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

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ClinicalTrials.gov Identifier: NCT00954447
Recruitment Status : Completed
First Posted : August 7, 2009
Results First Posted : September 27, 2012
Last Update Posted : December 30, 2013
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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 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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Placebo Drug: Linagliptin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1263 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : August 2009
Actual Primary Completion Date : September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Linagliptin

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in HbA1c After 24 Weeks [ Time Frame: Baseline and 24 weeks ]
    HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)


Secondary Outcome Measures :
  1. Number of Patients With HbA1c < 7.0 Percent [ Time Frame: 24 and 52 weeks ]
  2. Number of Patients Lowering HbA1c by at Least 0.5 Percent [ Time Frame: 24 and 52 weeks ]
  3. Change From Baseline in HbA1c by Visit at Week 6 [ Time Frame: Baseline and 6 weeks ]
    Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs

  4. Change From Baseline in HbA1c by Visit at Week 12 [ Time Frame: Baseline and 12 weeks ]
    Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs

  5. Change From Baseline in HbA1c by Visit at Week 18 [ Time Frame: Baseline and 18 weeks ]
    Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs

  6. Change From Baseline in HbA1c by Visit at Week 32 [ Time Frame: Baseline and 32 weeks ]
    Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs

  7. Change From Baseline in HbA1c by Visit at Week 40 [ Time Frame: Baseline and 40 weeks ]
    Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs

  8. Change From Baseline in HbA1c by Visit at Week 52 [ Time Frame: Baseline and 52 weeks ]
    Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs

  9. Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment [ Time Frame: Baseline and 24 weeks ]
    Means adjusted for treatment, baseline HbA1c, baseline FPG, categorical renal function impairment and concomitant OADs

  10. Change From Baseline in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ]
  11. Change From Baseline in FPG [ Time Frame: Baseline, 6, 12, 18, 24, 32 and 40 weeks ]
  12. Change From Baseline in Mean Insulin Dose at 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ]
    Means adjusted for treatment, continous baseline HbA1c, continous baseline weight, continous baseline Insulin, categorical renal function impairment and concomitant OADs

  13. Change From Baseline in Weighted Mean Daily Glucose After 24 and 52 Weeks of Treatment [ Time Frame: Baseline, 24 and 52 weeks ]
    Mean Daily Glucose was calculated using the 8-point blood glucose profile

  14. 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 ]

Other Outcome Measures:
  1. Number of Patients With HbA1c < 6.5 Percent [ Time Frame: 24 and 52 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00954447


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00954447    
Other Study ID Numbers: 1218.36
2008-008296-33 ( EudraCT Number: EudraCT )
First Posted: August 7, 2009    Key Record Dates
Results First Posted: September 27, 2012
Last Update Posted: December 30, 2013
Last Verified: October 2012
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
 Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action