Comparison of Two Biphasic Insulin Aspart 30 Treatment Regimens in Subjects With Type 2 Diabetes Not Achieving HbA1c Treatment Targets on OADs Alone

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

An Open Labelled, Randomised, Parallel Trial; Efficacy and Safety Comparison of Two Different Biphasic Insulin Aspart 30 Treatment Initiation Regimens Followed by Intensification in Subjects With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets on OADs Alone in Iran

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01215435
• Other study ID #: BIASP-3858
• Secondary ID: U1111-1116-2121
• Status: Completed
• Phase: Phase 4
• First received: October 1, 2010
• Last updated: October 22, 2014
• Start date: March 2011
• Est. completion date: September 2012

Study information

• Verified date: October 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health and Medical Education
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• biphasic insulin aspart 30
Administered subcutaneously (under the skin) once daily, before breakfast. The trial has 3 treatment phases for both treatment arms
• biphasic insulin aspart 30
Administered subcutaneously (under the skin) once daily, before dinner. The trial has 3 treatment phases for both treatment arms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36	Estimated mean change from baseline in FPG after 36 weeks of treatment	Week 0, Week 36	No
Secondary	Number of Treatment Emergent Hypoglycaemic Episodes	A hypoglycaemic episode will be defined as treatment emergent if the onset of the episode is on or after the first day of trial product, and no later than the last day on trial product.	Week 0 to Week 36	No

External Links

•   Clinical Trials at Novo Nordisk