Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes (PreFER)

June 26, 2017 updated by: Novo Nordisk A/S

Comparison of Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus

This trial is conducted in Europe.

The aim of this trial is to investigate the efficacy and safety of an intensified treatment regimen with preprandial insulin aspart and insulin detemir once or twice daily to a more convenient regimen with biphasic insulin aspart 30 twice daily on blood glucose control in subjects with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

719

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Austria
- - Graz, Austria, 8036
    - Novo Nordisk Investigational Site
  - Linz, Austria, 4021
    - Novo Nordisk Investigational Site
  - Wien, Austria, A 1090
    - Novo Nordisk Investigational Site
  - Wien, Austria, A-1130
    - Novo Nordisk Investigational Site
  - Wien, Austria, 1230
    - Novo Nordisk Investigational Site
Germany
- - Alsdorf, Germany, 52477
    - Novo Nordisk Investigational Site
  - Altenburg, Germany, 04600
    - Novo Nordisk Investigational Site
  - Altenkirchen, Germany, 57610
    - Novo Nordisk Investigational Site
  - Altenstadt, Germany, 63674
    - Novo Nordisk Investigational Site
  - Aschaffenburg, Germany, 63739
    - Novo Nordisk Investigational Site
  - Augsburg, Germany, 86150
    - Novo Nordisk Investigational Site
  - Bad Harzburg, Germany, 38667
    - Novo Nordisk Investigational Site
  - Bad Heilbrunn, Germany, 83670
    - Novo Nordisk Investigational Site
  - Bad Kreuznach, Germany, 55545
    - Novo Nordisk Investigational Site
  - Bad Lauterberg, Germany, 37431
    - Novo Nordisk Investigational Site
  - Bad Lippspringe, Germany, 33175
    - Novo Nordisk Investigational Site
  - Bad Mergentheim, Germany, 97980
    - Novo Nordisk Investigational Site
  - Bad Neuenahr-Ahrweiler, Germany, 53474
    - Novo Nordisk Investigational Site
  - Bad Oldesloe, Germany, 23843
    - Novo Nordisk Investigational Site
  - Bad Staffelstein, Germany, 96231
    - Novo Nordisk Investigational Site
  - Bensheim, Germany, 64625
    - Novo Nordisk Investigational Site
  - Berlin, Germany, 10789
    - Novo Nordisk Investigational Site
  - Berlin, Germany, 10318
    - Novo Nordisk Investigational Site
  - Berlin, Germany, 10559
    - Novo Nordisk Investigational Site
  - Berlin, Germany, 12203
    - Novo Nordisk Investigational Site
  - Berlin, Germany, 12687
    - Novo Nordisk Investigational Site
  - Berlin, Germany, 13055
    - Novo Nordisk Investigational Site
  - Bochum, Germany, 44791
    - Novo Nordisk Investigational Site
  - Damme, Germany, 49401
    - Novo Nordisk Investigational Site
  - Diez, Germany, 65582
    - Novo Nordisk Investigational Site
  - Dinslaken, Germany, 46537
    - Novo Nordisk Investigational Site
  - Dormagen, Germany, 41539
    - Novo Nordisk Investigational Site
  - Dortmund, Germany, 44145
    - Novo Nordisk Investigational Site
  - Dortmund, Germany, 44225
    - Novo Nordisk Investigational Site
  - Dresden, Germany, 01219
    - Novo Nordisk Investigational Site
  - Dresden, Germany, 01307
    - Novo Nordisk Investigational Site
  - Duisburg, Germany, 47051
    - Novo Nordisk Investigational Site
  - Duisburg, Germany, 47179
    - Novo Nordisk Investigational Site
  - Emmerich, Germany, 46446
    - Novo Nordisk Investigational Site
  - Essen, Germany, 45307
    - Novo Nordisk Investigational Site
  - Essen, Germany, 45329
    - Novo Nordisk Investigational Site
  - Flensburg, Germany, 24939
    - Novo Nordisk Investigational Site
  - Flörsheim, Germany, 65439
    - Novo Nordisk Investigational Site
  - Forchheim, Germany, 91301
    - Novo Nordisk Investigational Site
  - Frankfurt, Germany, 60590
