Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00954447
First received: August 6, 2009
Last updated: December 4, 2013
Last verified: October 2012
  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:


Further study details as provided by Boehringer Ingelheim:

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:

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

Exclusion criteria:

  1. Uncontrolled hyperglycemia during Run-in
  2. Myocardial infarction, stroke or TIA within 3 months prior to informed consent
  3. Liver impairment; gastric surgery; medical history of cancer in last 5 years
  4. Other antidiabetic drugs, antiobesity drugs, systemic steroids, other investigational drug before randomisation
  5. Unsufficient birth control, pregnancy and nursing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 169 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
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: December 4, 2013
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
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014