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

NCT00622284 | Completed Phase 3 Results

• 2 other identifiers: 1218.202007-004585-40
• Study Type: interventional
• Target: 1,560
• Locations: 16 countries
• Sites: 221

Brief 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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (27)

• Body Weight Change From Baseline at Week 52

  Baseline and week 52

• Body Weight Change From Baseline at Week 104

  Baseline and week 104

• Incidence of Hypoglycaemic Events up to 52 Weeks

  Week 52

• Incidence of Hypoglycaemic Events up to 104 Weeks

  Week 104

• Fasting Plasma Glucose (FPG) Change From Baseline at Week 52

  Baseline and week 52

Study Arms (2)

BI 1356 5mg, once daily

EXPERIMENTAL

patient to receive a tablet containing 5mg BI 1356 plus one (two in US) inactive placebo capsule matching Glimepiride

Drug: Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg; Drug: BI 1356

Glimepiride

ACTIVE COMPARATOR

patient to receive 1mg or 2mg or 3mg (not in US) or 4mg Glimepiride capsule plus one inactive placebo tablet matching BI 1356 (plus one inactive placebo capsule in US)

Drug: Placebo identical to BI 1356 5mg; Drug: Glimepiride

Interventions

Placebo identical to BI 1356 5mg DRUG

Placebo tablet once daily

Glimepiride

Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg DRUG

Placebo tablets once daily

BI 1356 5mg, once daily

BI 1356 DRUG

5mg, once daily in the morning for 104 weeks

BI 1356 5mg, once daily

Glimepiride DRUG

1mg or 2mg or 3mg or 4mg in the morning for 104 weeks

Glimepiride

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Glycosylated haemoglobin (HbA1c) 6.0 - 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
• HbA1c 6.5 - 10.0% at screening for patients treated with metformin alone
• HbA1c 6.5 - 10.0% at beginning of the placebo run-in phase

You may not qualify if:

• Myocardial infarction, stroke or transient ischemic attack (TIA)
• Impaired hepatic function
• Renal failure or renal impairment
• Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
• Treatment with insulin or glucagon-like peptide 1 (GLP-1) analogue/antagonists within 3 months prior to screening

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (221)

1218.20.10033 Boehringer Ingelheim Investigational Site

Tempe, Arizona, United States

Location

1218.20.10003 Boehringer Ingelheim Investigational Site

Chula Vista, California, United States

Location

1218.20.10020 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1218.20.10035 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1218.20.10037 Boehringer Ingelheim Investigational Site

Los Gatos, California, United States

Location

1218.20.10034 Boehringer Ingelheim Investigational Site

West Palm Beach, Florida, United States

Location

1218.20.10023 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Location

1218.20.10030 Boehringer Ingelheim Investigational Site

Topeka, Kansas, United States

Location

1218.20.10028 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

1218.20.10006 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Location

1218.20.10022 Boehringer Ingelheim Investigational Site

Endwell, New York, United States

Location

1218.20.10032 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

1218.20.10031 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

1218.20.10013 Boehringer Ingelheim Investigational Site

Mentor, Ohio, United States

Location

1218.20.10045 Boehringer Ingelheim Investigational Site

Perrysburg, Ohio, United States

Location

1218.20.10042 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

1218.20.10024 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1218.20.10002 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

Location

1218.20.10007 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1218.20.10036 Boehringer Ingelheim Investigational Site

Murray, Utah, United States

Location

1218.20.10029 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Location

1218.20.10009 Boehringer Ingelheim Investigational Site

Federal Way, Washington, United States

Location

1218.20.10026 Boehringer Ingelheim Investigational Site

Renton, Washington, United States

Location

1218.20.35201 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1218.20.35202 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1218.20.35203 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1218.20.35207 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1218.20.35204 Boehringer Ingelheim Investigational Site

