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Completed

NCT Number: NCT00627445

Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control in Subjects With Type 2 Diabetes

This trial is conducted in Asia. The trial aims to investigate if the blood glucose control of biphasic insulin aspart 50 is at least as effective as treatment with biphasic insulin aspart 30 both in combination with metformin.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

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
  • Currently treated with premix human insulin twice daily with or without oral antidiabetic drugs for at least 3 months
  • HbA1c (Glycosylated Haemoglobin A1c) between 7.5% - 12.0% (both inclusive)
  • FPG (Fasting Plasma Glucose) higher than 7.0 mmol/L
  • BMI (Body Mass Index) 23-40 kg/sq.m (both inclusive)

Exclusion criteria

  • Metformin contraindications according to local practice
  • Systemic use of TZDs (thiazolidinediones) for more than 1 month within 6 months prior to this trial

Treatment and study plan

biphasic insulin aspart 30

Drug

Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before dinner

metformin

Drug

Tablets, 500 - 2000 mg, once, twice or three times daily

biphasic insulin aspart 50

Drug

Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before breakfast and lunch

Primary outcomes

  1. Change in Glycosylated Haemoglobin A1c (HbA1c)

    Time frame: week 0, week 16

    Change in glycosylated haemoglobin A1c (HbA1c) from week 0 (baseline) to end of treatment (week 16)

Secondary outcomes

  1. The Percentage of Subjects Achieving HbA1c Treatment Targets

    Time frame: week 16

    The percentage of subjects who after 16 weeks of treatment met the glycosylated haemoglobin A1c (HbA1c) treatment targets below 7%, or below or equal to 6.5%.

  2. Change and Daily Average in 8-point Plasma Glucose

    Time frame: week 0, week 16

    Change in 8-point plasma glucose from baseline (week 0) to at end of treatment (week 16). 8-point plasma glucose was measured at following time points: Before each meal, 120 minutes after the start of each meal, at bedtime, and at 3:00 AM in the morning. Daily average was calculated at the end of treatment.

  3. Change and Daily Average in Prandial Plasma Glucose Increment

    Time frame: week 0, week 16

    Change in prandial (mealtime) plasma glucose increment from baseline (week 0) to end of treatment (week 16). Daily average prandial plasma glucose increment was calculated at end of treatment.

  4. The Total Increase in Total Daily Insulin Dose Per Body Weight

    Time frame: week 0, week 16

    The total increase in total daily insulin dose per body weight from baseline (week 0) to end of treatment (week 16).

  5. Change in Body Weight

    Time frame: week 0, week 16

    Change in body weight from baseline (week 0) to end of treatment (week 16)

  6. Number of Hypoglycaemic Episodes

    Time frame: weeks 0-16

    Number of hypoglycaemic episodes occurring after baseline (week 0) to the end of treatment (week 16) in each treatment group. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.

  7. Number of Nocturnal Hypoglycaemic Episodes

    Time frame: weeks 0-16

    Number of nocturnal hypoglycaemic episodes occurring after baseline (week 0) to end of treatment (week 16) in each treatment group. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Effect of Biphasic Insulin Aspart 50 Compared to Biphasic Insulin Aspart 30 Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 3, 2008
Registry last updated
Oct 22, 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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