Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy

Diabetes Mellitus, Type 2 Clinical Trial

— INITIATE  

Official title:

Biphasic Insulin Aspart 70/30 + Metformin Compared to Insulin Glargine + Metformin in Type 2 Diabetes Failing OAD Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598793
• Other study ID #: BIASP-2163
• Status: Completed
• Phase: Phase 3
• First received: January 11, 2008
• Last updated: January 6, 2017
• Start date: November 2002
• Est. completion date: March 2004

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to compare biphasic insulin aspart 30 plus metformin in a standard injection regimen to a standard dosing of insulin glargine plus metformin on blood glucose control in subjects with type 2 diabetes who are insulin naive and failing OAD therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Insulin naive Type 2 diabetes

• Currently treated with OADs alone or combined with other treatment for at least 3 months

• BMI below 40 kg/m2 and body weight below 125 kg

• HbA1c greater than or equal to 8%

Exclusion Criteria:

• Inability to tolerate metformin or contradictions to its use

• Pregnant, breastfeeding or intention of becoming pregnant

• Allergy to any of the trial products

• Inability or unwillingness to perform SMBG

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• biphasic insulin aspart

• insulin glargine

• metformin

• pioglitazone

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Asheville	North Carolina
United States	Novo Nordisk Investigational Site	Atlanta	Georgia
United States	Novo Nordisk Investigational Site	Buffalo	New York
United States	Novo Nordisk Investigational Site	Canton	Ohio
United States	Novo Nordisk Investigational Site	Chicago	Illinois
United States	Novo Nordisk Investigational Site	Columbus	Ohio
United States	Novo Nordisk Investigational Site	Concord	California
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Greer	South Carolina
United States	Novo Nordisk Investigational Site	Hershey	Pennsylvania
United States	Novo Nordisk Investigational Site	Houston	Texas
United States	Novo Nordisk Investigational Site	Idaho Falls	Idaho
United States	Novo Nordisk Investigational Site	Lexington	Kentucky
United States	Novo Nordisk Investigational Site	Los Angeles	California
United States	Novo Nordisk Investigational Site	Marietta	Georgia
United States	Novo Nordisk Investigational Site	Medford	Oregon
United States	Novo Nordisk Investigational Site	Melbourne	Florida
United States	Novo Nordisk Investigational Site	Melbourne	Florida
United States	Novo Nordisk Investigational Site	Midland	Texas
United States	Novo Nordisk Investigational Site	Renton	Washington
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	Walnut Creek	California
United States	Novo Nordisk Investigational Site	Warrenton	Virginia
United States	Novo Nordisk Investigational Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (8)

Brod M, Cobden D, Lammert M, Bushnell D, Raskin P. Examining correlates of treatment satisfaction for injectable insulin in type 2 diabetes: lessons learned from a clinical trial comparing biphasic and basal analogues. Health Qual Life Outcomes. 2007 Feb — View Citation

Garber AJ, Ligthelm R, Christiansen JS, Liebl A. Premixed insulin treatment for type 2 diabetes: analogue or human? Diabetes Obes Metab. 2007 Sep;9(5):630-9. Review. — View Citation

Goodall G, Jendle JH, Valentine WJ, Munro V, Brandt AB, Ray JA, Roze S, Foos V, Palmer AJ. Biphasic insulin aspart 70/30 vs. insulin glargine in insulin naïve type 2 diabetes patients: modelling the long-term health economic implications in a Swedish sett — View Citation

Raskin P, Allen E, Hollander P, Lewin A, Gabbay RA, Hu P, Bode B, Garber A; INITIATE Study Group.. Initiating insulin therapy in type 2 Diabetes: a comparison of biphasic and basal insulin analogs. Diabetes Care. 2005 Feb;28(2):260-5. — View Citation

Raskin P. Initiation of insulin therapy in patients with type 2 diabetes failing oral therapy: response to Mikhail and Cope and to Janka. Diabetes Care. 2005 Nov;28(11):2811. — View Citation

Raskin PR, Hollander PA, Lewin A, Gabbay RA, Bode B, Garber AJ; INITIATE Study Group.. Basal insulin or premix analogue therapy in type 2 diabetes patients. Eur J Intern Med. 2007 Jan;18(1):56-62. — View Citation

Ray JA, Valentine WJ, Roze S, Nicklasson L, Cobden D, Raskin P, Garber A, Palmer AJ. Insulin therapy in type 2 diabetes patients failing oral agents: cost-effectiveness of biphasic insulin aspart 70/30 vs. insulin glargine in the US. Diabetes Obes Metab. — View Citation

Valentine WJ, Palmer AJ, Lammert M, Nicklasson L, Foos V, Roze S. Long-term clinical and cost outcomes of treatment with biphasic insulin aspart 30/70 versus insulin glargine in insulin naïve type 2 diabetes patients: cost-effectiveness analysis in the UK — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		after 28 weeks of treatment	No
Secondary	Postprandial glucose by 8-point SMBG			No
Secondary	Number of subjects achieving HbA1c below 7%			No
Secondary	Number of hypoglycemic episodes and adverse events			No
Secondary	Weight change			No
Secondary	Insulin dose			No

External Links

•   Clinical Trials at Novo Nordisk