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

NCT01892020 | Completed Phase 4 Results

• 2 other identifiers: BIASP-4058U1111-1137-2342
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test

  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.

  After 4 weeks of treatment in each treatment sequence

Secondary Outcomes (6)

• -1-hour PPG Increment Following a Standard Meal Test

  After 4 weeks of treatment in each treatment sequence

• -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

• 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

• 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

• Incidence of Hypoglycemic Episodes

  During 4 weeks of treatment in each treatment sequence

Study Arms (2)

Treatment sequence 1 (Group A)

EXPERIMENTAL

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; Drug: biphasic human insulin 50

Treatment sequence 2 (Group B)

EXPERIMENTAL

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; Drug: biphasic human insulin 50

Interventions

biphasic insulin aspart 50 DRUG

Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.

Treatment sequence 1 (Group A); Treatment sequence 2 (Group B)

biphasic human insulin 50 DRUG

Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.

Treatment sequence 1 (Group A); Treatment sequence 2 (Group B)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Beijing, Beijing Municipality, 100034, China

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Public Access to Clinical Trials
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2013
• First Posted: July 3, 2013
• Study Start: June 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 9, 2015
• Results First Posted: July 9, 2015

Record last verified: 2015-06

Locations

CN (1)