Stara Zagora, Bulgaria

Location

1218.20.45006 Boehringer Ingelheim Investigational Site

Aalborg, Denmark

Location

1218.20.45001 Boehringer Ingelheim Investigational Site

Aarhus C, Denmark

Location

1218.20.45011 Boehringer Ingelheim Investigational Site

Aarhus C, Denmark

Location

1218.20.45013 Boehringer Ingelheim Investigational Site

Aarhus C, Denmark

Location

1218.20.45002 Boehringer Ingelheim Investigational Site

Hvidovre, Denmark

Location

1218.20.45003 Boehringer Ingelheim Investigational Site

København NV, Denmark

Location

1218.20.45007 Boehringer Ingelheim Investigational Site

Odense, Denmark

Location

1218.20.3307A Boehringer Ingelheim Investigational Site

Joué Les Tours Cedex, France

Location

1218.20.3307B Boehringer Ingelheim Investigational Site

Joué Les Tours Cedex, France

Location

1218.20.3307C Boehringer Ingelheim Investigational Site

Joué Les Tours Cedex, France

Location

1218.20.3307D Boehringer Ingelheim Investigational Site

Joué Les Tours Cedex, France

Location

1218.20.3307E Boehringer Ingelheim Investigational Site

Joué Les Tours Cedex, France

Location

1218.20.3307F Boehringer Ingelheim Investigational Site

Joué Les Tours Cedex, France

Location

1218.20.3307G Boehringer Ingelheim Investigational Site

Joué Les Tours Cedex, France

Location

1218.20.3307H Boehringer Ingelheim Investigational Site

Joué Les Tours Cedex, France

Location

1218.20.3307I Boehringer Ingelheim Investigational Site

Joué Les Tours Cedex, France

Location

1218.20.3310A Boehringer Ingelheim Investigational Site

Joué Les Tours Cedex, France

Location

1218.20.3310B Boehringer Ingelheim Investigational Site

Joué Les Tours Cedex, France

Location

1218.20.3310C Boehringer Ingelheim Investigational Site

Joué Les Tours Cedex, France

Location

1218.20.3310D Boehringer Ingelheim Investigational Site

Joué Les Tours Cedex, France

Location

1218.20.3310E Boehringer Ingelheim Investigational Site

Joué Les Tours Cedex, France

Location

1218.20.3312A Boehringer Ingelheim Investigational Site

Joué Les Tours Cedex, France

Location

1218.20.3312B Boehringer Ingelheim Investigational Site

Joué Les Tours Cedex, France

Location

1218.20.3312C Boehringer Ingelheim Investigational Site

Joué Les Tours Cedex, France

Location

1218.20.3312D Boehringer Ingelheim Investigational Site

Joué Les Tours Cedex, France

Location

1218.20.3308A Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.20.3308C Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.20.3308D Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.20.3308E Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.20.3308F Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.20.3309A Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.20.3309B Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.20.3309C Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.20.3309D Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.20.3309E Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.20.3311A Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.20.3311B Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.20.3311C Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.20.3313A Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.20.3313B Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.20.3313C Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.20.3313D Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.20.3314A Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.20.3314B Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.20.3314C Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.20.3314D Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.20.3314E Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.20.3314F Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.20.3301A Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3302A Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3302C Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3302D Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3302E Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3302G Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3302H Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3302I Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3303A Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3303B Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3303C Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3303D Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3303E Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3303G Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3303H Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3303I Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3304A Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3304B Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3304C Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3304D Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3304F Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3304H Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3305A Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3305B Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3305H Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3306A Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3306B Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3306D Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3306F Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3306G Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3306H Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3306I Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.20.3311D Boehringer Ingelheim Investigational Site

Potigny, France

Location

1218.20.49004 Boehringer Ingelheim Investigational Site

Aschaffenburg, Germany

Location

1218.20.49028 Boehringer Ingelheim Investigational Site

Bad Mergentheim, Germany

Location

1218.20.49022 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1218.20.49024 Boehringer Ingelheim Investigational Site

Bosenheim, Germany

Location

1218.20.49012 Boehringer Ingelheim Investigational Site

Cologne, Germany

Location

1218.20.49020 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

1218.20.49018 Boehringer Ingelheim Investigational Site

Flörsheim, Germany

Location

1218.20.49015 Boehringer Ingelheim Investigational Site

Frankfurt am Main, Germany

Location

1218.20.49006 Boehringer Ingelheim Investigational Site

Großheirath, Germany

Location

1218.20.49025 Boehringer Ingelheim Investigational Site

Haag, Germany

Location

1218.20.49016 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1218.20.49029 Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

