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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:
ClinicalTrials.gov Identifier:
NCT01215435
First Posted: October 6, 2010
Last Update Posted: October 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11 [ Time Frame: Week 0, Week 11 ]
    Estimated mean change from baseline in HbA1c after 11 weeks of treatment


Secondary Outcome Measures:
  • Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36 [ Time Frame: Week 0, Week 36 ]
    Estimated mean change from baseline in FPG after 36 weeks of treatment

  • Number of Treatment Emergent Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 36 ]
    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.


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: Pre-breakfast BIAsp 30 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: Pre-dinner BIAsp 30 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01215435


Locations
Iran, Islamic Republic of
Teheran, Iran, Islamic Republic of
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01215435     History of Changes
Other Study ID Numbers: BIASP-3858
U1111-1116-2121 ( Other Identifier: WHO )
First Submitted: October 1, 2010
First Posted: October 6, 2010
Results First Submitted: September 23, 2013
Results First Posted: November 25, 2013
Last Update Posted: October 30, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs