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Completed

NCT Number: NCT00669864

Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin

This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin.

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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 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
  • Currently treated with basal insulin once or twice daily with or without oral anti-diabetic drugs (OADs) for at least 3 months
  • HbA1c (glycosylated haemoglobin A1c) within the range of 7.5% to10.0% ( both inclusive)
  • BMI (Body Mass Index) maximum 40 kg/m2

Exclusion criteria

  • Metformin contraindications according to local practice
  • Systemically treated with TZDs (thiazolidinediones) for more than one month within 6 months prior to this trial

Treatment and study plan

biphasic insulin aspart 30

Drug

Subcutaneous (under the skin) injection, twice daily

Other names: NovoMix® 30

metformin

Drug

Tablets, 1000 - 2000 mg daily

Primary outcomes

  1. Change in HbA1c (Glycosylated Haemoglobin A1c)

    Time frame: week 0, week 16

    Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment)

Secondary outcomes

  1. Change in 8-point Plasma Glucose Profile

    Time frame: week 0, week 16

    Summary of change in 8-point plasma glucose profile by week and time. The 8 time points measured were: Before each meal (breakfast, lunch and dinner), at 2 hours after each meal (breakfast, lunch and dinner), at bedtime, and at 3 AM, measured over 16 weeks of treatment

  2. Percentage of Subjects Achieving HbA1c Less Than 7.0%

    Time frame: week 16

    Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below 7.0% after 16 weeks of treatment

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

    Time frame: week 16

    Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below or equal to 6.5% after 16 weeks of treatment

  4. Hypoglycaemic Episodes

    Time frame: weeks 0-16

    Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment). 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.

  5. Hypoglycaemic Episodes, Diurnal/Nocturnal

    Time frame: weeks 0-16

    Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment) during the day (diurnal) and the night (nocturnal).

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 1, 2008
Registry last updated
Apr 1, 2016

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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