Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes

NCT00309608 | Completed Phase 2 Results

• 2 other identifiers: 1218.62005-004597-24
• Study Type: interventional
• Target: 333
• Locations: 6 countries
• Sites: 48

Brief Summary

The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metformin in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for comparison. The influence of several factors (gender, age, weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in this study.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c Change From Baseline at Week 12

  HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the HbA1c percent baseline value. Means are treatment adjusted for baseline HbA1c.

  Baseline and week 12

Secondary Outcomes (2)

• Percentage of Patients With HbA1c<=7.0% at Week 12

  week 12

• Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12

  Baseline and week 12

Study Arms (5)

Linagliptin low dose

EXPERIMENTAL

Patients receive Linagliptin low dose tablets once daily

Drug: Linagliptin

Linagliptin medium dose

EXPERIMENTAL

Patients receive Linagliptin medium dose tablets once daily

Drug: Linagliptin

Linagliptin high dose

EXPERIMENTAL

Patients receive Linagliptin high dose tablets once daily

Drug: Linagliptin

Placebo

PLACEBO COMPARATOR

Patients receive tablets identical to those containing Linagliptin low, medium and high dose

Drug: Placebo

Glimepiride

ACTIVE COMPARATOR

Patients receive Glimepiride tablets once daily

Drug: Glimepiride

Interventions

Linagliptin DRUG

Linagliptin medium dose tablet once daily

Linagliptin medium dose

Placebo DRUG

Placebo tablets once daily

Placebo

Glimepiride DRUG

Glimepiride tablets once daily

Glimepiride

Eligibility Criteria

• Age: 21 Years - 75 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 previo usly treated with metformin alone or with metformin and one other oral antidiabetic d rug
• HbA1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
• HbA1c 7.5 10.0% at screening for patients treated with metformin alone
• HbA1c 7.5 10.0% at beginning of the placebo run-in phase
• Age \> 21 and \< 75 years
• MI \> 25 and \< 40 kg/m2 (Body Mass Index)

You may not qualify if:

• Clinically relevant cardiovascular disease
• Impaired hepatic function
• Renal insufficiency or impaired renal function
• Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
• Treatment with insulin within 3 months prior to screening

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (48)

1218.6.3302A Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.6.3303A Boehringer Ingelheim Investigational Site

Joué Les Tours, France

Location

1218.6.3304A Boehringer Ingelheim Investigational Site

Joué-lès-Tours, France

Location

1218.6.3305A Euraxi Pharma

Joué-lès-Tours, France

Location

1218.6.3301A Boehringer Ingelheim Investigational Site

Paris, France

Location

1218.6.49007 Boehringer Ingelheim Investigational Site

Aschaffenburg, Germany

Location

1218.6.49013 Boehringer Ingelheim Investigational Site

Bosenheim, Germany

Location

1218.6.49008 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

1218.6.49009 Boehringer Ingelheim Investigational Site

Düsseldorf, Germany

Location

1218.6.49014 Boehringer Ingelheim Investigational Site

Heidelberg, Germany

Location

1218.6.49012 Boehringer Ingelheim Investigational Site

Immenstadt im Allgäu, Germany

Location

1218.6.49001 Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

1218.6.49005 Boehringer Ingelheim Investigational Site

Neuwied, Germany

Location

1218.6.49017 Boehringer Ingelheim Investigational Site

Offenbach A. M., Germany

Location

1218.6.49002 Boehringer Ingelheim Investigational Site

Saarbrücken, Germany

Location

1218.6.49010 Boehringer Ingelheim Investigational Site

Saint Ingbert/Oberwürzbach, Germany

Location

1218.6.49011 Boehringer Ingelheim Investigational Site

Sinsheim, Germany

Location

1218.6.49015 Boehringer Ingelheim Investigational Site

Sulzbach-Rosenberg, Germany

Location

1218.6.49016 Boehringer Ingelheim Investigational Site

Wangen, Germany

Location

1218.6.49003 Boehringer Ingelheim Investigational Site

Würzburg, Germany

Location

1218.6.42103 Boehringer Ingelheim Investigational Site

Banská Bystrica, Slovakia

Location

1218.6.42104 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

1218.6.42105 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

1218.6.42101 Boehringer Ingelheim Investigational Site

Nové Mesto nad Váhom, Slovakia

Location

1218.6.46003 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1218.6.46001 Boehringer Ingelheim Investigational Site

Malmo, Sweden

Location

1218.6.46002 Boehringer Ingelheim Investigational Site

Uddevalla, Sweden

Location

1218.6.46004 Boehringer Ingelheim Investigational Site

Uppsala, Sweden

Location

1218.6.38002 Boehringer Ingelheim Investigational Site

Dnyepropetrovsk, Ukraine

Location

1218.6.38001 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1218.6.38003 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1218.6.38005 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1218.6.44012 Boehringer Ingelheim Investigational Site

Ashford, United Kingdom

Location

1218.6.44004 Boehringer Ingelheim Investigational Site

Baillieston, Glasgow, United Kingdom

Location

1218.6.44002 Boehringer Ingelheim Investigational Site

Bath, United Kingdom

Location

1218.6.44003 Boehringer Ingelheim Investigational Site

Birmingham, United Kingdom

Location

1218.6.44013 Boehringer Ingelheim Investigational Site

Camberley, United Kingdom

Location

1218.6.44016 Boehringer Ingelheim Investigational Site

Chorley, United Kingdom

Location

1218.6.44007 Boehringer Ingelheim Investigational Site

Dundee, United Kingdom

Location

1218.6.44006 Boehringer Ingelheim Investigational Site

Exeter, United Kingdom

Location

1218.6.44005 Boehringer Ingelheim Investigational Site

Gillingham, United Kingdom

Location

1218.6.44015 Boehringer Ingelheim Investigational Site

Glasgow, United Kingdom

Location

1218.6.44008 Boehringer Ingelheim Investigational Site

Guildford, United Kingdom

Location

1218.6.44017 Boehringer Ingelheim Investigational Site

Liverpool, United Kingdom

Location

1218.6.44001 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1218.6.44018 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Location

1218.6.44009 Boehringer Ingelheim Investigational Site

Newcastle upon Tyne, United Kingdom

Location

1218.6.44019 Boehringer Ingelheim Investigational Site

Reading, United Kingdom

Location

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

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 31, 2006
• First Posted: April 3, 2006
• Study Start: April 1, 2006
• Primary Completion: August 1, 2007
• Last Updated: July 8, 2014
• Results First Posted: June 15, 2011

Record last verified: 2013-12

Locations

SE (4); UA (4); SL (4); FR (5); GB (16); DE (15)