NCT00789711

Brief Summary

This study is conducted in Asia. The aim of this observational study is to compare the clinical safety profile and effectiveness of NovoMix® 30 and Levemir™ for the treatment of diabetes in the Philippines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,131

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 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

November 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

9 months

First QC Date

November 10, 2008

Last Update Submit

October 27, 2016

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Number of all (Major/Minor/Nocturnal) hypoglycaemic events, reported as serious adverse drug reactions.

    during 12 months of treatment

Secondary Outcomes (5)

  • HbA1c

    at the end of the study

  • FBG (Fasting Blood Glucose)

    at the end of the study

  • Average (mean) fasting plasma glucose level

    at the end of the study

  • Number of minor (including nocturnal) hypoglycaemic events

    during 12 months of treatment

  • Number of major (including nocturnal) hypoglycaemic events

    during 12 months of treatment

Study Arms (2)

A

Drug: biphasic insulin aspart 30

B

Drug: insulin detemir

Interventions

biphasic insulin aspart 30DRUG

Evaluation of the safety profile and effectiveness of biphasic insulin aspart 30 in the treatment of diabetes mellitus under normal clinical practice conditions in the Philippines

Also known as: NovoMix® 30, BIASP
A
insulin detemirDRUG

Evaluation of the safety profile and effectiveness of insulin detemir in the treatment of diabetes mellitus under normal clinical practice conditions in the Philippines

B

Eligibility Criteria

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

Any subject with diabetes mellitus who needs insulin treatment at the time of inclusion is eligible for the study, including newly diagnosed subjects who have never received insulin or an insulin analogue before

You may qualify if:

  • Patients diagnosed with type 1 or type 2 diabetes mellitus
  • Patients uncontrolled on oral antidiabetic drugs
  • Insulin naïve patients or patients currently on human insulin

You may not qualify if:

  • Subjects who are unlikely to comply with protocol requirements
  • Subjects who are previously enrolled in NovoMix® 30 and Levemir™ study
  • Subjects on NovoMix® 30 and Levemir™ therapy
  • Subjects with hypersensitivity to NovoMix® 30 or to any of the excipients
  • Subjects with hypersensitivity to Levemir™ or to any of the excipients
  • Females of child bearing potential who are pregnant, breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures are required by local law or practice
  • Contraindications and warnings specified in the current prescribing information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Manila, 1605, Philippines

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70Insulin Detemir

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 Proteins

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

November 10, 2008

First Posted

November 13, 2008

Study Start

November 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

October 31, 2016

Record last verified: 2016-10

Locations

PH(1)