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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Drug: biphasic insulin aspart 50; Drug: biphasic human insulin 50

• Registration Number: NCT01892020
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-28
• Study First Submitted QC: 2013-06-28
• Study First Posted: 2013-07-03
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Results First Submitted: 2015-05-04
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-16
• Last Update Submitted: 2015-06-16
• Results First Posted: 2015-07-09
• Last Update Posted: 2015-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment sequence 1 (Group A)	biphasic human insulin 50	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)
Treatment sequence 1 (Group A)	biphasic insulin aspart 50	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)
Treatment sequence 2 (Group B)	biphasic insulin aspart 50	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)
Treatment sequence 2 (Group B)	biphasic human insulin 50	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)

Primary Outcome Measures

Name	Time	Method
2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test	After 4 weeks of treatment in each treatment sequence	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

Name	Time	Method
The Mean 2-hour PPG Increments of the 3 Main Meals in 8-point SMPG Profile	After 4 weeks of treatment in each treatment sequence	Mean post prandial PG increment over all meals was derived as the mean of all available meal increments.
Incidence of AEs (Adverse Event)	During 4 weeks of treatment in each treatment sequence	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.
Incidence of Hypoglycemic Episodes	During 4 weeks of treatment in each treatment sequence	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.
-1-hour PPG Increment Following a Standard Meal Test	After 4 weeks of treatment in each treatment sequence	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	After 4 weeks of treatment in each treatment sequence	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	After 4 weeks of treatment in each treatment sequence	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.