To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together (LEAD-2)

January 24, 2017 updated by: Novo Nordisk A/S

Liraglutide Effect and Action in Diabetes (LEAD-2): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Metformin Versus Metformin Monotherapy Versus Metformin and Glimepiride Combination Therapy in Subjects With Type 2 Diabetes

This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1091

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

  • Argentina
      • Ciudad Autonoma de Bs As, Argentina, C1405CWB
        • Novo Nordisk Investigational Site
      • Ciudad Autónoma de Bs As, Argentina, C1426ABP
        • Novo Nordisk Investigational Site
      • Ciudad Autónoma de BsAs, Argentina, C1406FWY
        • Novo Nordisk Investigational Site
      • Junín, Argentina, 6000
        • Novo Nordisk Investigational Site
  • Australia
      • Adelaide, Australia, 5000
        • Novo Nordisk Investigational Site
      • Adelaide, Australia, SA 5035
        • Novo Nordisk Investigational Site
      • Auckland, Australia
        • Novo Nordisk Investigational Site
      • Bankstown, Australia, 2200
        • Novo Nordisk Investigational Site
      • Box Hill, Australia, 3128
        • Novo Nordisk Investigational Site
      • Cairns, Australia, 4870
        • Novo Nordisk Investigational Site
      • Camperdown, Australia, 2050
        • Novo Nordisk Investigational Site
      • Christchurch, Australia, 8011
        • Novo Nordisk Investigational Site
      • Clayton, Australia, 3168
        • Novo Nordisk Investigational Site
      • Fitzroy, Australia, 3065
        • Novo Nordisk Investigational Site
      • Garran, Australia, 2605
        • Novo Nordisk Investigational Site
      • Hornsby, Australia, 2077
        • Novo Nordisk Investigational Site
      • Malvern, Australia, 3144
        • Novo Nordisk Investigational Site
      • Perth, Australia, 6000
        • Novo Nordisk Investigational Site
      • Westmead, Australia, 2145
        • Novo Nordisk Investigational Site
      • Woodville, Australia, 5011
        • Novo Nordisk Investigational Site
    • New South Wales
      • Broadmeadow, New South Wales, Australia, 2292
        • Novo Nordisk Investigational Site
      • Penrith, New South Wales, Australia, 2751
        • Novo Nordisk Investigational Site
      • St Leonards, New South Wales, Australia, 2065
        • Novo Nordisk Investigational Site
    • South Australia
      • Daw Park, South Australia, Australia, 5041
        • Novo Nordisk Investigational Site
    • Victoria
      • East Ringwood, Victoria, Australia, 3135
        • Novo Nordisk Investigational Site
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Novo Nordisk Investigational Site
  • Belgium
      • Arlon, Belgium, 6700
        • Novo Nordisk Investigational Site
      • Bonheiden, Belgium, 2820
        • Novo Nordisk Investigational Site
      • Gent, Belgium, 9000
        • Novo Nordisk Investigational Site
      • Huy, Belgium, 4500
        • Novo Nordisk Investigational Site
      • La Louvière, Belgium, 7100
        • Novo Nordisk Investigational Site
      • Leuven, Belgium, 3000
        • Novo Nordisk Investigational Site
  • Bulgaria
      • Sofia, Bulgaria, 1431
        • Novo Nordisk Investigational Site
  • Croatia
      • Zagreb, Croatia, 10 000
        • Novo Nordisk Investigational Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Novo Nordisk Investigational Site
      • Frederiksberg, Denmark, 2000
        • Novo Nordisk Investigational Site
      • Herlev, Denmark, 2730
        • Novo Nordisk Investigational Site
      • Hjørring, Denmark, 9800
        • Novo Nordisk Investigational Site
      • Hvidovre, Denmark, 2650
        • Novo Nordisk Investigational Site
      • København, Denmark, 2400
        • Novo Nordisk Investigational Site
      • København S, Denmark, 2300
        • Novo Nordisk Investigational Site
      • Odense, Denmark, 5000
        • Novo Nordisk Investigational Site
      • Viborg, Denmark
        • Novo Nordisk Investigational Site
      • Århus C, Denmark, 8000
        • Novo Nordisk Investigational Site
  • Germany
      • Aschaffenburg, Germany, 63739
        • 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 Mergentheim, Germany, 97980
        • Novo Nordisk Investigational Site
      • Bad Neuenahr-Ahrweiler, Germany, 53474
        • Novo Nordisk Investigational Site
      • Beckum, Germany, 59269
        • Novo Nordisk Investigational Site
      • Bensheim, Germany, 64625
        • Novo Nordisk Investigational Site
      • Berlin, Germany, 12203
        • Novo Nordisk Investigational Site
      • Berlin, Germany, 12687
        • Novo Nordisk Investigational Site
      • Berlin, Germany, 10115
        • Novo Nordisk Investigational Site
      • Darmstadt, Germany, 64283
        • Novo Nordisk Investigational Site
      • Diez, Germany, 65582
        • Novo Nordisk Investigational Site
      • Dormagen, Germany, 41539
        • Novo Nordisk Investigational Site
