NCT01215435

Brief Summary

This trial is conducted in Asia. The aim of this trial is to compare the glycaemic control when subjects initiate a biphasic insulin aspart 30 treatment followed by an intensified treatment if treatment target of HbA1c below 7% is not reached by OAD (oral anti-diabetic drugs) alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
245

participants targeted

Target at P75+ for phase_4 diabetes

Timeline
Completed

Started Mar 2011

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

First Submitted

Initial submission to the registry

October 1, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 25, 2013

Completed
Last Updated

October 30, 2014

Status Verified

October 1, 2014

Enrollment Period

1.5 years

First QC Date

October 1, 2010

Results QC Date

September 23, 2013

Last Update Submit

October 22, 2014

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11

    Estimated mean change from baseline in HbA1c after 11 weeks of treatment

    Week 0, Week 11

Secondary Outcomes (2)

  • Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36

    Week 0, Week 36

  • Number of Treatment Emergent Hypoglycaemic Episodes

    Week 0 to Week 36

Study Arms (2)

Pre-breakfast BIAsp 30

EXPERIMENTAL
Drug: biphasic insulin aspart 30

Pre-dinner BIAsp 30

EXPERIMENTAL
Drug: biphasic insulin aspart 30

Interventions

biphasic insulin aspart 30DRUG

Administered subcutaneously (under the skin) once daily, before breakfast. The trial has 3 treatment phases for both treatment arms

Pre-breakfast BIAsp 30

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with type 2 diabetes for a minimum of 6 months prior to Visit 1
  • HbA1c at least 7.0 % - maximum 11 % at screening
  • Subject is insulin naïve (short-term insulin treatment of up to 14 days is allowed)
  • An antidiabetic regimen that has been stable for at least 3 months prior to screening
  • An antidiabetic regimen that includes a minimum of 2 OADs
  • OADs dosed at least 50% of the maximum recommended dose

You may not qualify if:

  • Known or suspected hypersensitivity to trial product(s) or related products
  • Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
  • The receipt of any investigational medicinal product within one month prior to this trial
  • Suffer from a life threatening disease (cancer)
  • Cardiac disease: class III or IV congestive heart failure (CHF), unstable angina, and or any myocardial infarction (treated or untreated) within 6 months prior to screening
  • Hepatic insufficiency (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) above 2 times the central laboratory's upper reference limit)
  • Renal insufficiency (serum creatinine above 1.6 mg/dl for males; 1.4 mg/dl for females
  • Recurrent hypoglycaemia or hypoglycaemic unawareness
  • Anemia (haemoglobin below 10 mg/dl)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tehran, Iran

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

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

Study Record Dates

First Submitted

October 1, 2010

First Posted

October 6, 2010

Study Start

March 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

October 30, 2014

Results First Posted

November 25, 2013

Record last verified: 2014-10

Locations

IR(1)