Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

August 6, 2009
December 4, 2013
August 2009
September 2011   (final data collection date for primary outcome measure)
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)
The primary endpoint in this study is the change from baseline in HbA1c after 24 weeks of treatment. [ Time Frame: 24 weeks ]
Complete list of historical versions of study NCT00954447 on ClinicalTrials.gov Archive Site
  • 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 ]
HbA1c over time, treatment to target response FPG change from baseline, over time, treat to target response Insulin dose change Frequency of AE, hypoglycemic events, rescue therapy Change from baseline in vital signs, weight, waist, lipid parameters [ Time Frame: 52-130 weeks ]
Number of Patients With HbA1c < 6.5 Percent [ Time Frame: 24 and 52 weeks ] [ Designated as safety issue: No ]
Not Provided
 
Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Placebo
    Placebo, identical to Linagliptin tablet
  • Drug: Linagliptin
    intended final marketed dose
  • Experimental: Linagliptin
    patient receives a tablet with intended final marketed dose
    Intervention: Drug: Linagliptin
  • Placebo Comparator: Placebo
    patient receives a tablet identical to those containing Linagliptin
    Intervention: Drug: Placebo
Yki-Järvinen H, Rosenstock J, Durán-Garcia S, Pinnetti S, Bhattacharya S, Thiemann S, Patel S, Woerle HJ. Effects of adding linagliptin to basal insulin regimen for inadequately controlled type 2 diabetes: a ≥52-week randomized, double-blind study. Diabetes Care. 2013 Dec;36(12):3875-81. doi: 10.2337/dc12-2718. Epub 2013 Sep 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1263
Not Provided
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Belgium,   Brazil,   Canada,   Czech Republic,   Finland,   Germany,   Greece,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Norway,   Peru,   Russian Federation,   Slovakia,   Spain,   Taiwan
 
NCT00954447
1218.36, 2008-008296-33
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP