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Completed

NCT Number: NCT01278160

Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens in Subjects With Type 2 Diabetes: An Extension to Trial BIASP-3756

This trial is conducted in Asia. The aim of the trial is to compare the effect on glycaemic control of biphasic insulin aspart 30 twice daily with two different dosage split regimens for Chinese subjects with type 2 diabetes who did not achieve the treatment target of a glycosylated haemoglobin A1c (HbA1c) below 7% in trial BIASP-3756 (NCT01123980).

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing, Beijing Municipality, 100029, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Finalised 24 weeks of treatment with once daily BIAsp 30 or insulin glargine in combination with metformin and glimepiride in trial BIAsp-3756
  • HbA1c above or equal to 7.0%
  • Body Mass Index (BMI) below or equal to 40.0 kg/m2

Exclusion criteria

  • Known hypoglycaemia unawareness or recurrent major hypoglycaemic episodes in trial BIAsp-3756
  • Known proliferative retinopathy or maculopathy requiring acute treatment
  • Any disease or condition which the Investigator (trial physician) feels would interfere with the trial

Treatment and study plan

biphasic insulin aspart 30

Drug

Administered subcutaneously (under the skin), twice daily with a dosage of 2/3 and 1/3 total daily dose before breakfast and before dinner, in combination with metformin.

metformin

Drug

Tablets 500 mg administered orally with meals. Pre-trial dose and regimen unchanged

Primary outcomes

  1. Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline

    Time frame: Week 0, week 16

Secondary outcomes

  1. 9-point SMPG (Self Measured Plasma Glucose) Profile

    Time frame: Week 16

    A 9-point SMPG profile included measurements before and 120 minutes after start of breakfast, lunch and main evening meal, measurements prior to bedtime and at 2:00 -4:00 a.m., and one before breakfast the following day

  2. Percentage of Subjects Achieving HbA1c Below 7.0%

    Time frame: Week 16

    The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment

  3. Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%

    Time frame: Week 16

    The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment

  4. Number of Treatment Emergent Hypoglycaemic Episodes

    Time frame: Weeks 0-16

    Treatment emergent hypoglycaemic episodes (hypos): those that happened between treatment and one day after last drug day. Hypos summarised based on American Diabetes Association classification. Severe hypos: episodes requiring another person to actively administer resuscitative actions. Minor hypos: episodes with symptoms with plasma glucose below 3.1 mmol/L (56 mg/dL) handled by the subject, or any asymptomatic plasma glucose below 3.1 mmol/L (56 mg/dL). Diurnal period: between 06:00 and 23:59 (both included). Nocturnal period: between 00:00 and 05:59 a.m. (both included).

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

An Extension Trial of BIAsp-3756, Explorative Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens on the Effect of Glycaemic Control in Chinese Type 2 Diabetes Patients

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 17, 2011
Registry last updated
Oct 27, 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.

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