Randomized, Double-blind (db), Placebo-controlled 18 Week Study of Linagliptin (BI 1356) in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug

NCT00819091 | Completed Phase 3 Results

• 2 other identifiers: 1218.352008-003118-86
• Study Type: interventional
• Target: 245
• Locations: 7 countries
• Sites: 45

Brief Summary

Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18

  HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.

  Baseline, week 18

Secondary Outcomes (9)

• Change From Baseline in Fasting Plasma Glucose at Week 18

  Baseline, week 18

• Percentage of Patients With Absolute Efficacy Response (HbA1c < 7%) at Week 18

  week 18

• Percentage of Patients With Absolute Efficacy Response (HbA1c < 6.5%) at Week 18

  week 18

• Percentage of Patients With HbA1c Lowering by at Least 0.5% From Baseline at Week 18

  Baseline, week 18

• Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 6

  Baseline, week 6

Study Arms (2)

BI 1356

ACTIVE COMPARATOR

5 mg orally (po) once daily

Drug: BI 1356

Placebo

PLACEBO COMPARATOR

one tablet once daily

Drug: Placebo

Interventions

BI 1356 DRUG

5mg orally (po) tablet qd

BI 1356

Placebo DRUG

Placebo matching BI 1356 5mg one tablet daily

Placebo

Eligibility Criteria

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

You may qualify if:

• Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control \[glycosylated hemoglobin (HbA1c 7% to 10%)\] despite therapy with a sulfonylurea drug

You may not qualify if:

• Myocardial infarction,stroke or transient ischaemic attack in last 6 months Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in the past 3 months Impaired hepatic function Severe renal impairment Current treatment with systemic steroids Change in thyroid hormone dosage Hereditary galactose intolerance

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (45)

1218.35.10002 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

1218.35.10001 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1218.35.10016 Boehringer Ingelheim Investigational Site

National City, California, United States

Location

1218.35.10017 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Location

1218.35.10021 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Location

1218.35.10013 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1218.35.10015 Boehringer Ingelheim Investigational Site

Flint, Michigan, United States

Location

1218.35.10018 Boehringer Ingelheim Investigational Site

Asheville, North Carolina, United States

Location

1218.35.10004 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

1218.35.10005 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Location

1218.35.10020 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Location

1218.35.10009 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1218.35.10019 Boehringer Ingelheim Investigational Site

Sugar Land, Texas, United States

Location

1218.35.54003 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1218.35.54005 Boehringer Ingelheim Investigational Site

Corrientes, Argentina

Location

1218.35.54001 Boehringer Ingelheim Investigational Site

Mar del Plata, Argentina

Location

1218.35.54006 Boehringer Ingelheim Investigational Site

Parque Velez Sarfield, Argentina

Location

1218.35.36001 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1218.35.36002 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1218.35.36004 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1218.35.36005 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1218.35.36003 Boehringer Ingelheim Investigational Site

Debrecen, Hungary

Location

1218.35.91003 Boehringer Ingelheim Investigational Site

Aligarh, Uttar Pradesh, India

Location

1218.35.91007 Boehringer Ingelheim Investigational Site

Aminjikarai, Tamilnadu, India

Location

1218.35.91001 Boehringer Ingelheim Investigational Site

Bangalore, Karnataka, India

Location

1218.35.91004 Boehringer Ingelheim Investigational Site

Bangalore, Karnataka, India

Location

1218.35.91002 Boehringer Ingelheim Investigational Site

Indore, India

Location

1218.35.91008 Boehringer Ingelheim Investigational Site

Mumbai, Maharastra, India

Location

1218.35.91005 Boehringer Ingelheim Investigational Site

Nagpur, Maharashtra, India

Location

1218.35.91006 Boehringer Ingelheim Investigational Site

Pune, Maharastra, India

Location

1218.35.81003 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

1218.35.81001 Boehringer Ingelheim Investigational Site

Shinjyuku-ku,Tokyo, Japan

Location

1218.35.81002 Boehringer Ingelheim Investigational Site

Suita, Osaka,, Japan

Location

1218.35.48002 Boehringer Ingelheim Investigational Site

Bialystok, Poland

Location

1218.35.48004 Boehringer Ingelheim Investigational Site

Lublin, Poland

Location

1218.35.48003 Boehringer Ingelheim Investigational Site

Poznan, Poland

Location

1218.35.48001 Boehringer Ingelheim Investigational Site

Rzeszów, Poland

Location

1218.35.48005 Boehringer Ingelheim Investigational Site

Wroclaw, Poland

Location

1218.35.70008 Boehringer Ingelheim Investigational Site

Arkhangelsk, Russia

Location

1218.35.70001 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1218.35.70002 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1218.35.70003 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1218.35.70006 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1218.35.70009 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1218.35.70007 Boehringer Ingelheim Investigational Site

Yaroslavl, Russia

Location

Related Publications (3)

• McGill JB, Barnett AH, Lewin AJ, Patel S, Neubacher D, von Eynatten M, Woerle HJ. Linagliptin added to sulphonylurea in uncontrolled type 2 diabetes patients with moderate-to-severe renal impairment. Diab Vasc Dis Res. 2014 Jan;11(1):34-40. doi: 10.1177/1479164113507068. Epub 2013 Oct 29.

  PMID: 24169807 DERIVED

• Lewin AJ, Arvay L, Liu D, Patel S, von Eynatten M, Woerle HJ. Efficacy and tolerability of linagliptin added to a sulfonylurea regimen in patients with inadequately controlled type 2 diabetes mellitus: an 18-week, multicenter, randomized, double-blind, placebo-controlled trial. Clin Ther. 2012 Sep;34(9):1909-19.e15. doi: 10.1016/j.clinthera.2012.07.008. Epub 2012 Aug 29.

  PMID: 22939034 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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Linagliptin

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 7, 2009
• First Posted: January 8, 2009
• Study Start: December 1, 2008
• Primary Completion: January 1, 2010
• Last Updated: June 27, 2014
• Results First Posted: August 1, 2011

Record last verified: 2013-12

Locations

JP (3); RU (7); US (13); HU (5); AR (4); IN (8); PL (5)