Investigating Efficacy and Safety of Biphasic Insulin Aspart 50 Twice Daily Versus Biphasic Human Insulin 50 Twice Daily Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01892020
First received: June 28, 2013
Last updated: June 16, 2015
Last verified: June 2015
  Purpose

This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and safety of biphasic insulin aspart 50 (BIAsp 50) twice daily versus biphasic human insulin 50 (BHI 50) twice daily, both in combination with metformin, in Chinese subjects with type 2 diabetes mellitus.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 50
Drug: biphasic human insulin 50
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-centre, Randomised, Open-labelled, 2-sequence, 2-period Crossover Trial to Investigate the Efficacy and Safety of Biphasic Insulin Aspart 50 (BIAsp 50) Twice Daily Versus Biphasic Human Insulin 50 (BHI 50) Twice Daily Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test [ Time Frame: After 4 weeks of treatment in each treatment sequence ] [ Designated as safety issue: No ]
    The 2-hour PPG increment is the difference between the plasma glucose (PG) value at 120 minutes after standard meal test and the fasting PG value.


Secondary Outcome Measures:
  • -1-hour PPG Increment Following a Standard Meal Test [ Time Frame: After 4 weeks of treatment in each treatment sequence ] [ Designated as safety issue: No ]
    The 1-h PPG increment is the difference between the plasma glucose (PG) value at 60 minutes after standard meal test and the fasting PG value.

  • -IAUC (Incremental Area Under the Curve) for PPG (0-2 Hours) Following a Standard Meal Test [ Time Frame: After 4 weeks of treatment in each treatment sequence ] [ Designated as safety issue: No ]
    AUC for plasma glucose was calculated by the trapezoidal method using 30-min sampling time points, and IAUC for PPG (0-2h) data was analyzed using a normal linear mixed model.

  • 2-hour PPG Increments Over Each of the 3 Main Meals in 8-point SMPG (Self-measured Plasma Glucose) Profile [ Time Frame: After 4 weeks of treatment in each treatment sequence ] [ Designated as safety issue: No ]
    PPG increments over each of the 3 main meals were derived from the 8-point SMPG profile as the difference between PG values available 120 minutes after meal and before meal.

  • The Mean 2-hour PPG Increments of the 3 Main Meals in 8-point SMPG Profile [ Time Frame: After 4 weeks of treatment in each treatment sequence ] [ Designated as safety issue: No ]
    Mean post prandial PG increment over all meals was derived as the mean of all available meal increments.

  • Incidence of Hypoglycemic Episodes [ Time Frame: During 4 weeks of treatment in each treatment sequence ] [ Designated as safety issue: No ]
    Treatment Emergent Hypoglycemic Episode refers to those the onset of the episode is on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment. Results are presented by American Diabetes Association classification of hypoglycemia.

  • Incidence of AEs (Adverse Event) [ Time Frame: During 4 weeks of treatment in each treatment sequence ] [ Designated as safety issue: No ]
    Treatment emergent AE (TEAE) is defined as an event that has onset date on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment.


Enrollment: 161
Study Start Date: June 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment sequence 1 (Group A)
Group A will receive BIAsp 50 BID during the first 4 weeks (treatment period 1) then switch to BHI 50 BID for further 4 weeks (treatment period 2)
Drug: biphasic insulin aspart 50
Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.
Drug: biphasic human insulin 50
Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.
Experimental: Treatment sequence 2 (Group B)
Group B will receive BHI 50 BID during the first 4 weeks (treatment period 1), then switch to BIAsp 50 BID for further 4 weeks (treatment period 2)
Drug: biphasic insulin aspart 50
Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.
Drug: biphasic human insulin 50
Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus (diagnosed clinically) for at least 12 months
  • Currently treated with premixed human insulin 50 BID for at least 3 months prior to screening visit (Visit 1)
  • Currently treated with unchanged total daily dose of at least 1500 mg metformin or maximum tolerated dose at least 1000 mg/day metformin for at least 2 months prior to screening visit
  • Glycosylated haemoglobin (HbA1c) 7.0% and 9.0% (both inclusive) (central laboratory)

Exclusion Criteria:

  • Treatment with any insulin secretagogue, alfa-glucosidase inhibitors, thiazolidinedione (TZD), dipeptidyl peptidase-4 (DPP-4) inhibitors and Glucagon-like peptide-1 (GLP-1) receptor agonists within the last 3 months prior to screening
  • Previous use of any insulin other than premixed human insulin 50 BID within 3 months prior to Visit 1
  • Previous use of insulin intensification treatment (premixed insulin thrice daily, basal bolus regimen, and continuous subcutaneous insulin infusion (CSII)) for more than 14 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01892020

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
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01892020     History of Changes
Other Study ID Numbers: BIASP-4058, U1111-1137-2342
Study First Received: June 28, 2013
Results First Received: May 4, 2015
Last Updated: June 16, 2015
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Biphasic Insulins
Insulin
Insulin Aspart
Insulin, Globin Zinc
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2015