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Completed

NCT Number: NCT01892020

Investigating Efficacy and Safety of Biphasic Insulin Aspart 50 Twice Daily Versus Biphasic Human Insulin 50 Twice Daily Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus

This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and safety of biphasic insulin aspart 50 (BIAsp 50) twice daily versus biphasic human insulin 50 (BHI 50) twice daily, both in combination with metformin, in Chinese subjects with type 2 diabetes mellitus.

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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

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing, Beijing Municipality, 100034, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes mellitus (diagnosed clinically) for at least 12 months
  • Currently treated with premixed human insulin 50 BID for at least 3 months prior to screening visit (Visit 1)
  • Currently treated with unchanged total daily dose of at least 1500 mg metformin or maximum tolerated dose at least 1000 mg/day metformin for at least 2 months prior to screening visit
  • Glycosylated haemoglobin (HbA1c) 7.0% and 9.0% (both inclusive) (central laboratory)

Exclusion criteria

  • Treatment with any insulin secretagogue, alfa-glucosidase inhibitors, thiazolidinedione (TZD), dipeptidyl peptidase-4 (DPP-4) inhibitors and Glucagon-like peptide-1 (GLP-1) receptor agonists within the last 3 months prior to screening
  • Previous use of any insulin other than premixed human insulin 50 BID within 3 months prior to Visit 1
  • Previous use of insulin intensification treatment (premixed insulin thrice daily, basal bolus regimen, and continuous subcutaneous insulin infusion (CSII)) for more than 14 days

Treatment and study plan

biphasic insulin aspart 50

Drug

Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.

biphasic human insulin 50

Drug

Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.

Primary outcomes

  1. 2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test

    Time frame: After 4 weeks of treatment in each treatment sequence

    The 2-hour PPG increment is the difference between the plasma glucose (PG) value at 120 minutes after standard meal test and the fasting PG value.

Secondary outcomes

  1. -1-hour PPG Increment Following a Standard Meal Test

    Time frame: After 4 weeks of treatment in each treatment sequence

    The 1-h PPG increment is the difference between the plasma glucose (PG) value at 60 minutes after standard meal test and the fasting PG value.

  2. -IAUC (Incremental Area Under the Curve) for PPG (0-2 Hours) Following a Standard Meal Test

    Time frame: After 4 weeks of treatment in each treatment sequence

    AUC for plasma glucose was calculated by the trapezoidal method using 30-min sampling time points, and IAUC for PPG (0-2h) data was analyzed using a normal linear mixed model.

  3. 2-hour PPG Increments Over Each of the 3 Main Meals in 8-point SMPG (Self-measured Plasma Glucose) Profile

    Time frame: After 4 weeks of treatment in each treatment sequence

    PPG increments over each of the 3 main meals were derived from the 8-point SMPG profile as the difference between PG values available 120 minutes after meal and before meal.

  4. The Mean 2-hour PPG Increments of the 3 Main Meals in 8-point SMPG Profile

    Time frame: After 4 weeks of treatment in each treatment sequence

    Mean post prandial PG increment over all meals was derived as the mean of all available meal increments.

  5. Incidence of Hypoglycemic Episodes

    Time frame: During 4 weeks of treatment in each treatment sequence

    Treatment Emergent Hypoglycemic Episode refers to those the onset of the episode is on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment. Results are presented by American Diabetes Association classification of hypoglycemia.

  6. Incidence of AEs (Adverse Event)

    Time frame: During 4 weeks of treatment in each treatment sequence

    Treatment emergent AE (TEAE) is defined as an event that has onset date on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multi-centre, Randomised, Open-labelled, 2-sequence, 2-period Crossover Trial to Investigate the Efficacy and Safety of Biphasic Insulin Aspart 50 (BIAsp 50) Twice Daily Versus Biphasic Human Insulin 50 (BHI 50) Twice Daily Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 3, 2013
Registry last updated
Jul 9, 2015

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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