    - Novo Nordisk Investigational Site
  - Frankfurt, Germany, 60325
    - Novo Nordisk Investigational Site
  - Frankfurt, Germany, 60326
    - Novo Nordisk Investigational Site
  - Frankfurt, Germany, 60433
    - Novo Nordisk Investigational Site
  - Freiburg, Germany, 79106
    - Novo Nordisk Investigational Site
  - Freital, Germany, 01705
    - Novo Nordisk Investigational Site
  - Gebhardshain, Germany, 57580
    - Novo Nordisk Investigational Site
  - Genthin, Germany, 39307
    - Novo Nordisk Investigational Site
  - Georgsmarienhütte, Germany, 49124
    - Novo Nordisk Investigational Site
  - Giessen, Germany, 35390
    - Novo Nordisk Investigational Site
  - Gotha, Germany, 99867
    - Novo Nordisk Investigational Site
  - Halle, Germany, 06114
    - Novo Nordisk Investigational Site
  - Hamburg, Germany, 20251
    - Novo Nordisk Investigational Site
  - Hamburg, Germany, 22607
    - Novo Nordisk Investigational Site
  - Hamburg, Germany, 22041
    - Novo Nordisk Investigational Site
  - Hamburg, Germany, 20097
    - Novo Nordisk Investigational Site
  - Hameln, Germany, 31785
    - Novo Nordisk Investigational Site
  - Hannover, Germany, 30167
    - Novo Nordisk Investigational Site
  - Herne, Germany, 44653
    - Novo Nordisk Investigational Site
  - Herrenberg, Germany, 71083
    - Novo Nordisk Investigational Site
  - Hildesheim, Germany, 31139
    - Novo Nordisk Investigational Site
  - Hohenmölsen, Germany, 06679
    - Novo Nordisk Investigational Site
  - Hünxe, Germany, 46569
    - Novo Nordisk Investigational Site
  - Idar-Oberstein, Germany, 55743
    - Novo Nordisk Investigational Site
  - Jena, Germany, 07743
    - Novo Nordisk Investigational Site
  - Kaiserslautern, Germany, 67675
    - Novo Nordisk Investigational Site
  - Karlsruhe, Germany, 76133
    - Novo Nordisk Investigational Site
  - Krummennaab, Germany, 92703
    - Novo Nordisk Investigational Site
  - Künzing, Germany, 94550
    - Novo Nordisk Investigational Site
  - Landau, Germany, 76829
    - Novo Nordisk Investigational Site
  - Langen, Germany, 63225
    - Novo Nordisk Investigational Site
  - Lindenfels, Germany, 64678
    - Novo Nordisk Investigational Site
  - Lübeck, Germany, 23562
    - Novo Nordisk Investigational Site
  - Mainz, Germany, 55131
    - Novo Nordisk Investigational Site
  - Marburg, Germany, 35037
    - Novo Nordisk Investigational Site
  - Marktheidenfeld, Germany, 97828
    - Novo Nordisk Investigational Site
  - Meppen, Germany, 49716
    - Novo Nordisk Investigational Site
  - Mühlheim, Germany, 63165
    - Novo Nordisk Investigational Site
  - München, Germany, 81737
    - Novo Nordisk Investigational Site
  - Neumünster, Germany, 24534
    - Novo Nordisk Investigational Site
  - Neuwied, Germany, 56564
    - Novo Nordisk Investigational Site
  - Nittenau, Germany, 93149
    - Novo Nordisk Investigational Site
  - Northeim, Germany, 37154
    - Novo Nordisk Investigational Site
  - Oberhausen, Germany, 46145
    - Novo Nordisk Investigational Site
  - Oberndorf, Germany, 78727
    - Novo Nordisk Investigational Site
  - Oberursel, Germany, 61440
    - Novo Nordisk Investigational Site
  - Offenbach, Germany, 63065
    - Novo Nordisk Investigational Site
  - Osnabrück, Germany, 49080
    - Novo Nordisk Investigational Site
  - Pforzheim, Germany, 75172
    - Novo Nordisk Investigational Site
  - Pirna, Germany, 01796
    - Novo Nordisk Investigational Site
  - Regensburg, Germany, 93059
    - Novo Nordisk Investigational Site
  - Rehlingen-Siersburg, Germany, 66780
    - Novo Nordisk Investigational Site
  - Saaldorf-Surheim, Germany, 83416
    - Novo Nordisk Investigational Site
  - Saarbrücken, Germany, 66121
    - Novo Nordisk Investigational Site