1218.20.49021 Boehringer Ingelheim Investigational Site

Hatten, Germany

Location

1218.20.49017 Boehringer Ingelheim Investigational Site

Kelkheim, Germany

Location

1218.20.49005 Boehringer Ingelheim Investigational Site

Künzing, Germany

Location

1218.20.49010 Boehringer Ingelheim Investigational Site

Leipzig, Germany

Location

1218.20.49003 Boehringer Ingelheim Investigational Site

Neuwied, Germany

Location

1218.20.49007 Boehringer Ingelheim Investigational Site

Nuremberg, Germany

Location

1218.20.49008 Boehringer Ingelheim Investigational Site

Rednitzhembach, Germany

Location

1218.20.49027 Boehringer Ingelheim Investigational Site

Saaldorf, Germany

Location

1218.20.49014 Boehringer Ingelheim Investigational Site

Saarbrücken, Germany

Location

1218.20.49019 Boehringer Ingelheim Investigational Site

Saint Ingbert/Oberwürzbach, Germany

Location

1218.20.49030 Boehringer Ingelheim Investigational Site

Speyer, Germany

Location

1218.20.49002 Boehringer Ingelheim Investigational Site

Sulzbach-Rosenberg, Germany

Location

1218.20.49009 Boehringer Ingelheim Investigational Site

Unterschneidheim, Germany

Location

1218.20.49026 Boehringer Ingelheim Investigational Site

Wangen, Germany

Location

1218.20.49011 Boehringer Ingelheim Investigational Site

Westerkappeln, Germany

Location

1218.20.49013 Boehringer Ingelheim Investigational Site

Würzburg, Germany

Location

1218.20.85201 Boehringer Ingelheim Investigational Site

Hong Kong, Hong Kong

Location

1218.20.85202 Boehringer Ingelheim Investigational Site

Hong Kong, Hong Kong

Location

1218.20.85204 Boehringer Ingelheim Investigational Site

Hong Kong, Hong Kong

Location

1218.20.36208 Boehringer Ingelheim Investigational Site

Ajka, Hungary

Location

1218.20.36205 Boehringer Ingelheim Investigational Site

Baja, Hungary

Location

1218.20.36204 Boehringer Ingelheim Investigational Site

Békéscsaba, Hungary

Location

1218.20.36206 Boehringer Ingelheim Investigational Site

Hódmezövásárhely, Hungary

Location

1218.20.36202 Boehringer Ingelheim Investigational Site

Makó, Hungary

Location

1218.20.36201 Boehringer Ingelheim Investigational Site

Miskolc, Hungary

Location

1218.20.36207 Boehringer Ingelheim Investigational Site

Mosonmagyaróvár, Hungary

Location

1218.20.36203 Boehringer Ingelheim Investigational Site

Szentes, Hungary

Location

1218.20.91022 Boehringer Ingelheim Investigational Site

Chennai, India

Location

1218.20.91024 Boehringer Ingelheim Investigational Site

Coimbatore, India

Location

1218.20.91025 Boehringer Ingelheim Investigational Site

Gujarat, India

Location

1218.20.91023 Boehringer Ingelheim Investigational Site

Hyderabad, India

Location

1218.20.91021 Boehringer Ingelheim Investigational Site

Kochi, India

Location

1218.20.91020 Boehringer Ingelheim Investigational Site

Mumbai, India

Location

1218.20.91027 Boehringer Ingelheim Investigational Site

Patna, India

Location

1218.20.91026 Boehringer Ingelheim Investigational Site

Tamilnadu, India

Location

1218.20.35307 Boehringer Ingelheim Investigational Site

Co. Cork, Ireland

Location

1218.20.35304 Boehringer Ingelheim Investigational Site

Co. Wexford, Ireland

Location

1218.20.35306 Boehringer Ingelheim Investigational Site

Co. Wexford, Ireland

Location

1218.20.35310 Boehringer Ingelheim Investigational Site

Co. Wexford, Ireland

Location

1218.20.35308 Boehringer Ingelheim Investigational Site

Dublin, Ireland

Location

