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: May 20, 2014
Last verified: May 2014

June 28, 2013
May 20, 2014
June 2013
May 2014   (final data collection date for primary outcome measure)
2-hours 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 ]
Same as current
Complete list of historical versions of study NCT01892020 on ClinicalTrials.gov Archive Site
  • -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 ]
  • -IIAUC (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 ]
  • 2-hours 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 ]
  • 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 ]
  • Incidence of hypoglycaemic episodes [ Time Frame: During 4 weeks of treatment in each treatment sequence ] [ Designated as safety issue: No ]
  • Incidence of AEs (adverse event) [ Time Frame: During 4 weeks of treatment in each treatment sequence ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 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 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)
    Interventions:
    • Drug: biphasic insulin aspart 50
    • Drug: biphasic human insulin 50
  • 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)
    Interventions:
    • Drug: biphasic insulin aspart 50
    • Drug: biphasic human insulin 50
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
161
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01892020
BIASP-4058, U1111-1137-2342
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP