmania, 7000, Australia

Location

Novo Nordisk Investigational Site

Melbourne, Victoria, 3004, Australia

Location

Novo Nordisk Investigational Site

Darlinghurst, 2010, Australia

Location

Novo Nordisk Investigational Site

Melbourne, 3000, Australia

Location

Novo Nordisk Investigational Site

Stones Corner, 4120, Australia

Location

Novo Nordisk Investigational Site

Woodville, 5011, Australia

Location

Novo Nordisk Investigational Site

Plovdiv, 4002, Bulgaria

Location

Novo Nordisk Investigational Site

Sofia, 1431, Bulgaria

Location

Novo Nordisk Investigational Site

Zagreb, 10 000, Croatia

Location

Novo Nordisk Investigational Site

Vellore, Tamil Nadu, 632004, India

Location

Novo Nordisk Investigational Site

Chennai, 600-013, India

Location

Novo Nordisk Investigational Site

Hyderabad, 600034, India

Location

Novo Nordisk Investigational Site

Mumbai, 400 0067, India

Location

Novo Nordisk Investigational Site

Cheras, 56000, Malaysia

Location

Novo Nordisk Investigational Site

Kota Bharu, Kelantan, 16150, Malaysia

Location

Novo Nordisk Investigational Site

Skopje, 1000, North Macedonia

Location

Novo Nordisk Investigational Site

Bucharest, 020042, Romania

Location

Novo Nordisk Investigational Site

Bucharest, 020475, Romania

Location

Novo Nordisk Investigational Site

Johannesburg, Gauteng, 2193, South Africa

Location

Novo Nordisk Investigational Site

Johannesburg, Gauteng, 27 11, South Africa

Location

Novo Nordisk Investigational Site

Cape Town, Western Cape, 27 21, South Africa

Location

Novo Nordisk Investigational Site

Bloemfontein, 27 51, South Africa

Location

Novo Nordisk Investigational Site

Bornova-IZMIR, 35100, Turkey (Türkiye)

Location

Novo Nordisk Investigational Site

Istanbul, 34390, Turkey (Türkiye)

Location

Related Publications (2)

  • Bartley PC, Bogoev M, Larsen J, Philotheou A. Long-term efficacy and safety of insulin detemir compared to Neutral Protamine Hagedorn insulin in patients with Type 1 diabetes using a treat-to-target basal-bolus regimen with insulin aspart at meals: a 2-year, randomized, controlled trial. Diabet Med. 2008 Apr;25(4):442-9. doi: 10.1111/j.1464-5491.2007.02407.x.

    PMID: 18387078RESULT

  • Gschwend MH, Aagren M, Valentine WJ. Cost-effectiveness of insulin detemir compared with neutral protamine Hagedorn insulin in patients with type 1 diabetes using a basal-bolus regimen in five European countries. J Med Econ. 2009 Jun;12(2):114-23. doi: 10.3111/13696990903080344.

    PMID: 19545216RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Interventions

Insulin DetemirInsulin, IsophaneInsulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Short-Acting

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

June 1, 2004

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

January 27, 2017

Record last verified: 2017-01

Locations

BU(2)IN(4)TU(2)MY(2)CR(1)AU(7)NO(1)AR(4)RO(2)ZA(4)