Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone

NCT00996658 | Completed Phase 3 Results

• 2 other identifiers: 1218.612009-013289-20
• Study Type: interventional
• Target: 278
• Locations: 4 countries
• Sites: 52

Brief Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks

  Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  baseline, 24 weeks

Secondary Outcomes (10)

• Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks

  baseline, 6 weeks

• Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks

  baseline, 12 weeks

• Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks

  baseline, 18 weeks

• Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks

  24 weeks

• Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks

  24 weeks

Study Arms (2)

Linagliptin

EXPERIMENTAL

Linagliptin tablets once daily

Drug: Linagliptin

Placebo

PLACEBO COMPARATOR

Placebo tablets once daily

Drug: Placebo

Interventions

Placebo DRUG

Placebo matching linagliptin tablets once daily

Placebo

Linagliptin DRUG

Linagliptin tablets once daily

Linagliptin

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of diabetes mellitus prior to informed consent
• Patients treated with metformin and pioglitazone (therapy should be unchanged for 12 weeks)
• Glycosylated haemoglobin A1 \>= 7.5% and \<= 10%
• Age between 18 and less than 80
• \- Body Mass index less or equal to 45

You may not qualify if:

• Uncontrolled hyperglycaemia during run in period
• Myocardial infarction, stroke or transient ischaemic accident within 3 months prior to informed consent
• Impaired hepatic function
• Gastric by pass surgery
• Treatment with roziglitazone, GLP 1 analogues, DPP-4 inhibitors or insulin within 3 months prior to informed consent
• Treatment with anti-obesity drugs
• Current treatment with systemic steroids at the time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
• Premenopausal women who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control or do not plan to continue using this method during the trial

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Eli Lilly and Company: collaborator

Study Sites (52)

1218.61.01028 Boehringer Ingelheim Investigational Site

Escondido, California, United States

Location

1218.61.01014 Boehringer Ingelheim Investigational Site

Greenbrae, California, United States

Location

1218.61.01015 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1218.61.01042 Boehringer Ingelheim Investigational Site

Paramount, California, United States

Location

1218.61.01046 Boehringer Ingelheim Investigational Site

Poway, California, United States

Location

1218.61.01044 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

1218.61.01009 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1218.61.01049 Boehringer Ingelheim Investigational Site

Lawrenceville, Georgia, United States

Location

1218.61.01008 Boehringer Ingelheim Investigational Site

Roswell, Georgia, United States

Location

1218.61.01040 Boehringer Ingelheim Investigational Site

Meridian, Idaho, United States

Location

1218.61.01016 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1218.61.01018 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1218.61.01048 Boehringer Ingelheim Investigational Site

Lafayette, Indiana, United States

Location

1218.61.01001 Boehringer Ingelheim Investigational Site

Auburn, Maine, United States

Location

1218.61.01043 Boehringer Ingelheim Investigational Site

Olive Branch, Mississippi, United States

Location

1218.61.01052 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

Location

1218.61.01030 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

1218.61.01007 Boehringer Ingelheim Investigational Site

Greensboro, North Carolina, United States

Location

1218.61.01004 Boehringer Ingelheim Investigational Site

Jacksonville, North Carolina, United States

Location

1218.61.01023 Boehringer Ingelheim Investigational Site

Wilmington, North Carolina, United States

Location

1218.61.01027 Boehringer Ingelheim Investigational Site

Perrysburg, Ohio, United States

Location

1218.61.01031 Boehringer Ingelheim Investigational Site

East Providence, Rhode Island, United States

Location

1218.61.01017 Boehringer Ingelheim Investigational Site

Simpsonville, South Carolina, United States

Location

1218.61.01005 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1218.61.01006 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1218.61.01053 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1218.61.01003 Boehringer Ingelheim Investigational Site

Sugar Land, Texas, United States

Location

1218.61.01024 Boehringer Ingelheim Investigational Site

Bennington, Vermont, United States

Location

1218.61.01020 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Location

1218.61.3301A Boehringer Ingelheim Investigational Site

Besançon, France

Location

1218.61.3306A Boehringer Ingelheim Investigational Site

Béziers, France

Location

1218.61.3311A Boehringer Ingelheim Investigational Site

Béziers, France

Location

1218.61.3309A Boehringer Ingelheim Investigational Site

Bourg Des Cptes, France

Location

1218.61.3310A Boehringer Ingelheim Investigational Site

Cournonterral, France

Location

1218.61.3312A Boehringer Ingelheim Investigational Site

Laval, France

Location

1218.61.3313A Boehringer Ingelheim Investigational Site

Louvigné-de-Bais, France

Location

1218.61.3305A Boehringer Ingelheim Investigational Site

Paris, France

Location

1218.61.3307A Boehringer Ingelheim Investigational Site

Paris, France

Location

1218.61.91002 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1218.61.91003 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1218.61.91004 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1218.61.91008 Boehringer Ingelheim Investigational Site

Hyderabad, India

Location

1218.61.91009 Boehringer Ingelheim Investigational Site

Jaipur, India

Location

1218.61.91010 Boehringer Ingelheim Investigational Site

Karnataka, India

Location

1218.61.91001 Boehringer Ingelheim Investigational Site

Maharashtra, India

Location

1218.61.91006 Boehringer Ingelheim Investigational Site

Maharashtra, India

Location

1218.61.91011 Boehringer Ingelheim Investigational Site

Maharashtra, India

Location

1218.61.91005 Boehringer Ingelheim Investigational Site

Mumbai, India

Location

1218.61.91007 Boehringer Ingelheim Investigational Site

Mumbai, India

Location

1218.61.63003 Boehringer Ingelheim Investigational Site

Cebu City, Philippines

Location

1218.61.63004 Boehringer Ingelheim Investigational Site

Cebu City, Philippines

Location

1218.61.63002 Boehringer Ingelheim Investigational Site

Davao City, Philippines

Location

Related Publications (1)

• Bajaj M, Gilman R, Patel S, Kempthorne-Rawson J, Lewis-D'Agostino D, Woerle HJ. Linagliptin improved glycaemic control without weight gain or hypoglycaemia in patients with type 2 diabetes inadequately controlled by a combination of metformin and pioglitazone: a 24-week randomized, double-blind study. Diabet Med. 2014 Dec;31(12):1505-14. doi: 10.1111/dme.12495. Epub 2014 Jul 7.

  PMID: 24824197 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

Limitations and Caveats

During the conduct of this trial, pioglitazone was removed from the market in France due to safety issues, and this resulted in premature termination of a number of French patients.

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: October 16, 2009
• Study Start: October 1, 2009
• Primary Completion: March 1, 2012
• Last Updated: March 26, 2014
• Results First Posted: March 26, 2013

Record last verified: 2014-02

Locations

US (29); FR (9); PH (3); IN (11)