Linagliptin 2.5 mg Twice Daily Versus 5 mg Once Daily as add-on Therapy to Twice Daily Metformin in Type 2 Diabetes

NCT01012037 | Completed Phase 2 Results

• 2 other identifiers: 1218.622009-013549-27
• Study Type: interventional
• Target: 491
• Locations: 9 countries
• Sites: 84

Brief Summary

The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily compared to 5 mg once daily and each treatment's superiority over placebo.

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 baseline HbA1c percent. Treatment means are adjusted for baseline HbA1c and use of prior oral antidiabetics (OADs) in addition to background metformin.

  Baseline and week 12

Secondary Outcomes (9)

• HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis

  Baseline and week 6

• HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis

  Baseline and week 12

• FPG Change From Baseline at Week 12

  Baseline and week 12

• FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis

  Baseline and week 6

• FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis

  Baseline and week 12

Study Arms (3)

linagliptin low dose

EXPERIMENTAL

linagliptin low dose twice daily

Drug: linagliptin low dose

placebo

PLACEBO COMPARATOR

placebo matching linagliptin

Drug: placebo

linagliptin medium dose

EXPERIMENTAL

linagliptin medium dose once daily

Drug: linagliptin medium dose

Interventions

linagliptin low dose DRUG

patient to receive tablets containing low dose linagliptin twice daily

linagliptin low dose

placebo DRUG

patient to receive placebo tablet(s) matching linagliptin

placebo

linagliptin medium dose DRUG

patient to receive a tablet containing medium dose linagliptin once daily

linagliptin medium dose

Eligibility Criteria

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

You may qualify if:

• Diagnosis of type 2 diabetes mellitus.
• Current treatment with metformin alone (\>/= 1500 mg or maximally tolerated dose) or metformin plus 1 other antidiabetic drug. Metformin must be administered in twice daily dosing regimen. Patients taking metformin three times daily can be included if posology is switched to twice daily and total daily dose is maintained.
• Glycosylated haemoglobin (HbA1c) is between 7.0% - 10.0%.
• Body Mass Index (BMI) \</=45 kg/m2.

You may not qualify if:

• Treatment with extended release metformin.
• Uncontrolled hyperglycaemia (fasting plasma glucose \> 240 mg/dL or 13.3 mmol/L).
• Myocardial infarction (MI), stroke or transient ischaemic attack (TIA) within 6 months prior to informed consent.
• Impaired hepatic or renal function, or gastric bypass surgery.
• Treatment with glitazones, glucagon like peptide-1 (GLP-1) analogues/mimetics, antiobesity agents, or insulin within 3 months of informed consent.
• Current treatment with systemic steroids or change in dosage of thyroid hormones.
• Alcohol or drug abuse within 3 months of informed consent.
• Participation in another trial with investigational drug within 2 months prior to informed consent.
• Pre-menopausal women who are nursing, pregnant or not practicing an acceptable method of birth control.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (84)

1218.62.32003 Boehringer Ingelheim Investigational Site

De Pinte, Belgium

Location

1218.62.32008 Boehringer Ingelheim Investigational Site

Kortenaken, Belgium

Location

1218.62.32009 Boehringer Ingelheim Investigational Site

Kumtich, Belgium

Location

1218.62.32005 Boehringer Ingelheim Investigational Site

Massemen-Wetteren, Belgium

Location

1218.62.32004 Boehringer Ingelheim Investigational Site

Natoye, Belgium

Location

1218.62.32007 Boehringer Ingelheim Investigational Site

Sint-Job-in't-Goor, Belgium

Location

1218.62.32002 Boehringer Ingelheim Investigational Site

Tessenderlo, Belgium

Location

1218.62.32006 Boehringer Ingelheim Investigational Site

Wilsele, Belgium

Location

1218.62.11012 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Location

1218.62.11007 Boehringer Ingelheim Investigational Site

Burnaby, British Columbia, Canada

Location

1218.62.11011 Boehringer Ingelheim Investigational Site

St. John's, Newfoundland and Labrador, Canada

Location

1218.62.11006 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

Location

1218.62.11001 Boehringer Ingelheim Investigational Site

Barrie, Ontario, Canada

Location

1218.62.11003 Boehringer Ingelheim Investigational Site

Brampton, Ontario, Canada

Location

1218.62.11004 Boehringer Ingelheim Investigational Site

Markham, Ontario, Canada

Location

1218.62.11005 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Location

1218.62.11008 Boehringer Ingelheim Investigational Site

Smiths Falls, Ontario, Canada

Location

1218.62.11013 Boehringer Ingelheim Investigational Site

Strathroy, Ontario, Canada

Location

1218.62.11014 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1218.62.11010 Boehringer Ingelheim Investigational Site

Charlottetown, Prince Edward Island, Canada

Location

1218.62.11002 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1218.62.11009 Boehringer Ingelheim Investigational Site

Point Claire, Quebec, Canada

Location

1218.62.3303C Boehringer Ingelheim Investigational Site

Bort-les-Orgues, France

Location

1218.62.3306A Boehringer Ingelheim Investigational Site

Bourg Des Cptes, France

Location

1218.62.3303D Boehringer Ingelheim Investigational Site

Bugeat, France

Location

1218.62.3302H Boehringer Ingelheim Investigational Site

Corsept, France

Location

1218.62.3308A Boehringer Ingelheim Investigational Site

Derval, France

Location

1218.62.3302B Boehringer Ingelheim Investigational Site

La Chapelle-sur-Erdre, France

Location

1218.62.3304A Boehringer Ingelheim Investigational Site

Levallois-Perret, France

Location

1218.62.3305A Boehringer Ingelheim Investigational Site

Marseille, France

Location

1218.62.3305B Boehringer Ingelheim Investigational Site

Marseille, France

Location

1218.62.3305G Boehringer Ingelheim Investigational Site

Marseille, France

Location

1218.62.3305H Boehringer Ingelheim Investigational Site

Marseille, France

Location

1218.62.3301A Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.62.3302A Boehringer Ingelheim Investigational Site

