Clinical trial NCT01892020: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-07-03
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test
timeFrame: After 4 weeks of treatment in each treatment sequence
Secondary outcomes:
measure: -1-hour PPG Increment Following a Standard Meal Test
timeFrame: After 4 weeks of treatment in each treatment sequence
measure: -IAUC (Incremental Area Under the Curve) for PPG (0-2 Hours) Following a Standard Meal Test
timeFrame: After 4 weeks of treatment in each treatment sequence
measure: 2-hour PPG Increments Over Each of the 3 Main Meals in 8-point SMPG (Self-measured Plasma Glucose) Profile
timeFrame: After 4 weeks of treatment in each treatment sequence
measure: The Mean 2-hour PPG Increments of the 3 Main Meals in 8-point SMPG Profile
timeFrame: After 4 weeks of treatment in each treatment sequence
measure: Incidence of Hypoglycemic Episodes
timeFrame: During 4 weeks of treatment in each treatment sequence
measure: Incidence of AEs (Adverse Event)
timeFrame: During 4 weeks of treatment in each treatment sequence
Other outcomes:
Locations:
city: Beijing
country: China
state: Beijing
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: