Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes - Full Text View

Purpose

The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Placebo Drug: Linagliptin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group Efficacy and Safety Study of Linagliptin (5 mg), Administered Orally Once Daily for at Least 52 Weeks in Type 2 Diabetic Patients in Combination With Basal Insulin Therapy

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Linagliptin

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Change From Baseline in HbA1c After 24 Weeks [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)

Secondary Outcome Measures:

Number of Patients With HbA1c < 7.0 Percent [ Time Frame: 24 and 52 weeks ] [ Designated as safety issue: No ]
Number of Patients Lowering HbA1c by at Least 0.5 Percent [ Time Frame: 24 and 52 weeks ] [ Designated as safety issue: No ]
Change From Baseline in HbA1c by Visit at Week 6 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Change From Baseline in HbA1c by Visit at Week 12 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Change From Baseline in HbA1c by Visit at Week 18 [ Time Frame: Baseline and 18 weeks ] [ Designated as safety issue: No ]
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Change From Baseline in HbA1c by Visit at Week 32 [ Time Frame: Baseline and 32 weeks ] [ Designated as safety issue: No ]
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Change From Baseline in HbA1c by Visit at Week 40 [ Time Frame: Baseline and 40 weeks ] [ Designated as safety issue: No ]
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Change From Baseline in HbA1c by Visit at Week 52 [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
Means adjusted for treatment, baseline HbA1c, baseline FPG, categorical renal function impairment and concomitant OADs
Change From Baseline in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
Change From Baseline in FPG [ Time Frame: Baseline, 6, 12, 18, 24, 32 and 40 weeks ] [ Designated as safety issue: No ]
Change From Baseline in Mean Insulin Dose at 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
Means adjusted for treatment, continous baseline HbA1c, continous baseline weight, continous baseline Insulin, categorical renal function impairment and concomitant OADs
Change From Baseline in Weighted Mean Daily Glucose After 24 and 52 Weeks of Treatment [ Time Frame: Baseline, 24 and 52 weeks ] [ Designated as safety issue: No ]
Mean Daily Glucose was calculated using the 8-point blood glucose profile
Change From Baseline in Incremental Post-prandial Glucose (iPPG) After 24 Weeks of Treatment [ Time Frame: Baseline and 24 weeks: post-breakfast, post-lunch, post-dinner ] [ Designated as safety issue: No ]

Other Outcome Measures:

Number of Patients With HbA1c < 6.5 Percent [ Time Frame: 24 and 52 weeks ] [ Designated as safety issue: No ]

Enrollment:	1263
Study Start Date:	August 2009
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Linagliptin patient receives a tablet with intended final marketed dose	Drug: Linagliptin intended final marketed dose
Placebo Comparator: Placebo patient receives a tablet identical to those containing Linagliptin	Drug: Placebo Placebo, identical to Linagliptin tablet

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Diabetes type 2, detectable C-peptide, HbA1c 7-10%
Pretreatment with basal insulin +/- Metformin or/and +/- Pioglitazone 3 Age > 18 years, BMI <= 45 kg/m2

Exclusion criteria:

Uncontrolled hyperglycemia during Run-in
Myocardial infarction, stroke or TIA within 3 months prior to informed consent
Liver impairment; gastric surgery; medical history of cancer in last 5 years
Other antidiabetic drugs, antiobesity drugs, systemic steroids, other investigational drug before randomisation
Unsufficient birth control, pregnancy and nursing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954447

Show 169 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Eli Lilly and Company

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00954447 History of Changes
Other Study ID Numbers:	1218.36, 2008-008296-33
Study First Received:	August 6, 2009
Results First Received:	August 28, 2012
Last Updated:	October 11, 2012
Health Authority:	Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica Belgium: Federal Agency for Medicinal and Health Products Brazil: National Health Surveillance Agency Canada: Health Canada Czech Republic: State Institute for Drug Control Finland: Finnish Medicines Agency Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn Greece: Ethics Committee Italy: Ethics Committee Korea: Food and Drug Administration Mexico: Federal Commission for Protection Against Health Risks Netherlands: Central Committee Research Involving Human Subjects Norway: Norwegian Medicines Agency Peru: Ministry of Health Russia: Pharmacological Committee, Ministry of Health Slovakia: State Institute for Drug Control Spain: Ministry of Health Taiwan: Department of Health United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
BI 1356
Dipeptidyl-Peptidase IV Inhibitors

Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013