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NCT00622284 Clinical Trial

Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A Randomised Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 1356 ( 5.0 mg, Administered Orally Once Daily) Compared to Glimepiride Over Two Years in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00622284
Other study ID # 1218.20
Secondary ID 2007-004585-40
Status Completed
Phase Phase 3
First received February 13, 2008
Last updated December 11, 2013
Start date February 2008

Study information
Verified date December 2013
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Bulgaria: Bulgarian Drug Agency, BG-1504 SofiaDenmark: Danish Medicines AgencyFrance: AFSSAPS 143/147, bld Anatole France 93285 Saint-Denis Cedex FRANCEGermany: Federal Institute for Drugs and Medical DevicesGreat Britain: MHRAHong Kong: Department of HealthHungary: National Institute of Pharmacy, H-1051 BudapestIndia: Drugs Controller General of IndiaIreland: Irish Medicines BoardItaly: Comitato Etico Locale per la Sperimentazione Clinica dei Medicinali A.O. Universitaria Senese - Località Le Scotte - SIENANetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Norway: Norwegian Medicines Agency (Statens Legemiddelverk)Poland: Registration Medicinal Product Medical Device Biocidal ProductSouth Africa: Medicines Control CouncilSweden: Sweden; Läkemedelsverket (Medical Product Agency)United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably > 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control

Recruitment information / eligibility
Status Completed
Enrollment 1560
Est. completion date
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion criteria:

1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug

2. Glycosylated haemoglobin (HbA1c) 6.0 - 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug

3. HbA1c 6.5 - 10.0% at screening for patients treated with metformin alone

4. HbA1c 6.5 - 10.0% at beginning of the placebo run-in phase

Exclusion criteria:

1. Myocardial infarction, stroke or transient ischemic attack (TIA)

2. Impaired hepatic function

3. Renal failure or renal impairment

4. Treatment with rosiglitazone or pioglitazone within 6 months prior to screening

5. Treatment with insulin or glucagon-like peptide 1 (GLP-1) analogue/antagonists within 3 months prior to screening

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo identical to BI 1356 5mg
Placebo tablet once daily
• Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg
Placebo tablets once daily
• BI 1356
5mg, once daily in the morning for 104 weeks
• Glimepiride
1mg or 2mg or 3mg or 4mg in the morning for 104 weeks