      • Dresden, Germany, 01219
        • Novo Nordisk Investigational Site
      • Dresden, Germany, 01307
        • Novo Nordisk Investigational Site
      • Flensburg, Germany, 24939
        • Novo Nordisk Investigational Site
      • Großheirath, Germany, 96269
        • Novo Nordisk Investigational Site
      • Halle, Germany, 06114
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 22607
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 21073
        • Novo Nordisk Investigational Site
      • Kutenholz-Mulsum, Germany, 27449
        • Novo Nordisk Investigational Site
      • Köln, Germany, 50858
        • Novo Nordisk Investigational Site
      • Ludwigshafen, Germany, 67059
        • Novo Nordisk Investigational Site
      • Marburg, Germany, 35037
        • Novo Nordisk Investigational Site
      • Münster, Germany, 48145
        • Novo Nordisk Investigational Site
      • Neuwied, Germany, 56564
        • Novo Nordisk Investigational Site
      • Oberhausen, Germany, 46145
        • Novo Nordisk Investigational Site
      • Pirna, Germany, 01796
        • Novo Nordisk Investigational Site
      • Pohlheim, Germany, 35415
        • 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
      • 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
      • Tübingen, Germany, 72072
        • Novo Nordisk Investigational Site
      • Viersen, Germany, 41751
        • Novo Nordisk Investigational Site
      • Völklingen, Germany, 66333
        • Novo Nordisk Investigational Site
      • Würzburg, Germany, 97072
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, 1041
        • Novo Nordisk Investigational Site
      • Debrecen, Hungary, 4043
        • Novo Nordisk Investigational Site
      • Gyula, Hungary, 5700
        • Novo Nordisk Investigational Site
      • Nyíregyháza, Hungary, 4400
        • Novo Nordisk Investigational Site
      • Pecs, Hungary, 7631
        • Novo Nordisk Investigational Site
      • Szekszárd, Hungary, 7100
        • Novo Nordisk Investigational Site
      • Zalaegerszeg, Hungary, 8900
        • Novo Nordisk Investigational Site
  • India
      • Bangalore, India, 560034
        • Novo Nordisk Investigational Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500082
        • Novo Nordisk Investigational Site
    • Kerala
      • Kochi, Kerala, India, 682041
        • Novo Nordisk Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Novo Nordisk Investigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600086
        • Novo Nordisk Investigational Site
  • Ireland
      • Dublin, Ireland, DUBLIN 15
        • Novo Nordisk Investigational Site
      • Dublin, Ireland, DUBLIN 7
        • Novo Nordisk Investigational Site
      • Dublin, Ireland, DUBLIN 8
        • Novo Nordisk Investigational Site
      • Waterford, Ireland
        • Novo Nordisk Investigational Site
  • Italy
      • Bari, Italy, 70124
        • Novo Nordisk Investigational Site
      • Catania, Italy, 95126
        • Novo Nordisk Investigational Site
      • Firenze, Italy, 50141
        • Novo Nordisk Investigational Site
      • Milano, Italy, 20122
        • Novo Nordisk Investigational Site
      • Milano, Italy, 20132
        • Novo Nordisk Investigational Site
      • Monza, Italy, 20052
        • Novo Nordisk Investigational Site
      • Orbassano, Italy, 10043
        • Novo Nordisk Investigational Site
      • Padova, Italy, 35128
        • Novo Nordisk Investigational Site
      • Palermo, Italy, 90127
        • Novo Nordisk Investigational Site
      • Rimini, Italy, 47900
        • Novo Nordisk Investigational Site
      • Roma, Italy, 00161
        • Novo Nordisk Investigational Site
      • Sassari, Italy, 07100
        • Novo Nordisk Investigational Site
      • Torino, Italy, 10154
        • Novo Nordisk Investigational Site
      • Verona, Italy, 37126
        • Novo Nordisk Investigational Site
  • Netherlands
      • Apeldoorn, Netherlands, 7334 DZ
        • Novo Nordisk Investigational Site
      • Groningen, Netherlands, 9728 NT
        • Novo Nordisk Investigational Site
      • Rotterdam, Netherlands, 3045 PM
        • Novo Nordisk Investigational Site
      • Sliedrecht, Netherlands, 3361 XV
        • Novo Nordisk Investigational Site
  • Norway
      • Bekkestua, Norway, 1357
        • Novo Nordisk Investigational Site
      • Bergen, Norway, NO-5012
        • Novo Nordisk Investigational Site
      • Elverum, Norway, 2408
        • Novo Nordisk Investigational Site
      • Gjøvik, Norway, NO-2819
        • Novo Nordisk Investigational Site
      • Hamar, Norway, 2317
        • Novo Nordisk Investigational Site
      • Kongsberg, Norway, NO-3602
        • Novo Nordisk Investigational Site
      • Kongsvinger, Norway, 2212
        • Novo Nordisk Investigational Site
      • Stavanger, Norway, 4011
        • Novo Nordisk Investigational Site
      • Tromsø, Norway, 9038
        • Novo Nordisk Investigational Site
      • Trondheim, Norway, NO-7030
        • Novo Nordisk Investigational Site
  • Romania
