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 A/S
ClinicalTrials.gov Identifier:
NCT01215435
First received: October 1, 2010
Last updated: September 23, 2013
Last verified: September 2013
  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:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 A/S
Investigators
Study Director: Meltem Telaferli, Dr. Novo Nordisk Saglik Ürünleri Tic. Ltd. St
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01215435     History of Changes
Other Study ID Numbers: BIASP-3858, U1111-1116-2121
Study First Received: October 1, 2010
Results First Received: September 23, 2013
Last Updated: September 23, 2013
Health Authority: Iran: Ministry of Health and Medical Education

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

ClinicalTrials.gov processed this record on October 22, 2014