  - Sangerhausen, Germany, 06526
    - Novo Nordisk Investigational Site
  - Schaafheim, Germany, 64850
    - Novo Nordisk Investigational Site
  - Schkeuditz, Germany, 04435
    - Novo Nordisk Investigational Site
  - Schlüchtern, Germany, 36381
    - Novo Nordisk Investigational Site
  - Schwerin, Germany, 19049
    - Novo Nordisk Investigational Site
  - Schwerin, Germany, 19059
    - Novo Nordisk Investigational Site
  - Schwerte, Germany, 58239
    - Novo Nordisk Investigational Site
  - Siegen, Germany, 57072
    - Novo Nordisk Investigational Site
  - Simmern, Germany, 55469
    - Novo Nordisk Investigational Site
  - Sinsheim, Germany, 74889
    - Novo Nordisk Investigational Site
  - Speyer, Germany, 67346
    - Novo Nordisk Investigational Site
  - St. Ingbert, Germany, 66386
    - Novo Nordisk Investigational Site
  - Stuttgart, Germany, 70184
    - Novo Nordisk Investigational Site
  - Sulzbach-Rosenberg, Germany, 92237
    - Novo Nordisk Investigational Site
  - Sögel, Germany, 49751
    - Novo Nordisk Investigational Site
  - Trier, Germany, 54290
    - Novo Nordisk Investigational Site
  - Tübingen, Germany, 72072
    - Novo Nordisk Investigational Site
  - Völklingen, Germany, 66333
    - Novo Nordisk Investigational Site
  - Wallerfing, Germany, 94574
    - Novo Nordisk Investigational Site
  - Wangen, Germany, 88239
    - Novo Nordisk Investigational Site
  - Warburg, Germany, 34414
    - Novo Nordisk Investigational Site
  - Wiesbaden, Germany, 65191
    - Novo Nordisk Investigational Site
  - Wilhelmshaven, Germany, 26382
    - Novo Nordisk Investigational Site
  - Würzburg, Germany, 97072
    - Novo Nordisk Investigational Site
Switzerland
- - Basel-Bruderholz, Switzerland, 4101
    - Novo Nordisk Investigational Site
  - Genève 14, Switzerland, 1211
    - Novo Nordisk Investigational Site
  - Lugano, Switzerland, 6900
    - Novo Nordisk Investigational Site
  - St. Gallen, Switzerland, 9000
    - Novo Nordisk Investigational Site
  - Zürich, Switzerland, 8002
    - Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Type 2 diabetes
Duration of type 2 diabetes for at least 6 months since diagnosis
Current treatment with one or two oral antidiabetic drugs for at least 3 months or with one or two oral antidiabetic drugs, given for at least 3 months in combination with intermediate or long-acting insulin/insulin analogue once daily
BMI below 40 kg/m2
HbA1c between 7-12%
Able and willing to perform self-monitoring of capillary blood glucose

Exclusion Criteria:

Current antidiabetic treatment with combination of three or more oral antidiabetic drugs
Previous treatment with short-acting human insulin, short-acting insulin analogue or biphasic insulin/insulin analogue within the last 6 months (7 days or less within the last 6 months is allowed)
Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
Known or suspected allergy to trial product or related products
Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures
Receipt of any investigational drug within 4 weeks prior to this trial
Previous participation in this trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HbA1c Time Frame: after 6 months of treatment	after 6 months of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events
Incidence of hypoglycaemic episodes
Change in weight
Difference of HbA1c change between the two groups Time Frame: after 13 weeks of treatment	after 13 weeks of treatment
Fasting plasma glucose of treatment Time Frame: after 13 and 26 weeks	after 13 and 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Clinical Trials at Novo Nordisk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2003

Primary Completion (Actual)

March 3, 2005

Study Completion (Actual)