Locations
Country Name City State
Bulgaria 1218.20.35201 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1218.20.35202 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1218.20.35203 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1218.20.35207 Boehringer Ingelheim Investigational Site Sofia
Bulgaria 1218.20.35204 Boehringer Ingelheim Investigational Site Stara Zagora
Denmark 1218.20.45006 Boehringer Ingelheim Investigational Site Aalborg
Denmark 1218.20.45001 Boehringer Ingelheim Investigational Site Aarhus C
Denmark 1218.20.45011 Boehringer Ingelheim Investigational Site Aarhus C
Denmark 1218.20.45013 Boehringer Ingelheim Investigational Site Aarhus C
Denmark 1218.20.45002 Boehringer Ingelheim Investigational Site Hvidovre
Denmark 1218.20.45003 Boehringer Ingelheim Investigational Site København NV
Denmark 1218.20.45007 Boehringer Ingelheim Investigational Site Odense
France 1218.20.3308A Boehringer Ingelheim Investigational Site Joué les Tours
France 1218.20.3308C Boehringer Ingelheim Investigational Site Joué les Tours
France 1218.20.3308D Boehringer Ingelheim Investigational Site Joué les Tours
France 1218.20.3308E Boehringer Ingelheim Investigational Site Joué les Tours
France 1218.20.3308F Boehringer Ingelheim Investigational Site Joué les Tours
France 1218.20.3309A Boehringer Ingelheim Investigational Site Joué les Tours
France 1218.20.3309B Boehringer Ingelheim Investigational Site Joué les Tours
France 1218.20.3309C Boehringer Ingelheim Investigational Site Joué les Tours
France 1218.20.3309D Boehringer Ingelheim Investigational Site Joué les Tours
France 1218.20.3309E Boehringer Ingelheim Investigational Site Joué les Tours
France 1218.20.3311A Boehringer Ingelheim Investigational Site Joué les Tours
France 1218.20.3311B Boehringer Ingelheim Investigational Site Joué les Tours
France 1218.20.3311C Boehringer Ingelheim Investigational Site Joué les Tours
France 1218.20.3313A Boehringer Ingelheim Investigational Site Joué les Tours
France 1218.20.3313B Boehringer Ingelheim Investigational Site Joué les Tours
France 1218.20.3313C Boehringer Ingelheim Investigational Site Joué les Tours
France 1218.20.3313D Boehringer Ingelheim Investigational Site Joué les Tours
France 1218.20.3314A Boehringer Ingelheim Investigational Site Joué les Tours
France 1218.20.3314B Boehringer Ingelheim Investigational Site Joué les Tours
France 1218.20.3314C Boehringer Ingelheim Investigational Site Joué les Tours
France 1218.20.3314D Boehringer Ingelheim Investigational Site Joué les Tours
France 1218.20.3314E Boehringer Ingelheim Investigational Site Joué les Tours
France 1218.20.3314F Boehringer Ingelheim Investigational Site Joué les Tours
France 1218.20.3307A Boehringer Ingelheim Investigational Site Joué les Tours Cedex
France 1218.20.3307B Boehringer Ingelheim Investigational Site Joué les Tours cedex
France 1218.20.3307C Boehringer Ingelheim Investigational Site Joué les Tours cedex
France 1218.20.3307D Boehringer Ingelheim Investigational Site Joué les Tours cedex
France 1218.20.3307E Boehringer Ingelheim Investigational Site Joué les Tours cedex
France 1218.20.3307F Boehringer Ingelheim Investigational Site Joué les Tours cedex
France 1218.20.3307G Boehringer Ingelheim Investigational Site Joué les Tours cedex
France 1218.20.3307H Boehringer Ingelheim Investigational Site Joué les Tours cedex
France 1218.20.3307I Boehringer Ingelheim Investigational Site Joué les Tours cedex
France 1218.20.3310A Boehringer Ingelheim Investigational Site Joué les Tours Cedex
France 1218.20.3310B Boehringer Ingelheim Investigational Site Joué les Tours Cedex
France 1218.20.3310C Boehringer Ingelheim Investigational Site Joué les Tours Cedex
France 1218.20.3310D Boehringer Ingelheim Investigational Site Joué les Tours Cedex
France 1218.20.3310E Boehringer Ingelheim Investigational Site Joué les Tours Cedex
France 1218.20.3312A Boehringer Ingelheim Investigational Site Joué les Tours Cedex
France 1218.20.3312B Boehringer Ingelheim Investigational Site Joué les Tours Cedex
France 1218.20.3312C Boehringer Ingelheim Investigational Site Joué les Tours Cedex
