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Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01734785
First received: November 16, 2012
Last updated: November 5, 2014
Last verified: November 2014

November 16, 2012
November 5, 2014
January 2013
March 2015   (final data collection date for primary outcome measure)
HbA1c change from baseline after 24 weeks double-blind randomized treatment [ Time Frame: 24 WEEKS ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01734785 on ClinicalTrials.gov Archive Site
  • Fasting plasma glucose (FPG) change from baseline after 24 weeks of double-blind treatment. [ Time Frame: 24 WEEKS ] [ Designated as safety issue: No ]
  • Body weight change from baseline after 24 weeks of double-blind treatment [ Time Frame: 24 WEEKS ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes
A Phase III, Randomised, Double-blind, Parallel Group, 24 Week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg and 25 mg Compared to Placebo, All Administered as Oral Fixed Dose Combinations With Linagliptin 5 mg, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks Treatment With Linagliptin 5 mg Once Daily on Metformin Background Therapy.

This trial will compare the use of the FDC of empagliflozin and linagliptin to linagliptin alone as add-on to metformin in patients with T2DM.

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: Linagliptin
    tablet
  • Drug: Empagliflozin + Linagliptin
    Fixed dose combination.
  • Drug: Empagliflozin + Linagliptin
    Fixed dose combination
  • Drug: Empaglifozin placebo + Linagliptin placebo
    Matching Empaglifozin + Linagliptin low dose
  • Active Comparator: Linagliptin
    5 mg once daily
    Interventions:
    • Drug: Linagliptin
    • Drug: Empaglifozin placebo + Linagliptin placebo
  • Experimental: Empaglifozin + Linagliptin low dose
    1 tablet once daily
    Interventions:
    • Drug: Empagliflozin + Linagliptin
    • Drug: Empagliflozin + Linagliptin
  • Experimental: Empagliflozin + Linagliptin high dose
    1 tablet once daily
    Interventions:
    • Drug: Empagliflozin + Linagliptin
    • Drug: Empagliflozin + Linagliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
607
March 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Diagnosis of type 2 diabetes mellitus.
  2. Male and female patients on diet and exercise regimen, pre-treated with immediate release metformin for at least 12 weeks, and patients should be on a dose higher or equal to 1500 mg/day of metformin, or maximum tolerated dose, or maximum dose as per local label.
  3. HbA1c higher or equal to 8.0% and lower or equal to 10.5% at screening visit.
  4. Age 18 years or more at screening.
  5. Body Mass Index lower or equal to 45 kg/m2 at screening visit.
  6. Signed and dated written informed consent.

Exclusion criteria:

  1. Uncontrolled hyperglycemia with glucose level above 270 mg/dl (above 15 mmol/dl) after an overnight fast.
  2. Use of any other antidiabetic drug (except metformin background therapy).
  3. Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent.
  4. Indication of liver disease.
  5. Impaired renal function.
  6. Gastrointestinal surgery.
  7. Treatment with anti-obesity drugs within 3 months prior to screening, or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight.
  8. Current treatment with systemic steroids at time of informed consent or uncontrolled endocrine disorder except type 2 diabetes mellitus.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Brazil,   Canada,   El Salvador,   France,   Korea, Republic of,   New Zealand,   Norway,   Spain,   Taiwan
 
NCT01734785
1275.9, 2012-002270-31
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
November 2014

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