A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate

NCT00740051 | Completed Phase 3 Results

• 2 other identifiers: 1218.502007-007485-38
• Study Type: interventional
• Target: 227
• Locations: 7 countries
• Sites: 53

Brief Summary

Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). The second part of the study looks at the safety of BI 1356 in this patient population with longer term treatment in comparison to a sulfonylurea drug (glimepiride)

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• HbA1c Change From Baseline at Week 18 (Interim Analysis)

  HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.

  Baseline and week 18

• HbA1c Change From Baseline at Week 18 (Final Analysis)

  HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. The primary analysis was re-run at the completion of the study in the final study report.

  Baseline and week 18

Secondary Outcomes (6)

• Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis)

  Baseline and week 18

• Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis)

  Week 18

• Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis)

  Week 18

• Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis)

  Week 18

• The Change in HbA1c From Baseline by Visit Over Time

  Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52

Study Arms (3)

Linagliptin

EXPERIMENTAL

52 week treatment

Drug: Linagliptin

Placebo

PLACEBO COMPARATOR

First 18 weeks of treatment

Drug: Linagliptin Placebo

Glimepiride

ACTIVE COMPARATOR

Placebo patients switch to glimepiride week19-52

Drug: Glimepiride

Interventions

Linagliptin DRUG

5mg once daily

Linagliptin

Linagliptin Placebo DRUG

0 mg placebo comparator for part 1 of study (to 18 weeks)

Placebo

Glimepiride DRUG

1-4mg for part 2 of study (weeks 19-52)

Glimepiride

Eligibility Criteria

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (53)

1218.50.10009 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

1218.50.10011 Boehringer Ingelheim Investigational Site

Peoria, Arizona, United States

Location

1218.50.10013 Boehringer Ingelheim Investigational Site

Greenbrae, California, United States

Location

1218.50.10016 Boehringer Ingelheim Investigational Site

Harbor City, California, United States

Location

1218.50.10017 Boehringer Ingelheim Investigational Site

Huntington Park, California, United States

Location

1218.50.10006 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1218.50.10007 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1218.50.10004 Boehringer Ingelheim Investigational Site

Statesville, North Carolina, United States

Location

1218.50.10002 Boehringer Ingelheim Investigational Site

Eugene, Oregon, United States

Location

1218.50.10015 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

Location

1218.50.10005 Boehringer Ingelheim Investigational Site

Kingsport, Tennessee, United States

Location

1218.50.10012 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1218.50.10022 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1218.50.10010 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1218.50.10018 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1218.50.11001 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Location

1218.50.11003 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Location

1218.50.11005 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Location

1218.50.11002 Boehringer Ingelheim Investigational Site

Montague, Prince Edward Island, Canada

Location

1218.50.11004 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Location

1218.50.52007 Boehringer Ingelheim Investigational Site

Aguascalientes, Mexico

Location

1218.50.52010 Boehringer Ingelheim Investigational Site

Guadalajara, Mexico

Location

1218.50.52009 Boehringer Ingelheim Investigational Site

León, Mexico

Location

1218.50.52002 Boehringer Ingelheim Investigational Site

México, Mexico

Location

1218.50.52004 Boehringer Ingelheim Investigational Site

México, Mexico

Location

1218.50.52005 Boehringer Ingelheim Investigational Site

México, Mexico

Location

1218.50.52008 Boehringer Ingelheim Investigational Site

México, Mexico

Location

1218.50.52001 Boehringer Ingelheim Investigational Site

Monterrey, Mexico

Location

1218.50.52003 Boehringer Ingelheim Investigational Site

Monterrey, Mexico

Location

1218.50.63003 Boehringer Ingelheim Investigational Site

Cebu, Philippines

Location

1218.50.63005 Boehringer Ingelheim Investigational Site

Cebu, Philippines

Location

1218.50.63006 Boehringer Ingelheim Investigational Site

Manila, Philippines

Location

1218.50.63008 Boehringer Ingelheim Investigational Site

Manila, Philippines

Location

1218.50.63001 Boehringer Ingelheim Investigational Site

Marikina City, Philippines

Location

1218.50.63004 Boehringer Ingelheim Investigational Site

Marikina City, Philippines

Location

1218.50.63007 Boehringer Ingelheim Investigational Site

Pasay, Philippines

Location

1218.50.63002 Boehringer Ingelheim Investigational Site

Pasig, Philippines

Location

1218.50.63009 Boehringer Ingelheim Investigational Site

Pasig, Philippines

Location

1218.50.40004 Boehringer Ingelheim Investigational Site

Brasov, Romania

Location

1218.50.40001 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1218.50.40002 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1218.50.40005 Boehringer Ingelheim Investigational Site

Galati, Romania

Location

1218.50.40003 Boehringer Ingelheim Investigational Site

Sibiu, Romania

Location

1218.50.70001 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.50.70003 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1218.50.70002 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1218.50.70004 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1218.50.70005 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1218.50.38002 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1218.50.38001 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1218.50.38004 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1218.50.38003 Boehringer Ingelheim Investigational Site

Lviv, Ukraine

Location

1218.50.38005 Boehringer Ingelheim Investigational Site

Vinnitsa, Ukraine

Location

Related Publications (2)

• Barnett AH, Patel S, Harper R, Toorawa R, Thiemann S, von Eynatten M, Woerle HJ. Linagliptin monotherapy in type 2 diabetes patients for whom metformin is inappropriate: an 18-week randomized, double-blind, placebo-controlled phase III trial with a 34-week active-controlled extension. Diabetes Obes Metab. 2012 Dec;14(12):1145-54. doi: 10.1111/dom.12011. Epub 2012 Oct 1.

  PMID: 22974280 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

Primary analysis (at interim) was rerun using final study database

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

Study Record Dates

• First Submitted: August 21, 2008
• First Posted: August 22, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2010
• Last Updated: June 27, 2014
• Results First Posted: October 26, 2011

Record last verified: 2013-12

Locations

RO (5); UA (5); RU (5); ME (9); PH (9); US (15); CA (5)