France 1218.20.3312D Boehringer Ingelheim Investigational Site Joué les Tours Cedex
France 1218.20.3302A Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3302C Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3302D Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3302E Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3302G Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3302H Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3302I Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3303A Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3303B Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3303C Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3303D Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3303E Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3303G Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3303H Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3303I Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3304A Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3304B Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3304C Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3304D Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3304F Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3304H Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3305A Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3305B Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3305H Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3306A Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3306B Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3306D Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3306F Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3306G Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3306H Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3306I Boehringer Ingelheim Investigational Site Nantes
France 1218.20.3301A Boehringer Ingelheim Investigational Site Nantes Cedex 1
France 1218.20.3311D Boehringer Ingelheim Investigational Site Potigny
Germany 1218.20.49004 Boehringer Ingelheim Investigational Site Aschaffenburg
Germany 1218.20.49028 Boehringer Ingelheim Investigational Site Bad Mergentheim
Germany 1218.20.49022 Boehringer Ingelheim Investigational Site Berlin
Germany 1218.20.49024 Boehringer Ingelheim Investigational Site Bosenheim
Germany 1218.20.49020 Boehringer Ingelheim Investigational Site Dresden
Germany 1218.20.49018 Boehringer Ingelheim Investigational Site Flörsheim
Germany 1218.20.49015 Boehringer Ingelheim Investigational Site Frankfurt/Main
Germany 1218.20.49006 Boehringer Ingelheim Investigational Site Großheirath
Germany 1218.20.49025 Boehringer Ingelheim Investigational Site Haag
Germany 1218.20.49016 Boehringer Ingelheim Investigational Site Hamburg
Germany 1218.20.49029 Boehringer Ingelheim Investigational Site Hannover
Germany 1218.20.49021 Boehringer Ingelheim Investigational Site Hatten
Germany 1218.20.49017 Boehringer Ingelheim Investigational Site Kelkheim
Germany 1218.20.49012 Boehringer Ingelheim Investigational Site Köln
Germany 1218.20.49005 Boehringer Ingelheim Investigational Site Künzing
Germany 1218.20.49010 Boehringer Ingelheim Investigational Site Leipzig
Germany 1218.20.49003 Boehringer Ingelheim Investigational Site Neuwied
Germany 1218.20.49007 Boehringer Ingelheim Investigational Site Nürnberg
Germany 1218.20.49008 Boehringer Ingelheim Investigational Site Rednitzhembach
Germany 1218.20.49027 Boehringer Ingelheim Investigational Site Saaldorf-Surheim
Germany 1218.20.49014 Boehringer Ingelheim Investigational Site Saarbrücken
Germany 1218.20.49030 Boehringer Ingelheim Investigational Site Speyer
Germany 1218.20.49019 Boehringer Ingelheim Investigational Site St. Ingbert/Oberwürzbach
Germany 1218.20.49002 Boehringer Ingelheim Investigational Site Sulzbach-Rosenberg
Germany 1218.20.49009 Boehringer Ingelheim Investigational Site Unterschneidheim
Germany 1218.20.49026 Boehringer Ingelheim Investigational Site Wangen
Germany 1218.20.49011 Boehringer Ingelheim Investigational Site Westerkappeln
Germany 1218.20.49013 Boehringer Ingelheim Investigational Site Würzburg
Hong Kong 1218.20.85201 Boehringer Ingelheim Investigational Site Hong Kong
