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Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
biphasic insulin aspart
insulin glargine
metformin
glimepiride
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 2 diabetes
  • Treatment with OADs (Oral Anti-Diabetic Drugs) for more than 6 months
  • Ongoing stable treatment with metformin for at least 2 months
  • Ongoing stable treatment with minimum half maximal dose of any insulin secretagogue for at least 2 months
  • Insulin naive
  • HbA1c (glycosylated haemoglobin A1c) between 7.0% and 11.0% (inclusive of both values)

Exclusion Criteria:

  • Metformin contraindication according to local practice
  • TZD (thiazolidinedione) treatment for the last 5 months before trial start
  • Systemic treatment with any corticosteroid 3 months before trial start
  • Any disease or condition which according to the Investigator would interfere with the trial

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BIAsp 30

Glargine

Arm Description

Outcomes

Primary Outcome Measures

Glycosylated Haemoglobin A1c (HbA1c)
Glycosylated Haemoglobin A1c measured in blood samples after 26 weeks of treatment.

Secondary Outcome Measures

9-point Self-measured Plasma Glucose Profiles
Glycaemic control measured by 9-point self-measured plasma glucose (SMPG) profiles. The 9 time points for self-measurement during the day were: Before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 AM, and before breakfast the following day. Hypoglycaemia episodes were defined as major or minor. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL.
Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c)
The number of subjects achieving the treatment target for glycosylated haemoglobin A1c after 26 weeks treatment. The treatment targets were: HbA1c <= 6.5% of haemoglobin and HbA1c < 7% of haemoglobin.
Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat)
Subjects assessed the burden, efficacy, symptoms and overall score in the treatment satisfaction questionnaire, Diab MedSat (Diabetes Medication Satisfaction questionnaire). The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale.
Number of Hypoglycaemic Episodes
Total number of hypoglycaemic episodes experienced in each treatment arm. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.
Number of Subjects Reporting Treatment Emergent Adverse Events
Number of subjects reporting treatment emergent adverse events during the trial (from week 0 to week 26). Adverse events were reported as treatment emergent if they occurred from the date of first insulin trial product administration up to and including the date of last insulin trial product administration.

