NCT00627445

Brief Summary

This trial is conducted in Asia. The trial aims to investigate if the blood glucose control of biphasic insulin aspart 50 is at least as effective as treatment with biphasic insulin aspart 30 both in combination with metformin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
441

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_3 diabetes

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

February 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 3, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 31, 2010

Completed
Last Updated

October 22, 2014

Status Verified

October 1, 2014

Enrollment Period

11 months

First QC Date

February 22, 2008

Results QC Date

March 11, 2010

Last Update Submit

October 14, 2014

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change in Glycosylated Haemoglobin A1c (HbA1c)

    Change in glycosylated haemoglobin A1c (HbA1c) from week 0 (baseline) to end of treatment (week 16)

    week 0, week 16

Secondary Outcomes (7)

  • The Percentage of Subjects Achieving HbA1c Treatment Targets

    week 16

  • Change and Daily Average in 8-point Plasma Glucose

    week 0, week 16

  • Change and Daily Average in Prandial Plasma Glucose Increment

    week 0, week 16

  • The Total Increase in Total Daily Insulin Dose Per Body Weight

    week 0, week 16

  • Change in Body Weight

    week 0, week 16

  • +2 more secondary outcomes

Study Arms (2)

BIAsp 50-50-30

EXPERIMENTAL

Biphasic insulin aspart 50 administered before breakfast and lunch + biphasic insulin aspart 30 at dinner combined with metformin

Drug: biphasic insulin aspart 30Drug: metforminDrug: biphasic insulin aspart 50

BIAsp 30-30

ACTIVE COMPARATOR

Biphasic insulin aspart 30 administered before breakfast and dinner combined with metformin

Drug: biphasic insulin aspart 30Drug: metformin

Interventions

biphasic insulin aspart 30DRUG

Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before dinner

BIAsp 30-30BIAsp 50-50-30
metforminDRUG

Tablets, 500 - 2000 mg, once, twice or three times daily

BIAsp 30-30BIAsp 50-50-30
biphasic insulin aspart 50DRUG

Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before breakfast and lunch

BIAsp 50-50-30

Eligibility Criteria

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

You may qualify if:

  • Type 2 diabetes
  • Currently treated with premix human insulin twice daily with or without oral antidiabetic drugs for at least 3 months
  • HbA1c (Glycosylated Haemoglobin A1c) between 7.5% - 12.0% (both inclusive)
  • FPG (Fasting Plasma Glucose) higher than 7.0 mmol/L
  • BMI (Body Mass Index) 23-40 kg/sq.m (both inclusive)

You may not qualify if:

  • Metformin contraindications according to local practice
  • Systemic use of TZDs (thiazolidinediones) for more than 1 month within 6 months prior to this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Beijing, Beijing Municipality, 100034, China

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
Public Access to Clinical Trials
Organization
Novo Nordisk A/S
clinicaltrials@novonordisk.com

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

February 22, 2008

First Posted

March 3, 2008

Study Start

February 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

October 22, 2014

Results First Posted

March 31, 2010

Record last verified: 2014-10

Locations

CN(1)