Hong Kong 1218.20.85202 Boehringer Ingelheim Investigational Site Hong Kong
Hong Kong 1218.20.85204 Boehringer Ingelheim Investigational Site Hong Kong
Hungary 1218.20.36208 Boehringer Ingelheim Investigational Site Ajka
Hungary 1218.20.36205 Boehringer Ingelheim Investigational Site Baja
Hungary 1218.20.36204 Boehringer Ingelheim Investigational Site Békéscsaba
Hungary 1218.20.36206 Boehringer Ingelheim Investigational Site Hódmezövásárhely
Hungary 1218.20.36202 Boehringer Ingelheim Investigational Site Makó
Hungary 1218.20.36201 Boehringer Ingelheim Investigational Site Miskolc
Hungary 1218.20.36207 Boehringer Ingelheim Investigational Site Mosonmagyarovar
Hungary 1218.20.36203 Boehringer Ingelheim Investigational Site Szentes
India 1218.20.91022 Boehringer Ingelheim Investigational Site Chennai
India 1218.20.91024 Boehringer Ingelheim Investigational Site Coimbatore
India 1218.20.91025 Boehringer Ingelheim Investigational Site Gujarat
India 1218.20.91023 Boehringer Ingelheim Investigational Site Hyderabad
India 1218.20.91021 Boehringer Ingelheim Investigational Site Kochi
India 1218.20.91020 Boehringer Ingelheim Investigational Site Mumbai
India 1218.20.91027 Boehringer Ingelheim Investigational Site Patna
India 1218.20.91026 Boehringer Ingelheim Investigational Site Tamilnadu
Ireland 1218.20.35307 Boehringer Ingelheim Investigational Site Co. Cork
Ireland 1218.20.35304 Boehringer Ingelheim Investigational Site Co. Wexford
Ireland 1218.20.35306 Boehringer Ingelheim Investigational Site Co. Wexford
Ireland 1218.20.35310 Boehringer Ingelheim Investigational Site Co. Wexford
Ireland 1218.20.35308 Boehringer Ingelheim Investigational Site Dublin
Ireland 1218.20.35303 Boehringer Ingelheim Investigational Site Waterford
Italy 1218.20.39034 Boehringer Ingelheim Investigational Site Catania
Italy 1218.20.39027 Boehringer Ingelheim Investigational Site Chieti
Italy 1218.20.39029 Boehringer Ingelheim Investigational Site Codogno (lo)
Italy 1218.20.39021 Boehringer Ingelheim Investigational Site Genova
Italy 1218.20.39033 Boehringer Ingelheim Investigational Site Perugia
Italy 1218.20.39022 Boehringer Ingelheim Investigational Site Pordenone
Italy 1218.20.39028 Boehringer Ingelheim Investigational Site Ravenna
Italy 1218.20.39030 Boehringer Ingelheim Investigational Site Roma
Italy 1218.20.39032 Boehringer Ingelheim Investigational Site Roma
Italy 1218.20.39020 Boehringer Ingelheim Investigational Site Siena
Netherlands 1218.20.31023 Boehringer Ingelheim Investigational Site 's Hertogenbosch
Netherlands 1218.20.31014 Boehringer Ingelheim Investigational Site Almere
Netherlands 1218.20.31016 Boehringer Ingelheim Investigational Site Beek en Donk
Netherlands 1218.20.31011 Boehringer Ingelheim Investigational Site Ewijk
Netherlands 1218.20.31018 Boehringer Ingelheim Investigational Site Hoogwoud
Netherlands 1218.20.31012 Boehringer Ingelheim Investigational Site Oude Pekela
Netherlands 1218.20.31022 Boehringer Ingelheim Investigational Site Rilland
Netherlands 1218.20.31019 Boehringer Ingelheim Investigational Site Roelofarendsveen
Netherlands 1218.20.31013 Boehringer Ingelheim Investigational Site Wildervank
Norway 1218.20.47005 Boehringer Ingelheim Investigational Site Fevik
Norway 1218.20.47004 Boehringer Ingelheim Investigational Site Fornebu
Norway 1218.20.47002 Boehringer Ingelheim Investigational Site Hamar
Norway 1218.20.47001 Boehringer Ingelheim Investigational Site RUD
Norway 1218.20.47003 Boehringer Ingelheim Investigational Site Sandvika
Poland 1218.20.48210 Boehringer Ingelheim Investigational Site Bialystok
Poland 1218.20.48208 Boehringer Ingelheim Investigational Site Gdynia
Poland 1218.20.48207 Boehringer Ingelheim Investigational Site Krakow
Poland 1218.20.48201 Boehringer Ingelheim Investigational Site Lodz
Poland 1218.20.48202 Boehringer Ingelheim Investigational Site Lodz
Poland 1218.20.48203 Boehringer Ingelheim Investigational Site Olsztyn
Poland 1218.20.48206 Boehringer Ingelheim Investigational Site Torun
Poland 1218.20.48205 Boehringer Ingelheim Investigational Site Warsaw
Poland 1218.20.48209 Boehringer Ingelheim Investigational Site Warsaw
