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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00627445
First received: February 22, 2008
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 30
Drug: metformin
Drug: biphasic insulin aspart 50
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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


Secondary Outcome Measures:
  • The Percentage of Subjects Achieving HbA1c Treatment Targets [ Time Frame: week 16 ] [ Designated as safety issue: No ]
    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%.

  • Change and Daily Average in 8-point Plasma Glucose [ Time Frame: week 0, week 16 ] [ Designated as safety issue: No ]
    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.

  • Change and Daily Average in Prandial Plasma Glucose Increment [ Time Frame: week 0, week 16 ] [ Designated as safety issue: No ]
    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.

  • The Total Increase in Total Daily Insulin Dose Per Body Weight [ Time Frame: week 0, week 16 ] [ Designated as safety issue: No ]
    The total increase in total daily insulin dose per body weight from baseline (week 0) to end of treatment (week 16).

  • Change in Body Weight [ Time Frame: week 0, week 16 ] [ Designated as safety issue: No ]
    Change in body weight from baseline (week 0) to end of treatment (week 16)

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

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


Enrollment: 441
Study Start Date: February 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00627445

Locations
China, Beijing
Beijing, Beijing, China, 100034
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Xu Hongfei, MSc Novo Nordisk (China) Pharmaceuticals Co., Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00627445     History of Changes
Other Study ID Numbers: BIASP-1858
Study First Received: February 22, 2008
Results First Received: March 11, 2010
Last Updated: June 15, 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 April 15, 2014