      • Constanta, Romania, 900591
        • Novo Nordisk Investigational Site
      • Iasi, Romania, 700111
        • Novo Nordisk Investigational Site
    • Cluj
      • Cluj Napoca, Cluj, Romania, 400006
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 119435
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 117036
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 127486
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 129090
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 194354
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 198013
        • Novo Nordisk Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 833 05
        • Novo Nordisk Investigational Site
      • Bratislava, Slovakia, 831 01
        • Novo Nordisk Investigational Site
      • Bratislava, Slovakia, 83 299
        • Novo Nordisk Investigational Site
      • Kosice, Slovakia, 04-001
        • Novo Nordisk Investigational Site
      • Moldava nad Bodvou, Slovakia, 045 01
        • Novo Nordisk Investigational Site
      • Presov, Slovakia, 080 01
        • Novo Nordisk Investigational Site
      • Trencin, Slovakia, 91 101
        • Novo Nordisk Investigational Site
  • South Africa
      • Benoni, South Africa, 1500
        • Novo Nordisk Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1829
        • Novo Nordisk Investigational Site
      • Johannesburg, Gauteng, South Africa, 27 11
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4001
        • Novo Nordisk Investigational Site
      • Durban, KwaZulu-Natal, South Africa, 4091
        • Novo Nordisk Investigational Site
      • Durban, KwaZulu-Natal, South Africa, 4092
        • Novo Nordisk Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7130
        • Novo Nordisk Investigational Site
  • Spain
      • Alcazar de San Juan, Spain, 13600
        • Novo Nordisk Investigational Site
      • Almería, Spain, 04001
        • Novo Nordisk Investigational Site
      • Barcelona, Spain, 08017
        • Novo Nordisk Investigational Site
      • Bilbao, Spain, 48013
        • Novo Nordisk Investigational Site
      • Cádiz, Spain, 11009
        • Novo Nordisk Investigational Site
      • Girona, Spain, 17007
        • Novo Nordisk Investigational Site
      • Granada, Spain, 18012
        • Novo Nordisk Investigational Site
      • La Coruña, Spain, 15006
        • Novo Nordisk Investigational Site
      • La Laguna, Spain, 38320
        • Novo Nordisk Investigational Site
      • Málaga, Spain, 29010
        • Novo Nordisk Investigational Site
      • Mérida, Spain, 06800
        • Novo Nordisk Investigational Site
      • San Juan, Spain, 03550
        • Novo Nordisk Investigational Site
      • Santa Cruz de Tenerife, Spain, 38010
        • Novo Nordisk Investigational Site
      • Santander, Spain, 39008
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41009
        • Novo Nordisk Investigational Site
  • Sweden
      • Falun, Sweden, 791 82
        • Novo Nordisk Investigational Site
      • Karlstad, Sweden, 651 85
        • Novo Nordisk Investigational Site
      • Linköping, Sweden, 581 85
        • Novo Nordisk Investigational Site
      • Lund, Sweden, 221 85
        • Novo Nordisk Investigational Site
      • Malmö, Sweden, 205 02
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 171 76
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 118 83
        • Novo Nordisk Investigational Site
      • Umeå, Sweden, 901 85
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Abergavenny, United Kingdom, NP7 7EG
        • Novo Nordisk Investigational Site
      • Bath, United Kingdom, BA2 1NH
        • Novo Nordisk Investigational Site
      • Bath, United Kingdom, BA1 2SR
        • Novo Nordisk Investigational Site
      • Berkshire, United Kingdom, RG7 3SQ
        • Novo Nordisk Investigational Site
      • Cardiff, United Kingdom, CF23 8SQ
        • Novo Nordisk Investigational Site
      • Coventry, United Kingdom, CV2 2DX
        • Novo Nordisk Investigational Site
      • Dundee, United Kingdom, DD1 9SY
        • Novo Nordisk Investigational Site
      • East Horsley, United Kingdom, KT24 6QT
        • Novo Nordisk Investigational Site
      • Frome, United Kingdom, BA11 1EZ
        • Novo Nordisk Investigational Site
      • Llanelli, United Kingdom, SA14 8QF
        • Novo Nordisk Investigational Site
      • Oxford, United Kingdom, OX3 7LE
        • Novo Nordisk Investigational Site
      • Plymouth, United Kingdom, PL6 8BQ
        • Novo Nordisk Investigational Site
      • Sheffield, United Kingdom, S3 9DA
        • Novo Nordisk Investigational Site
      • Sunbury on Thames, United Kingdom, TW16 6RH
        • 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 to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects diagnosed with type 2 diabetes and treated with oral anti-diabetic drugs (OADs) for at least 3 months
  • HbA1c: 7.0-11.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy
  • Body Mass Index (BMI) less than or equal 40 kg/m2