South Africa 1218.20.27007 Boehringer Ingelheim Investigational Site Bellville
South Africa 1218.20.27002 Boehringer Ingelheim Investigational Site Cape Town
South Africa 1218.20.27006 Boehringer Ingelheim Investigational Site Durban
South Africa 1218.20.27004 Boehringer Ingelheim Investigational Site Lenasia
South Africa 1218.20.27005 Boehringer Ingelheim Investigational Site Lenasia
South Africa 1218.20.27003 Boehringer Ingelheim Investigational Site Pretoria
Sweden 1218.20.46003 Boehringer Ingelheim Investigational Site Göteborg
Sweden 1218.20.46001 Boehringer Ingelheim Investigational Site Malmö
Sweden 1218.20.46002 Boehringer Ingelheim Investigational Site Malmö
Sweden 1218.20.46004 Boehringer Ingelheim Investigational Site Uppsala
United Kingdom 1218.20.44108 Boehringer Ingelheim Investigational Site Baillieston, Glasgow
United Kingdom 1218.20.44115 Boehringer Ingelheim Investigational Site Blackpool
United Kingdom 1218.20.44110 Boehringer Ingelheim Investigational Site Bradford on Avon
United Kingdom 1218.20.44102 Boehringer Ingelheim Investigational Site Buckshaw Village, Chorley
United Kingdom 1218.20.44114 Boehringer Ingelheim Investigational Site Cheadle
United Kingdom 1218.20.44116 Boehringer Ingelheim Investigational Site Chestfield, Whitstable
United Kingdom 1218.20.44109 Boehringer Ingelheim Investigational Site Chippenham
United Kingdom 1218.20.44113 Boehringer Ingelheim Investigational Site Dundee
United Kingdom 1218.20.44105 Boehringer Ingelheim Investigational Site Edgbaston, Birmingham
United Kingdom 1218.20.44112 Boehringer Ingelheim Investigational Site Ely
United Kingdom 1218.20.44101 Boehringer Ingelheim Investigational Site Guildford
United Kingdom 1218.20.44103 Boehringer Ingelheim Investigational Site Manchester
United Kingdom 1218.20.44106 Boehringer Ingelheim Investigational Site Trowbridge
United Kingdom 1218.20.44104 Boehringer Ingelheim Investigational Site Waterloo, Liverpool
United Kingdom 1218.20.44111 Boehringer Ingelheim Investigational Site Westbury
United Kingdom 1218.20.44107 Boehringer Ingelheim Investigational Site Whitstable
United States 1218.20.10003 Boehringer Ingelheim Investigational Site Chula Vista California
United States 1218.20.10032 Boehringer Ingelheim Investigational Site Cincinnati Ohio
United States 1218.20.10031 Boehringer Ingelheim Investigational Site Columbus Ohio
United States 1218.20.10022 Boehringer Ingelheim Investigational Site Endwell New York
United States 1218.20.10009 Boehringer Ingelheim Investigational Site Federal Way Washington
United States 1218.20.10002 Boehringer Ingelheim Investigational Site Greer South Carolina
United States 1218.20.10023 Boehringer Ingelheim Investigational Site Indianapolis Indiana
United States 1218.20.10020 Boehringer Ingelheim Investigational Site Los Angeles California
United States 1218.20.10035 Boehringer Ingelheim Investigational Site Los Angeles California
United States 1218.20.10037 Boehringer Ingelheim Investigational Site Los Gatos California
United States 1218.20.10013 Boehringer Ingelheim Investigational Site Mentor Ohio
United States 1218.20.10036 Boehringer Ingelheim Investigational Site Murray Utah
United States 1218.20.10042 Boehringer Ingelheim Investigational Site Oklahoma City Oklahoma
United States 1218.20.10006 Boehringer Ingelheim Investigational Site Omaha Nebraska
United States 1218.20.10045 Boehringer Ingelheim Investigational Site Perrysburg Ohio
United States 1218.20.10024 Boehringer Ingelheim Investigational Site Philadelphia Pennsylvania
United States 1218.20.10026 Boehringer Ingelheim Investigational Site Renton Washington
United States 1218.20.10029 Boehringer Ingelheim Investigational Site Salt Lake City Utah
United States 1218.20.10007 Boehringer Ingelheim Investigational Site San Antonio Texas
United States 1218.20.10028 Boehringer Ingelheim Investigational Site St. Louis Missouri
United States 1218.20.10033 Boehringer Ingelheim Investigational Site Tempe Arizona
United States 1218.20.10030 Boehringer Ingelheim Investigational Site Topeka Kansas
United States 1218.20.10034 Boehringer Ingelheim Investigational Site West Palm Beach Florida

