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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00669864
First received: April 29, 2008
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
 Drug: biphasic insulin aspart 30
Drug: metformin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Change in HbA1c (Glycosylated Haemoglobin A1c) [ Time Frame: week 0, week 16 ] [ Designated as safety issue: No ]
    Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment)


Secondary Outcome Measures:
  • Change in 8-point Plasma Glucose Profile [ Time Frame: week 0, week 16 ] [ Designated as safety issue: No ]
    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

  • Percentage of Subjects Achieving HbA1c Less Than 7.0% [ Time Frame: week 16 ] [ Designated as safety issue: No ]
    Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below 7.0% after 16 weeks of treatment

  • Percentage of Subjects Achieving HbA1c Below or Equal to 6.5% [ Time Frame: week 16 ] [ Designated as safety issue: No ]
    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

  • Hypoglycaemic Episodes [ Time Frame: weeks 0-16 ] [ Designated as safety issue: Yes ]
    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.

  • Hypoglycaemic Episodes, Diurnal/Nocturnal [ Time Frame: weeks 0-16 ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 293
Study Start Date: November 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669864

Locations
China, Beijing
Beijing, Beijing, China, 100034
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Ruifang LIANG Novo Nordisk
Study Director: HONGFEI XU Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00669864     History of Changes
Other Study ID Numbers: BIASP-1960
Study First Received: April 29, 2008
Results First Received: April 29, 2010
Last Updated: June 5, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
 Insulin
Metformin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013