Exclusion Criteria:

  • Subjects treated with insulin within the last three months
  • Subjects with any serious medical condition
  • Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods
  • Subjects using any drug (except for OADs), which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lira 0.6 + Met
Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
Drug: liraglutide
0.6 mg for s.c. (under the skin) injection.
Drug: metformin
1.5-2.0 g tablets
Drug: placebo
Glimepiride placebo 1 mg and 2 mg tablets
Drug: placebo
Liraglutide placebo 1-3 mL for s.c. (under the skin) injection
Drug: liraglutide
1.2 mg for s.c. (under the skin) injection
Drug: liraglutide
1.8 mg for s.c. (under the skin) injection
EXPERIMENTAL: Lira 1.2 + Met
Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
Drug: liraglutide
0.6 mg for s.c. (under the skin) injection.
Drug: metformin
1.5-2.0 g tablets
Drug: placebo
Glimepiride placebo 1 mg and 2 mg tablets
Drug: placebo
Liraglutide placebo 1-3 mL for s.c. (under the skin) injection
Drug: liraglutide
1.2 mg for s.c. (under the skin) injection
Drug: liraglutide
1.8 mg for s.c. (under the skin) injection
EXPERIMENTAL: Lira 1.8 + Met
Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
Drug: liraglutide
0.6 mg for s.c. (under the skin) injection.
Drug: metformin
1.5-2.0 g tablets
Drug: placebo
Glimepiride placebo 1 mg and 2 mg tablets
Drug: placebo
Liraglutide placebo 1-3 mL for s.c. (under the skin) injection
Drug: liraglutide
1.2 mg for s.c. (under the skin) injection
Drug: liraglutide
1.8 mg for s.c. (under the skin) injection
ACTIVE_COMPARATOR: Met Mono
Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo
Drug: metformin
1.5-2.0 g tablets
Drug: placebo
Glimepiride placebo 1 mg and 2 mg tablets
Drug: placebo
Liraglutide placebo 1-3 mL for s.c. (under the skin) injection
ACTIVE_COMPARATOR: Met + Glim
Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo
Drug: metformin
1.5-2.0 g tablets
Drug: placebo
Glimepiride placebo 1 mg and 2 mg tablets
Drug: placebo
Liraglutide placebo 1-3 mL for s.c. (under the skin) injection
Drug: glimepiride
4 mg tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycosylated A1c (HbA1c) at Week 26
Time Frame: week 0, week 26
Percentage point change in Glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)
week 0, week 26
Change in Glycosylated A1c (HbA1c) at Week 104
Time Frame: week 0, week 104
Change in glycosylated A1c (HbA1c) baseline (week 0) to 104 weeks (end of randomisation)
week 0, week 104