Full Information

First Posted
May 3, 2007
Last Updated
January 5, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00469092
Brief Title
Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes
Official Title
A Multi-national, Open-labelled, Randomised, Parallel Group, 4 Week run-in and 26 Weeks Treat-to-target Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Insulin naïve Subjects With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is conducted in Africa, Asia, Europe, Oceania and South America. This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIAsp 30
Arm Type
Experimental
Arm Title
Glargine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart
Intervention Description
Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Description
Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
Tablets, 2550 mcg. Administered once daily.
Intervention Type
Drug
Intervention Name(s)
glimepiride
Intervention Description
Tablets 2 mg. 4, 6 or 8 mg administered once daily.
Primary Outcome Measure Information:
Title
Glycosylated Haemoglobin A1c (HbA1c)
Description
Glycosylated Haemoglobin A1c measured in blood samples after 26 weeks of treatment.
Time Frame
After 26 weeks of treatment
Secondary Outcome Measure Information:
Title
9-point Self-measured Plasma Glucose Profiles
Description
Glycaemic control measured by 9-point self-measured plasma glucose (SMPG) profiles. The 9 time points for self-measurement during the day were: Before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 AM, and before breakfast the following day. Hypoglycaemia episodes were defined as major or minor. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL.
Time Frame
After 26 weeks of treatment
Title
Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c)
Description
The number of subjects achieving the treatment target for glycosylated haemoglobin A1c after 26 weeks treatment. The treatment targets were: HbA1c <= 6.5% of haemoglobin and HbA1c < 7% of haemoglobin.
Time Frame
After 26 weeks of treatment
Title
Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat)
Description
Subjects assessed the burden, efficacy, symptoms and overall score in the treatment satisfaction questionnaire, Diab MedSat (Diabetes Medication Satisfaction questionnaire). The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale.
Time Frame
After 26 weeks of treatment
Title
Number of Hypoglycaemic Episodes
Description
Total number of hypoglycaemic episodes experienced in each treatment arm. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.
Time Frame
Weeks 0-26
Title
Number of Subjects Reporting Treatment Emergent Adverse Events
Description
Number of subjects reporting treatment emergent adverse events during the trial (from week 0 to week 26). Adverse events were reported as treatment emergent if they occurred from the date of first insulin trial product administration up to and including the date of last insulin trial product administration.
Time Frame
Weeks 0-26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes Treatment with OADs (Oral Anti-Diabetic Drugs) for more than 6 months Ongoing stable treatment with metformin for at least 2 months Ongoing stable treatment with minimum half maximal dose of any insulin secretagogue for at least 2 months Insulin naive HbA1c (glycosylated haemoglobin A1c) between 7.0% and 11.0% (inclusive of both values) Exclusion Criteria: Metformin contraindication according to local practice TZD (thiazolidinedione) treatment for the last 5 months before trial start Systemic treatment with any corticosteroid 3 months before trial start Any disease or condition which according to the Investigator would interfere with the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Ciudad Autonoma de Bs As
ZIP/Postal Code
C1405CWB
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Ciudad Autónoma de BsAs
ZIP/Postal Code
C1406FWY
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Mar del Plata
ZIP/Postal Code
B7602CBM
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Bregenz
ZIP/Postal Code
A - 6900
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Feldkirch
ZIP/Postal Code
6807
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Traisen
ZIP/Postal Code
3160
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
1100
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Brno
ZIP/Postal Code
656 91
Country
Czech Republic
Facility Name
Novo Nordisk Investigational Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Novo Nordisk Investigational Site
City
Kragujevac
ZIP/Postal Code
34000
Country
Former Serbia and Montenegro
Facility Name
Novo Nordisk Investigational Site
City
Nis
ZIP/Postal Code
18000
Country
Former Serbia and Montenegro
Facility Name
Novo Nordisk Investigational Site
City
Novi Sad
ZIP/Postal Code
21000
Country
Former Serbia and Montenegro
Facility Name
Novo Nordisk Investigational Site
City
LA ROCHELLE cedex
ZIP/Postal Code
17019
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Mougins
ZIP/Postal Code
06250
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Narbonne
ZIP/Postal Code
11108
Country
France
Facility Name
Novo Nordisk Investigational Site
City
NEVERS cedex
ZIP/Postal Code
58033
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Pointe à Pitre
ZIP/Postal Code
97159
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Karnal
State/Province
Haryana
ZIP/Postal Code
132001
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560043
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Visakhapatnam
ZIP/Postal Code
530001
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Cheras
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Kota Bharu, Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Guadalajara
ZIP/Postal Code
44600
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Guadalajara
ZIP/Postal Code
44620
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Pachuca
ZIP/Postal Code
42060
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Almere
ZIP/Postal Code
1311RL
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Groningen
ZIP/Postal Code
9711 SG
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Leiderdorp
ZIP/Postal Code
2352 RA
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Rotterdam
ZIP/Postal Code
3021 HC
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Zoetermeer
ZIP/Postal Code
2724 EK
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Manila
ZIP/Postal Code
1014
Country
Philippines
Facility Name
Novo Nordisk Investigational Site
City
Quezon City
ZIP/Postal Code
1100
Country
Philippines
Facility Name
Novo Nordisk Investigational Site
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
Facility Name
Novo Nordisk Investigational Site
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Gdansk
ZIP/Postal Code
80-858
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Gdynia
ZIP/Postal Code
81-366
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lubin
ZIP/Postal Code
59-301
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Poznan
ZIP/Postal Code
60-821
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Rzeszow
ZIP/Postal Code
35-301
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Szczecin
ZIP/Postal Code
71-455
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Botosani
ZIP/Postal Code
710224
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Bucharest
ZIP/Postal Code
020475
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Galati
ZIP/Postal Code
800371
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Satu Mare
ZIP/Postal Code
440055
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Targoviste
ZIP/Postal Code
130083
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Brits
State/Province
North West
ZIP/Postal Code
0250
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Alzira
ZIP/Postal Code
46600
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Málaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
19821654
Citation
Strojek K, Bebakar WM, Khutsoane DT, Pesic M, Smahelova A, Thomsen HF, Kalra S. Once-daily initiation with biphasic insulin aspart 30 versus insulin glargine in patients with type 2 diabetes inadequately controlled with oral drugs: an open-label, multinational RCT. Curr Med Res Opin. 2009 Dec;25(12):2887-94. doi: 10.1185/03007990903354674.
Results Reference
result
PubMed Identifier
20363044
Citation
Kalra S, Plata-Que T, Kumar D, Mumtaz M, Sondergaard F, Kozlovski P, Bebakar WM. Initiation with once-daily BIAsp 30 results in superior outcome compared to insulin glargine in Asians with type 2 diabetes inadequately controlled by oral anti-diabetic drugs. Diabetes Res Clin Pract. 2010 Jun;88(3):282-8. doi: 10.1016/j.diabres.2010.03.004. Epub 2010 Apr 2.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes

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