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San Diego, California

  • Diabetes Mellitus, Type 2

Purpose:

The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.


Criteria:

Inclusion criteria: 1. Signed and dated ICF (Informed Consent Form) 2. Male or female on diet and exercise regime and on stable background metformin > or equal to 1500 mg or maximun dose according to local label 3. HBA1c (Glicoslated Hemoglobin) > or equal to 8% and < or equal to 10.5 % at Visit 1 4. HbA1c > or equal to 7 and < or equal to 10.5 at Visit 4 5. Age > or equal to 18 years 6. BMI (Body Mass Index) < or equal to 45 Exclusion criteria: 1. Uncontrolled hyperglycemia during open label period and placebo add on "run-in" period 2. Use of any other antidiabetic 3. Renal function below 60 ml/min/1.73 m2 4. Antiobesity drugs or aggresive diets 5. Gastorintestinal surgeries 6. Current systemic steroids or uncontrolled endocrine disorders other than Diabetes Type 2 7. Acute coronary syndrome and stroke within 3 months of informed consent 8. Known allergies to DPP-IV (Dypeptidil Peptidase IV) or SGLT-2 (Sodium Glucose Transporter 2) inhibitors


Study is Available At:


Original ID:

1275.10


NCT ID:

NCT01778049


Secondary ID:

2012-002271-34


Study Acronym:


Brief Title:

Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes


Official Title:

A Phase III, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Linagliptin 5 mg Compared to Placebo, Administered as Oral Fixed Dose Combination With Empagliflozin 10 mg or 25 mg for 24 Weeks, in Patients With Type 2 Di


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Boehringer Ingelheim


Oversight Authority:

  • Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
  • Australia: Dept of Health and Ageing Therapeutic Goods Admin
  • Canada: Canadian Institutes of Health Research
  • Germany: Federal Institute for Drugs and Medical Devices
  • Italy: Ethics Committee
  • Portugal: National Pharmacy and Medicines Institute
  • Russia: Pharmacological Committee, Ministry of Health
  • Spain: Spanish Agency of Medicines
  • Ukraine: State Pharmacological Center - Ministry of Health
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

8


Number of Groups:

0


Total Enrollment:

708


Enrollment Type:

Actual


Overall Contact Information

Official Name:Boehringer Ingelheim
Study Chair
Boehringer Ingelheim

Study Dates

Start Date:January 2013
Completion Date:March 2015
Completion Type:Actual
Primary Completion Date:March 2015
Primary Completion Type:Actual
Verification Date:April 2015
Last Changed Date:April 1, 2015
First Received Date:January 24, 2013

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Fasting plasma glucose (FPG) change from baseline (Visit 5) at 24 weeks (or Visit 9)
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Change of HbA1c after 24 weeks of treatment (at week 24 or Visit 9) from baseline (Visit 5)
Time Frame:24 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:BI 10773 / BI 1356 Placebo
Description:Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
Arm Name:Placebo add on 25 mg dose
Intervention Type:Drug
Name:BI 10773
Description:Empagliflozin active
Arm Name:Empagliflozin/Linagliptin 10/5 mg Dose.
Intervention Type:Drug
Name:BI 10773 / BI 1356 Placebo
Description:Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo
Arm Name:Empagliflozin/Linagliptin 10/5 mg Dose.
Intervention Type:Drug
Name:BI 10773 Placebo
Description:Empagliflozin placebo
Arm Name:Empagliflozin/Linagliptin 25/5 mg Dose
Intervention Type:Drug
Name:BI 10773 / BI 1356 Placebo
Description:Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
Arm Name:Empagliflozin/Linagliptin 25/5 mg Dose.
Intervention Type:Drug
Name:BI 10773
Description:Empagliflozin active
Arm Name:Empagliflozin/Linagliptin 25/5 mg Dose.
Intervention Type:Drug
Name:BI 10773
Description:Empagliflozin active
Arm Name:Empagliflozin 25 mg dose
Intervention Type:Drug
Name:BI 10773
Description:Empagliflozin active
Arm Name:Placebo add on 10 mg dose
Intervention Type:Drug
Name:BI 10773 / BI 1356 Placebo
Description:Empagliflozin / Linagliptin 10/5 mg Dose placebo FDC
Arm Name:Placebo add on 10 mg dose
Intervention Type:Drug
Name:BI 10773 / BI 1356
Description:Empagliflozin / Linagliptin 10/5 mg Dose FDC active
Arm Name:Empagliflozin/Linagliptin 10/5 mg Dose
Intervention Type:Drug
Name:BI 10773
Description:Empagliflozin active
Arm Name:Empagliflozin 10 mg dose
Intervention Type:Drug
Name:BI 10773 / BI 1356
Description:Empagliflozin / Linagliptin 25/5 mg Dose FDC active
Arm Name:Empagliflozin/Linagliptin 25/5 mg Dose
Intervention Type:Drug
Name:BI 10773 Placebo
Description:Empagliflozin placebo
Arm Name:Empagliflozin/Linagliptin 10/5 mg Dose
Intervention Type:Drug
Name:BI 10773
Description:Empagliflozin active
Arm Name:Placebo add on 25 mg dose

Study Arms

Study Arm Type:Experimental
Arm Name:Placebo add on 25 mg dose
Description:Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo add on run-in
Study Arm Type:Experimental
Arm Name:Empagliflozin/Linagliptin 25/5 mg Dose.
Description:Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
Study Arm Type:Experimental
Arm Name:Empagliflozin 25 mg dose
Description:Empagliflozin open label treatment period
Study Arm Type:Experimental
Arm Name:Empagliflozin/Linagliptin 10/5 mg Dose
Description:Empagliflozin / Linagliptin 10/5 mg Dose FDC active
Study Arm Type:Experimental
Arm Name:Empagliflozin/Linagliptin 10/5 mg Dose.
Description:Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo
Study Arm Type:Experimental
Arm Name:Empagliflozin/Linagliptin 25/5 mg Dose
Description:Empagliflozin / Linagliptin 25/5 mg Dose FDC active
Study Arm Type:Experimental
Arm Name:Placebo add on 10 mg dose
Description:Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo add on run-in
Study Arm Type:Experimental
Arm Name:Empagliflozin 10 mg dose
Description:Empagliflozin open label treatment period

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Boehringer Ingelheim
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Eli Lilly and Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 24, 2021

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