1218.20.35303 Boehringer Ingelheim Investigational Site

Waterford, Ireland

Location

1218.20.39034 Boehringer Ingelheim Investigational Site

Catania, Italy

Location

1218.20.39027 Boehringer Ingelheim Investigational Site

Chieti, Italy

Location

1218.20.39029 Boehringer Ingelheim Investigational Site

Codogno (lo), Italy

Location

1218.20.39021 Boehringer Ingelheim Investigational Site

Genova, Italy

Location

1218.20.39033 Boehringer Ingelheim Investigational Site

Perugia, Italy

Location

1218.20.39022 Boehringer Ingelheim Investigational Site

Pordenone, Italy

Location

1218.20.39028 Boehringer Ingelheim Investigational Site

Ravenna, Italy

Location

1218.20.39030 Boehringer Ingelheim Investigational Site

Roma, Italy

Location

1218.20.39032 Boehringer Ingelheim Investigational Site

Roma, Italy

Location

1218.20.39020 Boehringer Ingelheim Investigational Site

Siena, Italy

Location

1218.20.31023 Boehringer Ingelheim Investigational Site

's-Hertogenbosch, Netherlands

Location

1218.20.31014 Boehringer Ingelheim Investigational Site

Almere Stad, Netherlands

Location

1218.20.31016 Boehringer Ingelheim Investigational Site

Beek en Donk, Netherlands

Location

1218.20.31011 Boehringer Ingelheim Investigational Site

Ewijk, Netherlands

Location

1218.20.31018 Boehringer Ingelheim Investigational Site

Hoogwoud, Netherlands

Location

1218.20.31012 Boehringer Ingelheim Investigational Site

Oude Pekela, Netherlands

Location

1218.20.31022 Boehringer Ingelheim Investigational Site

Rilland, Netherlands

Location

1218.20.31019 Boehringer Ingelheim Investigational Site

Roelofarendsveen, Netherlands

Location

1218.20.31013 Boehringer Ingelheim Investigational Site

Wildervank, Netherlands

Location

1218.20.47005 Boehringer Ingelheim Investigational Site

Fevik, Norway

Location

1218.20.47004 Boehringer Ingelheim Investigational Site

Fornebu, Norway

Location

1218.20.47002 Boehringer Ingelheim Investigational Site

Hamar, Norway

Location

1218.20.47001 Boehringer Ingelheim Investigational Site

Rud, Norway

Location

1218.20.47003 Boehringer Ingelheim Investigational Site

Sandvika, Norway

Location

1218.20.48210 Boehringer Ingelheim Investigational Site

Bialystok, Poland

Location

1218.20.48208 Boehringer Ingelheim Investigational Site

Gdynia, Poland

Location

1218.20.48207 Boehringer Ingelheim Investigational Site

Krakow, Poland

Location

1218.20.48201 Boehringer Ingelheim Investigational Site

Lodz, Poland

Location

1218.20.48202 Boehringer Ingelheim Investigational Site

Lodz, Poland

Location

1218.20.48203 Boehringer Ingelheim Investigational Site

Olsztyn, Poland

Location

1218.20.48206 Boehringer Ingelheim Investigational Site

Torun, Poland

Location

1218.20.48205 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1218.20.48209 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1218.20.27007 Boehringer Ingelheim Investigational Site

Bellville, South Africa

Location

1218.20.27002 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

1218.20.27006 Boehringer Ingelheim Investigational Site

Durban, South Africa

Location

1218.20.27004 Boehringer Ingelheim Investigational Site

Lenasia, South Africa

Location

1218.20.27005 Boehringer Ingelheim Investigational Site

Lenasia, South Africa

Location

1218.20.27003 Boehringer Ingelheim Investigational Site

Pretoria, South Africa

Location

1218.20.46003 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1218.20.46001 Boehringer Ingelheim Investigational Site

