Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control

NCT00621140 | Completed Phase 3 Results

• 2 other identifiers: 1218.162007-002448-10
• Study Type: interventional
• Target: 503
• Locations: 11 countries
• Sites: 69

Brief Summary

To investigate efficacy, safety and tolerability of BI 1356 versus placebo

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c Change From Baseline at Week 24

  HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

  Baseline and week 24

Secondary Outcomes (13)

• HbA1c Change From Baseline at Week 6

  Baseline and week 6

• HbA1c Change From Baseline at Week 12

  Baseline and week 12

• HbA1c Change From Baseline at Week 18

  Baseline and week 18

• FPG Change From Baseline at Week 24

  Baseline and week 24

• FPG Change From Baseline at Week 6

  Baseline and week 6

Study Arms (2)

linagliptin 5 mg

EXPERIMENTAL

linagliptin 5 mg once daily

Drug: linagliptin

placebo

PLACEBO COMPARATOR

placebo matching linagliptin 5 mg tablets

Drug: placebo

Interventions

linagliptin DRUG

active

linagliptin 5 mg

placebo DRUG

placebo

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:

• Male or female patients with type 2 diabetes and insufficient glycaemic control.
• Age 18 or over and not older than 80 years

You may not qualify if:

• Use of more than one oral antidiabetic agent within 10 weeks prior to informed consent, insulin, glitazones or GLP-1 analogues within 3 months.
• Myocardial infarction, stroke or transient ischaemic attack within 6 months prior to informed consent.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (69)

1218.16.38605 Boehringer Ingelheim Investigational Site

Krapinske Toplice, Croatia

Location

1218.16.38604 Boehringer Ingelheim Investigational Site

Slavonski Brod, Croatia

Location

1218.16.91009 Boehringer Ingelheim Investigational Site

Andhra Pradesh, India

Location

1218.16.91002 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1218.16.91005 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1218.16.91014 Boehringer Ingelheim Investigational Site

Chennai, India

Location

1218.16.91013 Boehringer Ingelheim Investigational Site

Ghaziabad, India

Location

1218.16.91010 Boehringer Ingelheim Investigational Site

Hyderabad, India

Location

1218.16.91006 Boehringer Ingelheim Investigational Site

Jaipur, India

Location

1218.16.91011 Boehringer Ingelheim Investigational Site

Maharashtra, India

Location

1218.16.91008 Boehringer Ingelheim Investigational Site

Mangalore, India

Location

1218.16.91007 Boehringer Ingelheim Investigational Site

Manipal, India

Location

1218.16.91004 Boehringer Ingelheim Investigational Site

Mumbai, India

Location

1218.16.91003 Boehringer Ingelheim Investigational Site

Nashik, India

Location

1218.16.91012 Boehringer Ingelheim Investigational Site

Tamilnadu, India

Location

1218.16.91001 Boehringer Ingelheim Investigational Site

Trivandrum, Kerala, India

Location

1218.16.97267 Boehringer Ingelheim Investigational Site

Giv‘atayim, Israel

Location

1218.16.97263 Boehringer Ingelheim Investigational Site

Haifa, Israel

Location

1218.16.97265 Boehringer Ingelheim Investigational Site

Holon, Israel

Location

1218.16.97261 Boehringer Ingelheim Investigational Site

Jerusalem, Israel

Location

1218.16.97262 Boehringer Ingelheim Investigational Site

Nahariya, Israel

Location

1218.16.97266 Boehringer Ingelheim Investigational Site

Safed, Israel

Location

1218.16.39004 Boehringer Ingelheim Investigational Site

Catanzaro, Italy

Location

1218.16.39008 Boehringer Ingelheim Investigational Site

Genova, Italy

Location

1218.16.39002 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

1218.16.39001 Boehringer Ingelheim Investigational Site

Pisa, Italy

Location

1218.16.39006 Boehringer Ingelheim Investigational Site

Roma, Italy

Location

1218.16.60006 Boehringer Ingelheim Investigational Site

Alor Star, Malaysia

Location

1218.16.60003 Boehringer Ingelheim Investigational Site

Kelantan Kota Bahru, Malaysia

Location

1218.16.60001 Boehringer Ingelheim Investigational Site

Kuala Lumpur, Malaysia

Location

1218.16.60002 Boehringer Ingelheim Investigational Site

Kuala Lumpur, Malaysia

Location

1218.16.60004 Boehringer Ingelheim Investigational Site

Perak, Malaysia

Location

1218.16.60005 Boehringer Ingelheim Investigational Site

Perak, Malaysia

Location

1218.16.60007 Boehringer Ingelheim Investigational Site

Pulau Pinang, Malaysia

Location

1218.16.31009 Boehringer Ingelheim Investigational Site

Andijk, Netherlands

Location

1218.16.31024 Boehringer Ingelheim Investigational Site

Castricum, Netherlands

Location

1218.16.31006 Boehringer Ingelheim Investigational Site

Deurne, Netherlands

Location

1218.16.31001 Boehringer Ingelheim Investigational Site

Ewijk, Netherlands

Location

1218.16.31010 Boehringer Ingelheim Investigational Site

Losser, Netherlands

Location

1218.16.31003 Boehringer Ingelheim Investigational Site

Oude Pekela, Netherlands

Location

1218.16.31021 Boehringer Ingelheim Investigational Site

Poortvliet, Netherlands

Location

1218.16.31004 Boehringer Ingelheim Investigational Site

Rijswijk, Netherlands

Location

1218.16.31008 Boehringer Ingelheim Investigational Site

Roelofarendsveen, Netherlands

Location

1218.16.31002 Boehringer Ingelheim Investigational Site

Wildervank, Netherlands

Location

1218.16.48603 Boehringer Ingelheim Investigational Site

Lublin, Poland

Location

1218.16.48601 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1218.16.48604 Boehringer Ingelheim Investigational Site

Zabrze, Poland

Location

1218.16.40604 Boehringer Ingelheim Investigational Site

Brasov, Romania

Location

1218.16.40603 Boehringer Ingelheim Investigational Site

Galati, Romania

Location

1218.16.42103 Boehringer Ingelheim Investigational Site

Banská Bystrica, Slovakia

Location

1218.16.42102 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

1218.16.42104 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

1218.16.42105 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

1218.16.42101 Boehringer Ingelheim Investigational Site

Nové Mesto nad Váhom, Slovakia

Location

1218.16.42106 Boehringer Ingelheim Investigational Site

Šamorín, Slovakia

Location

1218.16.66001 Boehringer Ingelheim Investigational Site

Bangkok, Thailand

Location

1218.16.66002 Boehringer Ingelheim Investigational Site

Khon Kaen, Thailand

Location

1218.16.38011 Boehringer Ingelheim Investigational Site

Dnipro, Ukraine

Location

1218.16.38002 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1218.16.38004 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1218.16.38010 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1218.16.38001 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1218.16.38005 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1218.16.38008 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1218.16.38009 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1218.16.38012 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1218.16.38003 Boehringer Ingelheim Investigational Site

Lviv, Ukraine

Location

1218.16.38006 Boehringer Ingelheim Investigational Site

Vinnitsa, Ukraine

Location

1218.16.38007 Boehringer Ingelheim Investigational Site

Zaporizhzhya, Ukraine

Location

Related Publications (2)

• Del Prato S, Patel S, Crowe S, von Eynatten M. Efficacy and safety of linagliptin according to patient baseline characteristics: A pooled analysis of three phase 3 trials. Nutr Metab Cardiovasc Dis. 2016 Oct;26(10):886-92. doi: 10.1016/j.numecd.2016.06.015. Epub 2016 Jul 1.

  PMID: 27484756 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 14, 2008
• First Posted: February 22, 2008
• Study Start: February 1, 2008
• Primary Completion: May 1, 2009
• Last Updated: February 17, 2014
• Results First Posted: June 7, 2011

Record last verified: 2014-01

Locations

SL (6); MY (7); PL (3); IT (5); UA (12); IL (6); TH (2); CR (2); IN (14); RO (2); NL (10)