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

October 14, 2014 updated by: Novo Nordisk A/S

Effect of Biphasic Insulin Aspart 50 Compared to Biphasic Insulin Aspart 30 Both in Combination With Metformin in Chinese 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

441

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BIAsp 50-50-30
Biphasic insulin aspart 50 administered before breakfast and lunch + biphasic insulin aspart 30 at dinner combined with metformin
Drug: biphasic insulin aspart 30
Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before dinner
Drug: metformin
Tablets, 500 - 2000 mg, once, twice or three times daily
Drug: biphasic insulin aspart 50
Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before breakfast and lunch
Active Comparator: BIAsp 30-30
Biphasic insulin aspart 30 administered before breakfast and dinner combined with metformin
Drug: biphasic insulin aspart 30
Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before dinner
Drug: metformin
Tablets, 500 - 2000 mg, once, twice or three times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
week 0, week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
week 16
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.
week 0, week 16
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.
week 0, week 16
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).
week 0, week 16
Change in Body Weight
Time Frame: week 0, week 16
Change in body weight from baseline (week 0) to end of treatment (week 16)
week 0, week 16
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.
weeks 0-16
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.
weeks 0-16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

February 22, 2008

First Submitted That Met QC Criteria

February 29, 2008

First Posted (Estimate)

March 3, 2008

Study Record Updates

Last Update Posted (Estimate)

October 22, 2014

Last Update Submitted That Met QC Criteria

October 14, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-1858

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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