Malmo, Sweden

Location

1218.20.46002 Boehringer Ingelheim Investigational Site

Malmo, Sweden

Location

1218.20.46004 Boehringer Ingelheim Investigational Site

Uppsala, Sweden

Location

1218.20.44108 Boehringer Ingelheim Investigational Site

Baillieston, Glasgow, United Kingdom

Location

1218.20.44115 Boehringer Ingelheim Investigational Site

Blackpool, United Kingdom

Location

1218.20.44110 Boehringer Ingelheim Investigational Site

Bradford-on-Avon, United Kingdom

Location

1218.20.44102 Boehringer Ingelheim Investigational Site

Buckshaw Village, Chorley, United Kingdom

Location

1218.20.44114 Boehringer Ingelheim Investigational Site

Cheadle, United Kingdom

Location

1218.20.44116 Boehringer Ingelheim Investigational Site

Chestfield, Whitstable, United Kingdom

Location

1218.20.44109 Boehringer Ingelheim Investigational Site

Chippenham, United Kingdom

Location

1218.20.44113 Boehringer Ingelheim Investigational Site

Dundee, United Kingdom

Location

1218.20.44105 Boehringer Ingelheim Investigational Site

Edgbaston, Birmingham, United Kingdom

Location

1218.20.44112 Boehringer Ingelheim Investigational Site

Ely, United Kingdom

Location

1218.20.44101 Boehringer Ingelheim Investigational Site

Guildford, United Kingdom

Location

1218.20.44103 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Location

1218.20.44106 Boehringer Ingelheim Investigational Site

Trowbridge, United Kingdom

Location

1218.20.44104 Boehringer Ingelheim Investigational Site

Waterloo, Liverpool, United Kingdom

Location

1218.20.44111 Boehringer Ingelheim Investigational Site

Westbury, United Kingdom

Location

1218.20.44107 Boehringer Ingelheim Investigational Site

Whitstable, United Kingdom

Location

Related Publications (4)

• Dennis JM, Young KG, Cardoso P, Gudemann LM, McGovern AP, Farmer A, Holman RR, Sattar N, McKinley TJ, Pearson ER, Jones AG, Shields BM, Hattersley AT; MASTERMIND Consortium. A five-drug class model using routinely available clinical features to optimise prescribing in type 2 diabetes: a prediction model development and validation study. Lancet. 2025 Mar 1;405(10480):701-714. doi: 10.1016/S0140-6736(24)02617-5. Epub 2025 Feb 25.

  PMID: 40020703 DERIVED

• Gallwitz B, Rosenstock J, Emser A, von Eynatten M, Woerle HJ. Linagliptin is more effective than glimepiride at achieving a composite outcome of target HbA(1)c < 7% with no hypoglycaemia and no weight gain over 2 years. Int J Clin Pract. 2013 Apr;67(4):317-21. doi: 10.1111/ijcp.12101.

  PMID: 23521323 DERIVED

• Gallwitz B, Rosenstock J, Rauch T, Bhattacharya S, Patel S, von Eynatten M, Dugi KA, Woerle HJ. 2-year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, non-inferiority trial. Lancet. 2012 Aug 4;380(9840):475-83. doi: 10.1016/S0140-6736(12)60691-6. Epub 2012 Jun 28.

  PMID: 22748821 DERIVED

• Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3.

  PMID: 22234149 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Linagliptin; glimepiride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Limitations and Caveats

With the exception of HbA1c\<6.5% and HbA1c\<7.0% at Week52, all other endpoints are presented in the Week52 repeated analysis within the final clinical trial report, where discrepancies between interim and final results are also explained.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2008
• First Posted: February 25, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2010
• Last Updated: January 29, 2014
• Results First Posted: February 20, 2012

Record last verified: 2013-12

Locations

BU (5); DE (28); NL (9); HU (8); PL (9); NO (5); FR (74); IE (6); HK (3); IT (10); SE (4); DK (7); IN (8); GB (16); ZA (6); US (23)