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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01215435
First received: October 1, 2010
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
 Drug: biphasic insulin aspart 30
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c change [ Time Frame: after 11 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in FPG (Fasting Plasma Glucose) [ Time Frame: week 0, week 36 ] [ Designated as safety issue: No ]
  • Number of hypoglycaemic episodes [ Time Frame: continously measured weeks 0-36 ] [ Designated as safety issue: No ]

Enrollment: 245
Study Start Date: March 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: biphasic insulin aspart 30
Administered subcutaneously (under the skin) once daily, before breakfast. The trial has 3 treatment phases for both treatment arms
Experimental: B Drug: biphasic insulin aspart 30
Administered subcutaneously (under the skin) once daily, before dinner. The trial has 3 treatment phases for both treatment arms

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with type 2 diabetes for a minimum of 6 months prior to Visit 1
  • HbA1c between 7.0%-11%
  • 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 trial start
  • An antidiabetic regimen that includes a minimum of 2 OADs
  • OADs dosed at 50% or more 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: NYHA class III or IV CHF, unstable angina, and or any myocardial infarction (treated or untreated) within 6 months prior to trial start
  • Impaired liver function
  • Renal insufficiency
  • Recurrent hypoglycaemia or hypoglycaemic unawareness
  • Anaemia (haemoglobin below 10 mg/dl)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01215435

Locations
Iran, Islamic Republic of
Teheran, Iran, Islamic Republic of
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Volkan Manga Novo Nordisk Saglik Ürünleri Tic. Ltd. St
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01215435     History of Changes
Other Study ID Numbers: BIASP-3858, U1111-1116-2121
Study First Received: October 1, 2010
Last Updated: December 19, 2012
Health Authority: Iran: Ministry of Health and Medical Education

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
 Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013