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight at Week 26
Time Frame: week 0, week 26
Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)
week 0, week 26
Change in Body Weight at Week 104
Time Frame: week 0, week 104
Change in body weight from baseline (week 0) to 104 weeks (end of treatment)
week 0, week 104
Change in Fasting Plasma Glucose (FPG) at Week 26
Time Frame: week 0, week 26
Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation)
week 0, week 26
Change in Fasting Plasma Glucose (FPG) at Week 104
Time Frame: week 0, week 104
Change in Fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of treatment)
week 0, week 104
Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26
Time Frame: week 0, week 26

Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.

Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three.
week 0, week 26
Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104
Time Frame: week 0, week 104

Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of treatment). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.

Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three.
week 0, week 104
Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26
Time Frame: week 0, week 26
Change in mean post prandial plasma glucose from baseline (Week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three.
week 0, week 26
Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104
Time Frame: week 0, week 104
Change in mean post prandial plasma glucose from baseline (Week 0) to 104 weeks (end of treatment) The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three.
week 0, week 104
Change in Beta-cell Function at Week 26
Time Frame: week 0, week 26

Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5).
week 0, week 26
Change in Beta-cell Function at Week 104
Time Frame: week 0, week 104

Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5).
week 0, week 104
Hypoglycaemic Episodes at Week 26
Time Frame: weeks 0-26
Total number of hypoglycaemic episodes occuring after baseline (week 0) until week 26 (end of randomisation). 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. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
weeks 0-26
Hypoglycaemic Episodes at Week 104
Time Frame: weeks 0-104
Total number of hypoglycaemic episodes occuring after baseline (week 0) until 104 weeks (end of treatment). 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. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
weeks 0-104

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.

General Publications

Helpful Links

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

May 1, 2006

Primary Completion (ACTUAL)

May 1, 2007

Study Completion (ACTUAL)

November 1, 2008

Study Registration Dates

First Submitted

April 25, 2006

First Submitted That Met QC Criteria

April 25, 2006

First Posted (ESTIMATE)

April 26, 2006

Study Record Updates

Last Update Posted (ACTUAL)

March 7, 2017

Last Update Submitted That Met QC Criteria

January 24, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-1572

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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