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Bulgaria,  Denmark,  France,  Germany,  Hong Kong,  Hungary,  India,  Ireland,  Italy,  Netherlands,  Norway,  Poland,  South Africa,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c Change From Baseline at Week 52 This co-primary endpoint, change from baseline, reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications. Baseline and week 52 No
Primary HbA1c Change From Baseline at Week 104 This co-primary endpoint, change from baseline, reflects the Week 104 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications. Baseline and week 104 No
Secondary Body Weight Change From Baseline at Week 52 This key secondary endpoint, change from baseline, reflects the Week 52 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications. Baseline and week 52 No
Secondary Body Weight Change From Baseline at Week 104 This key secondary endpoint, change from baseline, reflects the Week 104 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications. Baseline and week 104 No
Secondary Incidence of Hypoglycaemic Events up to 52 Weeks A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a home blood glucose monitoring (HBGM) of below 55 mg/dl (3.1 mmol/L) Week 52 No
Secondary Incidence of Hypoglycaemic Events up to 104 Weeks A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a HBGM of below 55 mg/dl (3.1 mmol/L) Week 104 No
Secondary Fasting Plasma Glucose (FPG) Change From Baseline at Week 52 This change from baseline reflects the Week 52 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and the number of previous anti-diabetic medications. Baseline and week 52 No
Secondary Fasting Plasma Glucose (FPG) Change From Baseline at Week 104 This change from baseline reflects the Week 104 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and number of previous anti-diabetic medications. Baseline and week 104 No
Secondary Percentage of Patients With HbA1c <7.0% at Week 52 The percentage of patients with an HbA1c value below 7.0% at week 52, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications. Week 52 No
Secondary Percentage of Patients With HbA1c <7.0% at Week 104 The percentage of patients with an HbA1c value below 7.0% at week 104, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications. Week 104 No
Secondary Percentage of Patients With HbA1c <6.5% at Week 52 The percentage of patients with an HbA1c value below 6.5% at week 52, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications. Week 52 No
Secondary Percentage of Patients With HbA1c <6.5% at Week 104 The percentage of patients with an HbA1c value below 6.5% at week 104, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications. Week 104 No
Secondary Percentage of Patients With HbA1c Lowering by 0.5% at Week 104 Occurrence of relative efficacy response, defined as a lowering of 0.5% HbA1c at week 104 Week 104 No
Secondary 2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104 This change from baseline reflects the Week 104 2 hr PPG minus the Baseline 2hr PPG. Means are treatment adjusted for baseline HbA1c, baseline 2hr PPG and number of previous anti-diabetic medications. Baseline and week 104 No
Secondary HbA1c Change at Week 4 Difference of base percent value [Week x(%) - baseline (%)] Baseline and week 4 No
Secondary HbA1c Change at Week 8 Baseline and week 8 No
Secondary HbA1c Change at Week 12 Baseline and week 12 No
Secondary HbA1c Change at Week 16 Baseline and week 16 No
Secondary HbA1c Change at Week 28 Baseline and week 28 No
Secondary HbA1c Change at Week 40 Baseline and week 40 No
Secondary HbA1c Change at Week 52 Baseline and week 52 No
Secondary HbA1c Change at Week 65 Baseline and week 65 No
Secondary HbA1c Change at Week 78 Baseline and week 78 No
Secondary HbA1c Change at Week 91 Baseline and week 91 No
Secondary HbA1c Change at Week 104 The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last observation carried forward (LOCF) was used as imputation rule. Baseline and week 104 No
Secondary Change in Baseline Lipid Parameter Cholesterol at Week 104 Baseline and week 104 No
Secondary Change in Baseline Lipid Parameter HDL at Week 104 Baseline and week 104 No
Secondary Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104 Baseline and week 104 No
Secondary Change in Baseline Lipid Parameter Triglyceride at Week 104 Baseline and week 104 No
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