Skip to main content
OpenTrials
Completed

NCT Number: NCT01215435

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tehran, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

biphasic insulin aspart 30

Drug

Administered subcutaneously (under the skin) once daily, before breakfast. The trial has 3 treatment phases for both treatment arms

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 6, 2010
Registry last updated
Oct 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.