Clinical trial NCT00996658: Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone
Official title: A Phase III, Randomised, Double Blind, Placebo Controlled Parallel Group Efficacy and Safety Study of Linagliptin 5 mg Administered Orally Once Daily Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite a Therapy of Metformin in Combination With Pioglitazone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2009-10-16
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

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

Exclusion criteria:

1. Uncontrolled hyperglycaemia during run in period
2. Myocardial infarction, stroke or transient ischaemic accident within 3 months prior to informed consent
3. Impaired hepatic function
4. Gastric by pass surgery
5. Treatment with roziglitazone, GLP 1 analogues, DPP-4 inhibitors or insulin within 3 months prior to informed consent
6. Treatment with anti-obesity drugs
7. 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
8. 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

Primary outcomes:
measure: Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks
timeFrame: baseline, 24 weeks
Secondary outcomes:
measure: Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks
timeFrame: baseline, 6 weeks
measure: Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks
timeFrame: baseline, 12 weeks
measure: Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks
timeFrame: baseline, 18 weeks
measure: Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks
timeFrame: 24 weeks
measure: Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks
timeFrame: 24 weeks
measure: Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks
timeFrame: 24 weeks
measure: Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks
timeFrame: baseline, 24 weeks
measure: Change From Baseline in Fasting Plasma Glucose (FPG) After 6 Weeks
timeFrame: baseline, 6 weeks
measure: Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks
timeFrame: baseline, 12 weeks
measure: Change From Baseline in Fasting Plasma Glucose (FPG) After 18 Weeks
timeFrame: baseline, 18 weeks
Other outcomes:
Locations:
city: Escondido
country: United States
facility: 1218.61.01028 Boehringer Ingelheim Investigational Site
state: California
city: Greenbrae
country: United States
facility: 1218.61.01014 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 1218.61.01015 Boehringer Ingelheim Investigational Site
state: California
city: Paramount
country: United States
facility: 1218.61.01042 Boehringer Ingelheim Investigational Site
state: California
city: Poway
country: United States
facility: 1218.61.01046 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 1218.61.01044 Boehringer Ingelheim Investigational Site
state: California
city: Miami
country: United States
facility: 1218.61.01009 Boehringer Ingelheim Investigational Site
state: Florida
city: Lawrenceville
country: United States
facility: 1218.61.01049 Boehringer Ingelheim Investigational Site
state: Georgia
city: Roswell
country: United States
facility: 1218.61.01008 Boehringer Ingelheim Investigational Site
state: Georgia
city: Meridian
country: United States
facility: 1218.61.01040 Boehringer Ingelheim Investigational Site
state: Idaho
city: Chicago
country: United States
facility: 1218.61.01016 Boehringer Ingelheim Investigational Site
state: Illinois
city: Chicago
country: United States
facility: 1218.61.01018 Boehringer Ingelheim Investigational Site
state: Illinois
city: Lafayette
country: United States
facility: 1218.61.01048 Boehringer Ingelheim Investigational Site
state: Indiana
city: Auburn
country: United States
facility: 1218.61.01001 Boehringer Ingelheim Investigational Site
state: Maine
city: Olive Branch
country: United States
facility: 1218.61.01043 Boehringer Ingelheim Investigational Site
state: Mississippi
city: Las Vegas
country: United States
facility: 1218.61.01052 Boehringer Ingelheim Investigational Site
state: Nevada
city: New York
country: United States
facility: 1218.61.01030 Boehringer Ingelheim Investigational Site
state: New York
city: Greensboro
country: United States
facility: 1218.61.01007 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Jacksonville
country: United States
facility: 1218.61.01004 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: 1218.61.01023 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Perrysburg
country: United States
facility: 1218.61.01027 Boehringer Ingelheim Investigational Site
state: Ohio
city: East Providence
country: United States
facility: 1218.61.01031 Boehringer Ingelheim Investigational Site
state: Rhode Island
city: Simpsonville
country: United States
facility: 1218.61.01017 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: 1218.61.01005 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1218.61.01006 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1218.61.01053 Boehringer Ingelheim Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: 1218.61.01003 Boehringer Ingelheim Investigational Site
state: Texas
city: Bennington
country: United States
facility: 1218.61.01024 Boehringer Ingelheim Investigational Site
state: Vermont
city: Spokane
country: United States
facility: 1218.61.01020 Boehringer Ingelheim Investigational Site
state: Washington
city: Besancon
country: France
facility: 1218.61.3301A Boehringer Ingelheim Investigational Site
city: Beziers
country: France
facility: 1218.61.3306A Boehringer Ingelheim Investigational Site
city: Beziers
country: France
facility: 1218.61.3311A Boehringer Ingelheim Investigational Site
city: Bourg des cptes
country: France
facility: 1218.61.3309A Boehringer Ingelheim Investigational Site
city: Cournonterral
country: France
facility: 1218.61.3310A Boehringer Ingelheim Investigational Site
city: Laval
country: France
facility: 1218.61.3312A Boehringer Ingelheim Investigational Site
city: Louvigne De bais
country: France
facility: 1218.61.3313A Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1218.61.3305A Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1218.61.3307A Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1218.61.91002 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1218.61.91003 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1218.61.91004 Boehringer Ingelheim Investigational Site
city: Hyderabad
country: India
facility: 1218.61.91008 Boehringer Ingelheim Investigational Site
city: Jaipur
country: India
facility: 1218.61.91009 Boehringer Ingelheim Investigational Site
city: Karnataka
country: India
facility: 1218.61.91010 Boehringer Ingelheim Investigational Site
city: Maharashtra
country: India
facility: 1218.61.91001 Boehringer Ingelheim Investigational Site
city: Maharashtra
country: India
facility: 1218.61.91006 Boehringer Ingelheim Investigational Site
city: Maharashtra
country: India
facility: 1218.61.91011 Boehringer Ingelheim Investigational Site
city: Mumbai
country: India
facility: 1218.61.91005 Boehringer Ingelheim Investigational Site
city: Mumbai
country: India
facility: 1218.61.91007 Boehringer Ingelheim Investigational Site
city: Cebu City
country: Philippines
facility: 1218.61.63003 Boehringer Ingelheim Investigational Site
city: Cebu City
country: Philippines
facility: 1218.61.63004 Boehringer Ingelheim Investigational Site
city: Davao City
country: Philippines
facility: 1218.61.63002 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.