NCT00592969

Brief Summary

This trial is conducted in South America. The aim of this trial is to evaluate the efficacy of metformin plus biphasic insulin aspart or insulin NPH on blood glucose control in subjects with type 2 diabetes.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P50-P75 for phase_4 diabetes

Timeline
Completed

Started Dec 2003

Shorter than P25 for phase_4 diabetes

Geographic Reach
2 countries

2 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

December 3, 2003

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2004

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

11 months

First QC Date

January 2, 2008

Last Update Submit

February 22, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    after 12 weeks of treatment

Secondary Outcomes (4)

  • PPBG values

  • Glucose profiles

  • Hypoglycemia

  • Adverse events

Interventions

metforminDRUG
biphasic insulin aspartDRUG

Eligibility Criteria

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

You may qualify if:

  • Type 2 diabetes
  • Currently treated with insulin NPH or are insulin-naive
  • Body mass index (BMI) below 35.0 kg/m2
  • HbA1c between 7.5-11.0%

You may not qualify if:

  • Participation in any other clinical trial involving investigational products within the last 3 months
  • History of drug or alcohol dependence
  • Known impaired hepatic function
  • Known or suspected allergy to human insulin NPH, insulin aspart or any component of the composition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novo Nordisk Investigational Site

Mariano Acosta S/n, 5016, Argentina

Location

Novo Nordisk Investigational Site

Santa Efigênia, 30150-320, Brazil

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Metformininsulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2008

First Posted

January 14, 2008

Study Start

December 3, 2003

Primary Completion

November 2, 2004

Study Completion

November 2, 2004

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

AR(1)BR(1)