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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

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ClinicalTrials.gov Identifier: NCT01215435
Recruitment Status : Completed
First Posted : October 6, 2010
Results First Posted : November 25, 2013
Last Update Posted : October 30, 2014
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 30 Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
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
Study Start Date : March 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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Iran, Islamic Republic of
Teheran, Iran, Islamic Republic of
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01215435    
Other Study ID Numbers: BIASP-3858
U1111-1116-2121 ( Other Identifier: WHO )
First Posted: October 6, 2010    Key Record Dates
Results First Posted: November 25, 2013
Last Update Posted: October 30, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Aspart
 Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Biphasic Insulins
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs