Phase 3
N=709
Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT01778049 ↗Enrolled (actual)
709
Serious AEs
3.4%
Results posted
Apr 2016
Primary outcome: Primary: Change From Baseline of HbA1c After 24 Weeks of Treatment. — -0.53; -0.21; -0.58; -0.10 Percentage of HbA1c — p=0.0013
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BI 10773 (Drug); BI 10773 Placebo (Drug); BI 10773 / BI 1356 (Drug); BI 10773 / BI 1356 Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline of HbA1c After 24 Weeks of Treatment. |
-0.53; -0.21; -0.58; -0.10 | 0.0013 sig |
| SECONDARY Fasting Plasma Glucose (FPG) Change From Baseline at 24 Weeks. |
-0.44; 0.21; -0.68; -0.24 | 0.0103 sig |
Summary
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.
Eligibility Criteria
Inclusion criteria
- Signed and dated ICF (Informed Consent Form)
- 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
- HBA1c (Glicoslated Hemoglobin) > or equal to 8% and or equal to 7 and or equal to 18 years
- BMI (Body Mass Index) < or equal to 45
Exclusion criteria
- Uncontrolled hyperglycemia during open label period and placebo add on "run-in" period
- Use of any other antidiabetic
- Renal function below 60 ml/min/1.73 m2
- Antiobesity drugs or aggresive diets
- Gastorintestinal surgeries
- Current systemic steroids or uncontrolled endocrine disorders other than Diabetes Type 2
- Acute coronary syndrome and stroke within 3 months of informed consent
- Known allergies to DPP-IV (Dypeptidil Peptidase IV) or SGLT-2 (Sodium Glucose Transporter 2) inhibitors
Data sourced from ClinicalTrials.gov (NCT01778049). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.