Efficacy and Safety of Biphasic Insulin Aspart 30 in Combination With Metformin in Type 2 Diabetes

NCT00619697 | Completed Phase 4

• 1 other identifier: BIASP-1564
• Study Type: interventional
• Target: 260
• Locations: 6 countries
• Sites: 51

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy on blood glucose control in type 2 diabetes.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c

  after 26 weeks of treatment

Secondary Outcomes (5)

• HbA1c

  after 16 weeks of treatment

• Plasma glucose profiles

• Change in body mass index

• Incidence of hypoglycaemic episodes

• Safety profile

Interventions

biphasic insulin aspart DRUG

Also known as: BIASP, NovoMix 30, NovoLog 70/30 Mix

insulin glargine DRUG

metformin DRUG

glimepiride DRUG

Eligibility Criteria

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

You may qualify if:

• Type 2 diabetes for at least 6 months
• Insulin naive. Short term insulin treatment (7 days or less within the last 6 months) is allowed
• Previous treatment with oral antidiabetic drugs for at least 4 months
• Judged by the investigator to be eligible for an insulin analogue plus oral antidiabetic drug treatment regimen
• BMI below 40 kg/m2
• HbA1c between 7-12%
• Able and willing to perform self-plasma glucose monitoring

You may not qualify if:

• The receipt of any other investigational drug within 4 weeks before screening
• A history of drug or alcohol abuse within the last 12 months
• Severe, uncontrolled hypertension
• Known or suspected allergy to trial products or related products

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (54)

Novo Nordisk Investigational Site

Ebreichsdorf, 2483, Austria

Location

Novo Nordisk Investigational Site

Feldkirch, 6807, Austria

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Novo Nordisk Investigational Site

Graz, 8036, Austria

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Novo Nordisk Investigational Site

Horn, A 3580, Austria

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Novo Nordisk Investigational Site

Oberpullendorf, 7350, Austria

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Novo Nordisk Investigational Site

Salzburg, 5010, Austria

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Novo Nordisk Investigational Site

Villach, A 9500, Austria

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Novo Nordisk Investigational Site

Waidhofen A.d. Thaya, A 3830, Austria

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Novo Nordisk Investigational Site

Brno, 65691, Czechia

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Novo Nordisk Investigational Site

Liberec, 46001, Czechia

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Novo Nordisk Investigational Site

Augsburg, 86150, Germany

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Novo Nordisk Investigational Site

Castrop-Rauxel, 44577, Germany

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Novo Nordisk Investigational Site

Deggingen, 73326, Germany

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Novo Nordisk Investigational Site

Duisburg, 47053, Germany

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Novo Nordisk Investigational Site

Erlangen, 91054, Germany

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Novo Nordisk Investigational Site

Eschweiler, 52249, Germany

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Novo Nordisk Investigational Site

Friedrichsthal, 66299, Germany

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Novo Nordisk Investigational Site

Fulda, 36037, Germany

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Novo Nordisk Investigational Site

Hamburg, 22119, Germany

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Novo Nordisk Investigational Site

Hamburg, 22177, Germany

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Novo Nordisk Investigational Site

Herne, 44623, Germany

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Novo Nordisk Investigational Site

Kippenheim, 77971, Germany

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Novo Nordisk Investigational Site

Lauffen am Neckar, 74348, Germany

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Novo Nordisk Investigational Site

Leverkusen, 51377, Germany

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Novo Nordisk Investigational Site

Ludwigsburg, 71634, Germany

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Novo Nordisk Investigational Site

Ludwigshafen, 67059, Germany

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Novo Nordisk Investigational Site

Ludwigshafen, 67063, Germany

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Novo Nordisk Investigational Site

Mannheim, 68161, Germany

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Novo Nordisk Investigational Site

Mannheim, 68199, Germany

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Novo Nordisk Investigational Site

Marburg, 35037, Germany

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Novo Nordisk Investigational Site

Marburg, 35043, Germany

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Novo Nordisk Investigational Site

Mülheim, 45468, Germany

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Novo Nordisk Investigational Site

Neunkirchen, 66539, Germany

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Novo Nordisk Investigational Site

Ostercappeln, 49179, Germany

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Novo Nordisk Investigational Site

Pritzwalk, 16928, Germany

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Novo Nordisk Investigational Site

Rosenheim, 83022, Germany

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Novo Nordisk Investigational Site

Viernheim, 68519, Germany

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Novo Nordisk Investigational Site

Weil der Stadt, 71263, Germany

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Novo Nordisk Investigational Site

Weiskirchen, 66709, Germany

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Novo Nordisk Investigational Site

Witten, 58452, Germany

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Novo Nordisk Investigational Site

Witten, 58456, Germany

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Novo Nordisk Investigational Site

Budapest, 1041, Hungary

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Novo Nordisk Investigational Site

Eger, 3300, Hungary

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Novo Nordisk Investigational Site

Szekszárd, 7100, Hungary

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Novo Nordisk Investigational Site

Częstochowa, 42-200, Poland

Location

Novo Nordisk Investigational Site

Gdynia, 81-366, Poland

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Novo Nordisk Investigational Site

Lublin, 20 011, Poland

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Novo Nordisk Investigational Site

Otwock, 05-400, Poland

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Novo Nordisk Investigational Site

Poznan, 61-696, Poland

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Novo Nordisk Investigational Site

L'ubochna, 03491, Slovakia

Location

Novo Nordisk Investigational Site

Martin, 036 59, Slovakia

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Novo Nordisk Investigational Site

Celje, 3000, Slovenia

Location

Novo Nordisk Investigational Site

Ljubljana, 1000, Slovenia

Location

Novo Nordisk Investigational Site

Maribor, 2000, Slovenia

Location

Related Publications (1)

• Kann PH, Wascher T, Zackova V, Moeller J, Medding J, Szocs A, Mokan M, Mrevlje F, Regulski M. Starting insulin therapy in type 2 diabetes: twice-daily biphasic insulin Aspart 30 plus metformin versus once-daily insulin glargine plus glimepiride. Exp Clin Endocrinol Diabetes. 2006 Oct;114(9):527-32. doi: 10.1055/s-2006-949655.

  PMID: 17115351 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; glimepiride

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

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 21, 2008
• Study Start: December 1, 2003
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: January 6, 2017

Record last verified: 2017-01

Locations

SL (2); HU (3); PL (5); DE (31); AU (8); CZ (2)