Nantes, France

Location

1218.62.3304B Boehringer Ingelheim Investigational Site

Paris, France

Location

1218.62.3304D Boehringer Ingelheim Investigational Site

Paris, France

Location

1218.62.3305F Boehringer Ingelheim Investigational Site

Roquevaire, France

Location

1218.62.3305I Boehringer Ingelheim Investigational Site

Roquevaire, France

Location

1218.62.3303A Boehringer Ingelheim Investigational Site

Rosiers-d'Égletons, France

Location

1218.62.3303H Boehringer Ingelheim Investigational Site

Sainte-Fortunade, France

Location

1218.62.3302I Boehringer Ingelheim Investigational Site

Sautron, France

Location

1218.62.3302G Boehringer Ingelheim Investigational Site

Vue, France

Location

1218.62.91001 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1218.62.91004 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1218.62.91003 Boehringer Ingelheim Investigational Site

Hyderabad, Andra Pradesh, India

Location

1218.62.91005 Boehringer Ingelheim Investigational Site

Nagpru, India

Location

1218.62.91002 Boehringer Ingelheim Investigational Site

Trivandrum, India

Location

1218.62.39010 Boehringer Ingelheim Investigational Site

Ancona, Italy

Location

1218.62.39006 Boehringer Ingelheim Investigational Site

Catania, Italy

Location

1218.62.39004 Boehringer Ingelheim Investigational Site

Genova, Italy

Location

1218.62.39009 Boehringer Ingelheim Investigational Site

Gissi (CH), Italy

Location

1218.62.39003 Boehringer Ingelheim Investigational Site

Palermo, Italy

Location

1218.62.39001 Boehringer Ingelheim Investigational Site

Pisa, Italy

Location

1218.62.39002 Boehringer Ingelheim Investigational Site

Pordenone, Italy

Location

1218.62.39012 Boehringer Ingelheim Investigational Site

Ravenna, Italy

Location

1218.62.39007 Boehringer Ingelheim Investigational Site

Roma, Italy

Location

1218.62.39011 Boehringer Ingelheim Investigational Site

Roma, Italy

Location

1218.62.60002 Boehringer Ingelheim Investigational Site

George Town, Malaysia

Location

1218.62.60001 Boehringer Ingelheim Investigational Site

Kelantan Kota Bahru, Malaysia

Location

1218.62.60005 Boehringer Ingelheim Investigational Site

Kuala Lumpur, Malaysia

Location

1218.62.60003 Boehringer Ingelheim Investigational Site

Putrajaya, Malaysia

Location

1218.62.60004 Boehringer Ingelheim Investigational Site

Seremban, Malaysia

Location

1218.62.31007 Boehringer Ingelheim Investigational Site

Almere Stad, Netherlands

Location

1218.62.31004 Boehringer Ingelheim Investigational Site

Breezerveld, Netherlands

Location

1218.62.31005 Boehringer Ingelheim Investigational Site

Etten-Leur, Netherlands

Location

1218.62.31002 Boehringer Ingelheim Investigational Site

Lieshout, Netherlands

Location

1218.62.31001 Boehringer Ingelheim Investigational Site

Oude Pekela, Netherlands

Location

1218.62.31008 Boehringer Ingelheim Investigational Site

Voerendaal, Netherlands

Location

1218.62.31009 Boehringer Ingelheim Investigational Site

Wildervank, Netherlands

Location

1218.62.31003 Boehringer Ingelheim Investigational Site

Woerden, Netherlands

Location

1218.62.82005 Boehringer Ingelheim Investigational Site

Goyang, South Korea

Location

1218.62.82006 Boehringer Ingelheim Investigational Site

Goyang, South Korea

Location

1218.62.82003 Boehringer Ingelheim Investigational Site

Incheon, South Korea

Location

1218.62.82004 Boehringer Ingelheim Investigational Site

Pucheon, South Korea

Location

1218.62.82002 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1218.62.82001 Boehringer Ingelheim Investigational Site

Suwon, South Korea

Location

1218.62.34003 Boehringer Ingelheim Investigational Site

Badia Del Vallés (Barcelona), Spain

Location

1218.62.34002 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat (Barcelona), Spain

Location

1218.62.34005 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1218.62.34006 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1218.62.34007 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1218.62.34001 Boehringer Ingelheim Investigational Site

Palma (Mallorca), Spain

Location

1218.62.34008 Boehringer Ingelheim Investigational Site

Palma de Mallorca, Spain

Location

Related Publications (1)

• Ross SA, Rafeiro E, Meinicke T, Toorawa R, Weber-Born S, Woerle HJ. Efficacy and safety of linagliptin 2.5 mg twice daily versus 5 mg once daily in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, placebo-controlled trial. Curr Med Res Opin. 2012 Sep;28(9):1465-74. doi: 10.1185/03007995.2012.714360. Epub 2012 Aug 13.

  PMID: 22816729 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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 10, 2009
• First Posted: November 11, 2009
• Study Start: November 1, 2009
• Primary Completion: September 1, 2010
• Last Updated: June 27, 2014
• Results First Posted: October 31, 2011

Record last verified: 2013-12

Locations

KR (6); ES (7); FR (21); CA (14); IT (10); MY (5); NL (8); BE (8); IN (5)