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

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ClinicalTrials.gov Identifier: NCT00669864
Recruitment Status : Completed
First Posted : May 1, 2008
Results First Posted : July 5, 2010
Last Update Posted : April 1, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 30 Drug: metformin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 293 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin
Study Start Date : November 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Arm Intervention/treatment
Experimental: BIAsp 30-30
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
Drug: biphasic insulin aspart 30
Subcutaneous (under the skin) injection, twice daily
Other Name: NovoMix® 30
Drug: metformin
Tablets, 1000 - 2000 mg daily



Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669864


Locations
China, Beijing
Beijing, Beijing, China, 100034
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00669864     History of Changes
Other Study ID Numbers: BIASP-1960
First Posted: May 1, 2008    Key Record Dates
Results First Posted: July 5, 2010
Last Update Posted: April 1, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Metformin
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs