Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy

NCT00598793 | Completed Phase 3

• 1 other identifier: BIASP-2163
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 27

Brief 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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c

  after 28 weeks of treatment

Secondary Outcomes (5)

• Postprandial glucose by 8-point SMBG

• Number of subjects achieving HbA1c below 7%

• Number of hypoglycemic episodes and adverse events

• Weight change

• Insulin dose

Interventions

biphasic insulin aspart DRUG

insulin glargine DRUG

metformin DRUG

pioglitazone DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (27)

Novo Nordisk Investigational Site

Concord, California, 94520, United States

Location

Novo Nordisk Investigational Site

Los Angeles, California, 90057, United States

Location

Novo Nordisk Investigational Site

Walnut Creek, California, 94598, United States

Location

Novo Nordisk Investigational Site

Melbourne, Florida, 32901, United States

Location

Novo Nordisk Investigational Site

Melbourne, Florida, 32935, United States

Location

Novo Nordisk Investigational Site

West Palm Beach, Florida, 33401, United States

Location

Novo Nordisk Investigational Site

Atlanta, Georgia, 30318, United States

Location

Novo Nordisk Investigational Site

Marietta, Georgia, 30067, United States

Location

Novo Nordisk Investigational Site

Idaho Falls, Idaho, 83404-7596, United States

Location

Novo Nordisk Investigational Site

Chicago, Illinois, 60607, United States

Location

Novo Nordisk Investigational Site

Lexington, Kentucky, 40504-2681, United States

Location

Novo Nordisk Investigational Site

Buffalo, New York, 14209, United States

Location

Novo Nordisk Investigational Site

Asheville, North Carolina, 28803, United States

Location

Novo Nordisk Investigational Site

Canton, Ohio, 44708, United States

Location

Novo Nordisk Investigational Site

Columbus, Ohio, 43203, United States

Location

Novo Nordisk Investigational Site

Medford, Oregon, 97504, United States

Location

Novo Nordisk Investigational Site

Hershey, Pennsylvania, 17033, United States

Location

Novo Nordisk Investigational Site

Greer, South Carolina, 29651, United States

Location

Novo Nordisk Investigational Site

Dallas, Texas, 75230, United States

Location

Novo Nordisk Investigational Site

Dallas, Texas, 75231, United States

Location

Novo Nordisk Investigational Site

Dallas, Texas, 75246, United States

Location

Novo Nordisk Investigational Site

Dallas, Texas, 75390-8858, United States

Location

Novo Nordisk Investigational Site

Houston, Texas, 77030, United States

Location

Novo Nordisk Investigational Site

Midland, Texas, 79707, United States

Location

Novo Nordisk Investigational Site

San Antonio, Texas, 78229, United States

Location

Novo Nordisk Investigational Site

Warrenton, Virginia, 20186, United States

Location

Novo Nordisk Investigational Site

Renton, Washington, 98055, United States

Location

Related Publications (8)

• 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. doi: 10.2337/diacare.28.2.260.

  PMID: 15677776 RESULT

• 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. doi: 10.1111/j.1463-1326.2006.00654.x.

  PMID: 17697056 RESULT

• 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. doi: 10.2337/diacare.28.11.2811. No abstract available.

  PMID: 16249569 RESULT

• 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 7;5:8. doi: 10.1186/1477-7525-5-8.

  PMID: 17286868 RESULT

• 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. 2007 Jan;9(1):103-13. doi: 10.1111/j.1463-1326.2006.00581.x.

  PMID: 17199725 RESULT

• 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. doi: 10.1016/j.ejim.2006.09.006.

  PMID: 17223044 RESULT

• 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 naive type 2 diabetes patients: cost-effectiveness analysis in the UK setting. Curr Med Res Opin. 2005 Dec;21(12):2063-71. doi: 10.1185/030079905X74989.

  PMID: 16368057 RESULT

• 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 naive type 2 diabetes patients: modelling the long-term health economic implications in a Swedish setting. Int J Clin Pract. 2008 Jun;62(6):869-76. doi: 10.1111/j.1742-1241.2008.01766.x.

  PMID: 18479280 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70; Insulin Glargine; Metformin; Pioglitazone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 23, 2008
• Study Start: November 1, 2002
• Primary Completion: March 1, 2004
• Study Completion: March 1, 2004
• Last Updated: January 9, 2017

Record last verified: 2017-01

Locations

US (27)